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152. Trends in Decline of Antiretroviral Resistance among ARV-Experienced Patients in the HIV Outpatient Study:1999-2008.

Author

Buchacz, Kate, Baker, Rose, Ward, Douglas J., Palella, Frank J., Chmiel, Joan S., Young, Benjamin, Yangco, Bienvenido G., Novak, Richard M., and Brooks, John T.

Abstract

Background. Little is known about temporal trends in frequencies of clinically relevant ARV resistance mutations in HIV strains from U.S. patients undergoing genotypic testing (GT) in routine HIV care. Methods. We analyzed cumulative frequency of HIV resistance among patients in the HIV Outpatient Study (HOPS) who, during 1999-2008 and while prescribed antiretrovirals, underwent GT with plasma HIV RNA >1,000 copies/mL. Exposure ⩾4 months to each of three major antiretroviral classes (NRTI, NNRTI and PI) was defined as triple-class exposure (TCE). Results. 906 patients contributed 1,570 GT results. The annual frequency of any major resistance mutations decreased during 1999-2008 (88% to 79%, P = 0.05). Resistance to PIs decreased among PI-exposed patients (71% to 46%, P = 0.010) as exposure to ritonavir-boosted PIs increased (6% to 81%,P < 0.001). Nonsignificant declines were observed in resistance to NRTIs among NRTI-exposed (82% to 67%), and triple-class-resistance among TCE patients (66% to 41%), but not to NNRTIs among NNRTI-exposed. Conclusions. HIV resistance was common but declined in HIV isolates from subgroups of ARV-experienced HOPS patients during 1999-2008. Resistance to PIs among PI-exposed patients decreased, possibly due to increased representation of patients whose only PI exposures were to boosted PIs. [ABSTRACT FROM AUTHOR]

Published
2012
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153. SARS Cov 2 Vaccines: Current State Of The Art.

Author

Novak, Richard M.

Subjects
*BOOSTER vaccines, *COVID-19, *VACCINES, *VACCINE development, *VACCINE approval
Abstract

The sudden and rapid arrival and spread of COVID 19 led to an unprecedented vaccine development effort worldwide. The successful trials and approval of multiple vaccines has not been equaled by their acceptance, production and distribution. The predominant vaccines will be discussed and compared. Emergence of variant viruses, waning immunity and the introduction of booster doses will be discussed. The application of vaccine in pregnancy will also be addressed. [ABSTRACT FROM AUTHOR]

Published
2022

156. Reaction Times are Faster in HIV-Seropositive Patients on AntiretroviralTherapy: A Preliminary Report.

Author

Martin, Eileen M., Pitrak, David L., Novak, Richard M., Pursell, Kenneth J., and Mullane, Kathleen M.

Subjects
HIV-positive persons, DEMENTIA, PSYCHOLOGICAL distress
Abstract

We evaluated subclinical mental and motor slowing in 142 HIV-seropositive patients without dementia, using computerized simple and choice reaction time tasks and self-report measures of psychological distress. Patients on antiretroviral therapy at the time of testing (n = 79) had significantly faster choice reaction times (p < 0.05), indicating faster mental processing speed, than untreated patients (n = 63). These faster RTs could not be attributed to differences in age, education, risk factors, degree of immunosuppression, substance abuse history, peripheral neuropathy, or psychological distress. Reaction time tasks should be investigated further as potential outcome measures in clinical trials, particularly for subjects with few or no overt cognitive deficits. [ABSTRACT FROM AUTHOR]

Published
1999
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158. Prevalence and Impact of HIV-1 Protease Codon 33 Mutations and Polymorphisms in Treatment-Naive and Treatment-Experienced Patients

Author

Kozal, Michael J, Hullsiek, Katherine Huppler, Leduc, Robert, Novak, Richard M, MacArthur, Rodger D, Lawrence, Jody, and Baxter, John D

Abstract

Background HIV-1 protease gene mutations at codon 33 have been associated with resistance to some but not all protease inhibitors (PIs). Little is known about the difference in prevalence of codon 33 mutations and polymorphisms between treatment-naive and treatment-experienced patients, and the effect of codon 33F on PI phenotypic resistance patterns.Methods Baseline genotypes (TRUGENE) from 772 patients participating in two different randomized clinical trials [504 antiretroviral treatment-naive patients and 268 antiretroviral treatment-experienced patients] were evaluated for the presence of protease codon 33 mutations and polymorphisms. Baseline phenotypes (Antivirogram), including fold-change in resistance for 16 antiretroviral drugs, were available for the 268 treatment-experienced patients. Multivariate linear regression models were used to determine factors associated with phenotypic fold-change for PIs.Results The prevalence of codon 33 mutations and polymorphisms was 5.2% in the naive cohort (0.2% 33F, 2.5% 33V, 2.5% 33I) and 34.7% in the experienced cohort (30.2% 33F, 1.5% 33V, 3.0% 33I). In the antiretroviral-experienced cohort (mean = 4.2 prior PIs, 10.6 prior antiretroviral drugs overall), a model adjusting for the presence of specific major protease and multi-PI resistance conferring mutations, the number of other minor PI mutations, prior PI drug exposure (current, prior only, never), and HIV transmission risk factor was used to estimate the phenotypic fold-change in resistance for those with and without mutation 33F. Those with 33F had a significantly higher fold-change for amprenavir (33 vs 19, P<0.0001), ritonavir (162 vs 82, P<0.0001), lopinavir (49 vs 38, P=0.04), and saquinavir (47 vs 41, P=0.02). The presence of the 33F was not a significant predictor of fold change in susceptibility for indinavir or nelfinavir.Conclusions At protease codon 33, the prevalences of polymorphisms 33V and 33I were similar for PI-naive and PI-experienced patients (<3.0%), but the prevalence of 33F was significantly different (0.2% versus 30.2%). In the treatment-experienced cohort, the differences in phenotypic fold-change for amprenavir, lopinavir, saquinavir, and ritonavir between those with and without 33F persist after adjustment for the presence of other major PI mutations and PI drug exposure history. Given the availability of newer PIs that may select for 33F, monitoring for the presence of this mutation should be ongoing for both treatment-naive and treatment-experienced patients.

Published
2006
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159. Mycobacterium avium Induces HIV Upregulation through Mechanisms Independent of Cytokine Induction

Author

Ghassemi, Mahmood, Asadi, Farrokh K., Andersen, Burton R., and Novak, Richard M.

Abstract

Mycobacterium avium complex (MAC) can induce upregulation of HIV. To investigate the underlying mechanisms, the effect of MAC-induced cytokines on HIV replication was first studied. Semiquantitative RT-PCR, followed by Northern blot analysis, revealed that mRNA encoding IL-6 and TNF-alpha was induced by MAC. However, production of these cytokines was undetectable and the addition of anti-cytokine antibodies to coinfected cells could only minimally block the MAC effect on HIV. Infection of U38 cells with MAC resulted in enhancement of HIV-1 LTR-CAT transcription. In addition, transient transfection of U937 cells with fulllength wild-type as well as NF-kappa B-binding site-deleted mutant HIV-1 LTR-CAT constructs revealed that MAC-induced HIV-LTR CAT is NF-kappa B dependent. These findings, together with our previous work, indicate that MAC-induced cytokine expression increases the formation of NF-kappa B, which in turn enhances HIV1 LTR-CAT transcription. However, additional factor(s) yet to be elucidated may play a more significant role in MAC-mediated HIV-upregulation.

Published
2000
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160. Information processing and antiretroviral therapy in HIV-1 infection

Author

MARTIN, EILEEN M., PITRAK, DAVID L., PURSELL, KENNETH J., ANDERSEN, BURTON R., MULLANE, KATHLEEN M., and NOVAK, RICHARD M.

Abstract

Computerized reaction time (RT) tasks are sensitive measures of subclinical HIV-related mental slowing. We previously reported that nondemented HIV-seropositive patients on antiretroviral therapy at the time of testing had faster choice RTs compared to matched untreated seropositive participants. In the present study, we evaluated the performance of 163 nondemented HIV-seropositive participants on a reaction time version of the Stroop task as a function of antiretroviral status. Persons on antiretroviral therapy at the time of testing had significantly faster reaction times than untreated individuals, although treated asymptomatic participants showed significantly less Stroop interference than treated symptomatic participants. These effects could not be attributed to differences in demographic variables, disease status, substance abuse, or psychological distress. These data indicate that central information processing is faster for patients treated with antiretroviral compounds compared to untreated patients, and suggest that reaction time tasks may have significant potential utility in clinical trials of neuroprotective compounds. (JINS, 1998, 4, 329–335.)

Published
1998

161. Brief Report: Protease Inhibitors Versus Nonnucleoside Reverse Transcriptase Inhibitors and the Risk of Cancer Among People With HIV.

Author

Coburn, Sally B., Pimentel, Noel, Leyden, Wendy, Kitahata, Mari M., Moore, Richard D., Althoff, Keri N., Gill, M. John, Lang, Raynell, Horberg, Michael A., D'Souza, GypsyAmber, Hussain, Shehnaz K., Dubrow, Robert, Novak, Richard M., Rabkin, Charles S., Park, Lesley S., Sterling, Timothy R., Neugebauer, Romain S., Silverberg, Michael J., Benson, Constance A., and Bosch, Ronald J.

Abstract

Supplemental Digital Content is Available in the Text. Background: The effect of initial antiretroviral therapy (ART) class on cancer risk in people with HIV (PWH) remains unclear. Setting: A cohort study of 36,322 PWH enrolled (1996–2014) in the North American AIDS Cohort Collaboration on Research and Design. Methods: We followed individuals from ART initiation (protease inhibitor [PI]-based, nonnucleoside reverse transcriptase inhibitor [NNRTI]-based, or integrase strand transfer inhibitor [INSTI]-based) until incident cancer, death, loss-to-follow-up, December 31, 2014, 85 months (intention-to-treat analyses [ITT]), or 30 months (per-protocol [PP] analyses). Cancers were grouped (nonmutually exclusive) as follows: any cancer, AIDS-defining cancers (ADC), non-AIDS-defining cancers (NADC), any infection-related cancer, and common individual cancer types. We estimated adjusted hazard ratios (aHR) comparing cancer risk by ART class using marginal structural models emulating ITT and PP trials. Results: We observed 17,004 PWH (954 cancers) with PI-based (median 6 years follow-up), 17,536 (770 cancers) with NNRTI-based (median 5 years follow-up), and 1782 (29 cancers) with INSTI-based ART (median 2 years follow-up). Analyses with 85-month follow-up indicated no cancer risk differences. In truncated analyses, the risk of ADCs (aHR 1.33; 95% CI: 1.00, 1.77 [PP analysis]) and NADCs (aHR 1.23; 95% CI: 1.00 to 1.51 [ITT analysis]) was higher comparing PIs vs. NNRTIs. Conclusions: Results with longer-term follow-up suggest being on a PI-based versus NNRTI-based ART regimen does not affect cancer risk. We observed shorter-term associations that should be interpreted cautiously and warrant further study. Further research with a longer duration of follow-up that can evaluate INSTIs, the current first-line recommended therapy, is needed to comprehensively characterize the association between ART class and cancer risk. [ABSTRACT FROM AUTHOR]

Published
2024
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163. Additional file 6 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 6. Funnel plot.

164. Additional file 4 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 4. Identified potentially eligible trials not included in the analysis.

165. Additional file 1 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
Data_FILES, 3. Good health
Abstract

Additional file 1. Search strategy.

166. Additional file 5 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 5. Risk of bias.

167. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M, Van't Hooft, Janneke, Smith, Emily R, Haber, Noah A, Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M, Alfonso, Rachelle N, Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C, Aomar, Ismael F, Argumanis, Luis E, Averyanov, Alexander, Baklaushev, Vladimir P, Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B, Bowen, Asha C, Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H, Cardesa, Ana, Carnate, Jose M, Castillo, German Jr J, Cavallo, Rossana, Chowdhury, Fazle R, Chowdhury, Forhad UH, Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M, Compernolle, Veerle, Cortez, Carlo Francisco N, Costa Neto, Abel, D'Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S, De Rosa, Francesco Giuseppe, Denholm, Justin T, Denkinger, Claudia M, Desmecht, Daniel, Díaz-Coronado, Juan C, Díaz Ponce-Medrano, Juan A, Donneau, Anne-Françoise, Dumagay, Teresita E, Dunachie, Susanna, Dungog, Cecile C, Erinoso, Olufemi, Escasa, Ivy Mae S, Estcourt, Lise J, Evans, Amy, Evasan, Agnes LM, Fareli, Christian J, Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E, Garcia, Patricia J, Garcia, Patricia L, Garcia, Jesus A, Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V, Gaviria García, Paula A, Giron-Gonzalez, Jose-Antonio, Gómez-Almaguer, David, Gordon, Anthony C, Gothot, André, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E, Harvala, Heli, Heralde, Francisco M, Herrick, Jesica, Higgins, Alisa M, Hills, Thomas E, Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M, Ivanov, Alexander V, Janssen, Maike, Jennings, Jeffrey H, Jha, Vivekanand, King, Ruby Anne N, Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-François, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-Díaz, Jorge M, López-Robles, Concepción, López-Cárdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C, Lundgren, Maria, Macías, Juan, Maganito, Sandy C, Malundo, Anna Flor G, Manrique, Rubén D, Manzini, Paola M, Marcos, Miguel, Marquez, Ignacio, Martínez-Marcos, Francisco Javier, Mata, Ana M, McArthur, Colin J, McQuilten, Zoe K, McVerry, Bryan J, Menon, David K, Meyfroidt, Geert, Mirasol, Ma Angelina L, Misset, Benoît, Molton, James S, Mondragon, Alric V, Monsalve, Diana M, Moradi Choghakabodi, Parastoo, Morpeth, Susan C, Mouncey, Paul R, Moutschen, Michel, Müller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D, Nielsen, Henrik, Novak, Richard M, O'Sullivan, Matthew VN, Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M, Patel, Mahesh C, Paterson, David L, Peña-Perez, Carlos A, Perez-Calatayud, Angel A, Pérez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J, Quero, Anne Kristine H, Rahman, Md M, Rahman, Md S, Ramesh, Mayur, Ramírez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A, Rego, Eduardo, Roberts, Jason A, Roberts, David J, Rodríguez, Yhojan, Rodríguez-Baño, Jesús, Rogers, Benjamin A, Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M, Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M, Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y, Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven YC, Turgeon, Alexis F, Veloso, Januario D, Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A, Wiese, Lothar, Wikén, Christian, Wood, Erica M, Yusubalieva, Gaukhar M, Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N, Ioannidis, John PA, and Hemkens, Lars G

Subjects
Meta-analysis, Convalescent plasma, Treatment Outcome, SARS-CoV-2, Immunization, Passive, COVID-19, Humans, COVID-19 Serotherapy, 3. Good health, Randomized Controlled Trials as Topic
Abstract

Funder: laura and john arnold foundation, BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. CONCLUSIONS: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

168. Additional file 6 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 6. Funnel plot.

169. Additional file 5 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 5. Risk of bias.

170. Additional file 2 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
TheoryofComputation_MISCELLANEOUS, InformationSystems_INFORMATIONSYSTEMSAPPLICATIONS, Data_FILES, GeneralLiterature_MISCELLANEOUS, ComputingMilieux_MISCELLANEOUS, 3. Good health
Abstract

Additional file 2. Email invitation.

171. Additional file 7 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 7. Sensitivity analyses: various meta-analytic approaches.

172. Additional file 4 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 4. Identified potentially eligible trials not included in the analysis.

173. Additional file 3 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
GeneralLiterature_INTRODUCTORYANDSURVEY, ComputerSystemsOrganization_COMPUTER-COMMUNICATIONNETWORKS, Data_FILES, ComputingMilieux_LEGALASPECTSOFCOMPUTING, 3. Good health
Abstract

Additional file 3. Amendments to the protocol.

174. Additional file 2 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
TheoryofComputation_MISCELLANEOUS, InformationSystems_INFORMATIONSYSTEMSAPPLICATIONS, Data_FILES, GeneralLiterature_MISCELLANEOUS, ComputingMilieux_MISCELLANEOUS, 3. Good health
Abstract

Additional file 2. Email invitation.

175. Additional file 7 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
3. Good health
Abstract

Additional file 7. Sensitivity analyses: various meta-analytic approaches.

176. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M, Van't Hooft, Janneke, Smith, Emily R, Haber, Noah A, Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M, Alfonso, Rachelle N, Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C, Aomar, Ismael F, Argumanis, Luis E, Averyanov, Alexander, Baklaushev, Vladimir P, Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B, Bowen, Asha C, Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H, Cardesa, Ana, Carnate, Jose M, Castillo, German Jr J, Cavallo, Rossana, Chowdhury, Fazle R, Chowdhury, Forhad UH, Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M, Compernolle, Veerle, Cortez, Carlo Francisco N, Costa Neto, Abel, D'Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S, De Rosa, Francesco Giuseppe, Denholm, Justin T, Denkinger, Claudia M, Desmecht, Daniel, D��az-Coronado, Juan C, D��az Ponce-Medrano, Juan A, Donneau, Anne-Fran��oise, Dumagay, Teresita E, Dunachie, Susanna, Dungog, Cecile C, Erinoso, Olufemi, Escasa, Ivy Mae S, Estcourt, Lise J, Evans, Amy, Evasan, Agnes LM, Fareli, Christian J, Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E, Garcia, Patricia J, Garcia, Patricia L, Garcia, Jesus A, Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V, Gaviria Garc��a, Paula A, Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C, Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E, Harvala, Heli, Heralde, Francisco M, Herrick, Jesica, Higgins, Alisa M, Hills, Thomas E, Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M, Ivanov, Alexander V, Janssen, Maike, Jennings, Jeffrey H, Jha, Vivekanand, King, Ruby Anne N, Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M, L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C, Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C, Malundo, Anna Flor G, Manrique, Rub��n D, Manzini, Paola M, Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M, McArthur, Colin J, McQuilten, Zoe K, McVerry, Bryan J, Menon, David K, Meyfroidt, Geert, Mirasol, Ma Angelina L, Misset, Beno��t, Molton, James S, Mondragon, Alric V, Monsalve, Diana M, Moradi Choghakabodi, Parastoo, Morpeth, Susan C, Mouncey, Paul R, Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D, Nielsen, Henrik, Novak, Richard M, O'Sullivan, Matthew VN, Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M, Patel, Mahesh C, Paterson, David L, Pe��a-Perez, Carlos A, Perez-Calatayud, Angel A, P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J, Quero, Anne Kristine H, Rahman, Md M, Rahman, Md S, Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A, Rego, Eduardo, Roberts, Jason A, Roberts, David J, Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A, Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M, Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M, Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y, Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven YC, Turgeon, Alexis F, Veloso, Januario D, Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A, Wiese, Lothar, Wik��n, Christian, Wood, Erica M, Yusubalieva, Gaukhar M, Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N, Ioannidis, John PA, and Hemkens, Lars G

Subjects
Meta-analysis, Convalescent plasma, SARS-CoV-2, COVID-19, 3. Good health, Research Article
Abstract

Funder: laura and john arnold foundation; doi: http://dx.doi.org/10.13039/100009827, BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. CONCLUSIONS: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

177. Additional file 3 of Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, Cathrine, Janiaud, Perrine, Schmitt, Andreas M., van���t Hooft, Janneke, Smith, Emily R., Haber, Noah A., Abayomi, Akin, Abduljalil, Manal, Abdulrahman, Abdulkarim, Acosta-Ampudia, Yeny, Aguilar-Guisado, Manuela, Al-Beidh, Farah, Alejandria, Marissa M., Alfonso, Rachelle N., Ali, Mohammad, AlQahtani, Manaf, AlZamrooni, Alaa, Anaya, Juan-Manuel, Ang, Mark Angelo C., Aomar, Ismael F., Argumanis, Luis E., Averyanov, Alexander, Baklaushev, Vladimir P., Balionis, Olga, Benfield, Thomas, Berry, Scott, Birocco, Nadia, Bonifacio, Lynn B., Bowen, Asha C., Bown, Abbie, Cabello-Gutierrez, Carlos, Camacho, Bernardo, Camacho-Ortiz, Adrian, Campbell-Lee, Sally, Cao, Damon H., Cardesa, Ana, Carnate, Jose M., Castillo, German Jr. J., Cavallo, Rossana, Chowdhury, Fazle R., Chowdhury, Forhad U. H., Ciccone, Giovannino, Cingolani, Antonella, Climacosa, Fresthel Monica M., Compernolle, Veerle, Cortez, Carlo Francisco N., Costa Neto, Abel, D���Antico, Sergio, Daly, James, Danielle, Franca, Davis, Joshua S., De Rosa, Francesco Giuseppe, Denholm, Justin T., Denkinger, Claudia M., Desmecht, Daniel, D��az-Coronado, Juan C., D��az Ponce-Medrano, Juan A., Donneau, Anne-Fran��oise, Dumagay, Teresita E., Dunachie, Susanna, Dungog, Cecile C., Erinoso, Olufemi, Escasa, Ivy Mae S., Estcourt, Lise J., Evans, Amy, Evasan, Agnes L. M., Fareli, Christian J., Fernandez-Sanchez, Veronica, Galassi, Claudia, Gallo, Juan E., Garcia, Patricia J., Garcia, Patricia L., Garcia, Jesus A., Garigliany, Mutien, Garza-Gonzalez, Elvira, Gauiran, Deonne Thaddeus V., Gaviria Garc��a, Paula A., Giron-Gonzalez, Jose-Antonio, G��mez-Almaguer, David, Gordon, Anthony C., Gothot, Andr��, Grass Guaqueta, Jeser Santiago, Green, Cameron, Grimaldi, David, Hammond, Naomi E., Harvala, Heli, Heralde, Francisco M., Herrick, Jesica, Higgins, Alisa M., Hills, Thomas E., Hines, Jennifer, Holm, Karin, Hoque, Ashraful, Hoste, Eric, Ignacio, Jose M., Ivanov, Alexander V., Janssen, Maike, Jennings, Jeffrey H., Jha, Vivekanand, King, Ruby Anne N., Kjeldsen-Kragh, Jens, Klenerman, Paul, Kotecha, Aditya, Krapp, Fiorella, Labanca, Luciana, Laing, Emma, Landin-Olsson, Mona, Laterre, Pierre-Fran��ois, Lim, Lyn-Li, Lim, Jodor, Ljungquist, Oskar, Llaca-D��az, Jorge M., L��pez-Robles, Concepci��n, L��pez-C��rdenas, Salvador, Lopez-Plaza, Ileana, Lucero, Josephine Anne C., Lundgren, Maria, Mac��as, Juan, Maganito, Sandy C., Malundo, Anna Flor G., Manrique, Rub��n D., Manzini, Paola M., Marcos, Miguel, Marquez, Ignacio, Mart��nez-Marcos, Francisco Javier, Mata, Ana M., McArthur, Colin J., McQuilten, Zoe K., McVerry, Bryan J., Menon, David K., Meyfroidt, Geert, Mirasol, Ma. Angelina L., Misset, Beno��t, Molton, James S., Mondragon, Alric V., Monsalve, Diana M., Moradi Choghakabodi, Parastoo, Morpeth, Susan C., Mouncey, Paul R., Moutschen, Michel, M��ller-Tidow, Carsten, Murphy, Erin, Najdovski, Tome, Nichol, Alistair D., Nielsen, Henrik, Novak, Richard M., O���Sullivan, Matthew V. N., Olalla, Julian, Osibogun, Akin, Osikomaiya, Bodunrin, Oyonarte, Salvador, Pardo-Oviedo, Juan M., Patel, Mahesh C., Paterson, David L., Pe��a-Perez, Carlos A., Perez-Calatayud, Angel A., P��rez-Alba, Eduardo, Perkina, Anastasia, Perry, Naomi, Pouladzadeh, Mandana, Poyato, Inmaculada, Price, David J., Quero, Anne Kristine H., Rahman, Md. M., Rahman, Md. S., Ramesh, Mayur, Ram��rez-Santana, Carolina, Rasmussen, Magnus, Rees, Megan A., Rego, Eduardo, Roberts, Jason A., Roberts, David J., Rodr��guez, Yhojan, Rodr��guez-Ba��o, Jes��s, Rogers, Benjamin A., Rojas, Manuel, Romero, Alberto, Rowan, Kathryn M., Saccona, Fabio, Safdarian, Mehdi, Santos, Maria Clariza M., Sasadeusz, Joe, Scozzari, Gitana, Shankar-Hari, Manu, Sharma, Gorav, Snelling, Thomas, Soto, Alonso, Tagayuna, Pedrito Y., Tang, Amy, Tatem, Geneva, Teofili, Luciana, Tong, Steven Y. C., Turgeon, Alexis F., Veloso, Januario D., Venkatesh, Balasubramanian, Ventura-Enriquez, Yanet, Webb, Steve A., Wiese, Lothar, Wik��n, Christian, Wood, Erica M., Yusubalieva, Gaukhar M., Zacharowski, Kai, Zarychanski, Ryan, Khanna, Nina, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.

Subjects
GeneralLiterature_INTRODUCTORYANDSURVEY, ComputerSystemsOrganization_COMPUTER-COMMUNICATIONNETWORKS, Data_FILES, ComputingMilieux_LEGALASPECTSOFCOMPUTING, 3. Good health
Abstract

Additional file 3. Amendments to the protocol.

179. Maternal COVID-19 Vaccination and Prevention of Symptomatic Infection in Infants.

Author

Cardemil, Cristina V., Yi Cao, Posavad, Christine M., Badell, Martina L., Bunge, Katherine, Mulligan, Mark J., Parameswaran, Lalitha, Olson-Chen, Courtney, Novak, Richard M., Brady, Rebecca C., DeFranco, Emily, Gerber, Jeffrey S., Pasetti, Marcela, Shriver, Mallory, Coler, Rhea, Berube, Bryan, Suthar, Mehul S., Moreno, Alberto, Fei Gao, and Richardson, Barbra A.

Subjects
*IMMUNIZATION, *IMMUNOGLOBULINS, *CONFIDENCE intervals, *CLINICAL trials, *COVID-19 vaccines, *INFECTION control, *VACCINE effectiveness, *MESSENGER RNA, *DESCRIPTIVE statistics, *RESEARCH funding, *VIRAL antibodies, *PREGNANCY
Abstract

Background and objectives: Maternal vaccination may prevent infant coronavirus disease 2019 (COVID-19). We aimed to quantify protection against infection from maternally derived vaccine-induced antibodies in the first 6 months of an infant's life. Methods: Infants born to mothers vaccinated during pregnancy with 2 or 3 doses of a messenger RNA COVID-19 vaccine (nonboosted or boosted, respectively) had full-length spike (Spike) immunoglobulin G (IgG), pseudovirus 614D, and live virus D614G, and omicron BA.1 and BA.5 neutralizing antibody (nAb) titers measured at delivery. Infant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was determined by verified maternal-report and laboratory confirmation through prospective follow-up to 6 months of age between December 2021 and July 2022. The risk reduction for infection by dose group and antibody titer level was estimated in separate models. Results: Infants of boosted mothers (n = 204) had significantly higher Spike IgG, pseudovirus, and live nAb titers at delivery than infants of nonboosted mothers (n = 271), and were 56% less likely to acquire infection in the first 6 months (P = .03). Irrespective of boost, for each 10-fold increase in Spike IgG titer at delivery, the infant's risk of acquiring infection was reduced by 47% (95% confidence interval 8%-70%; P = .02). Similarly, a 10-fold increase in pseudovirus titers against Wuhan Spike, and live virus nAb titers against D614G, and omicron BA.1 and BA.5 at delivery were associated with a 30%, 46%, 56%, and 60% risk reduction, respectively. Conclusions: Higher transplacental binding and nAb titers substantially reduced the risk of SARS-CoV-2 infection in infants, and a booster dose amplified protection during a period of omicron predominance. Until infants are age-eligible for vaccination, maternal vaccination provides passive protection against symptomatic infection during early infancy. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

180. Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

Author

Rouphael, Nadine G, Branche, Angela R, Diemert, David J, Falsey, Ann R, Losada, Cecilia, Baden, Lindsey R, Frey, Sharon E, Whitaker, Jennifer A, Little, Susan J, Kamidani, Satoshi, Walter, Emmanuel B, Novak, Richard M, Rupp, Richard, Jackson, Lisa A, Babu, Tara M, Kottkamp, Angelica C, Luetkemeyer, Anne F, Immergluck, Lilly C, Presti, Rachel M, and Bäcker, Martín

Subjects
*CLINICAL trials, *SARS-CoV-2 Omicron variant, *IMMUNE response, *VACCINES, *MESSENGER RNA
Abstract

We compared the serologic responses of 1 dose versus 2 doses of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with a variant vaccine did not increase the magnitude or the durability of the serological responses compared to a single variant vaccine boost. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

181. Feasibility of Universal HIV Testing in an Outpatient Clinic.

Author

Turin, Sergey Y., Rosenfield, Rachel E., Lee, Melody, Patel, Krishna, and Novak, Richard M.

Subjects
DIAGNOSIS of HIV infections, ENZYME-linked immunosorbent assay, HIV-positive persons, HIV infections -- Social aspects, DIAGNOSIS
Abstract

The article discusses a study on feasibility of a universal opt-in rapid HIV testing protocol in the Internal Medicine outpatient care clinic of the University of Illinois at Chicago, Illinois. The topics discussed include removal of social stigma associated with HIV infections, use of enzyme-linked immunosorbent assay (ELISA) test based on a blood sample obtained by finger-stick, and participants' willingness to undergo HIV test.

Published
2014
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182. Incidence of Hyperlipidemia among Adults Initiating Antiretroviral Therapy in the HIV Outpatient Study (HOPS), USA, 2007–2021.

Author

Li, Jun, Agbobli-Nuwoaty, Selom, Palella, Frank J., Novak, Richard M., Tedaldi, Ellen, Mayer, Cynthia, Mahnken, Jonathan D., Hou, Qingjiang, Carlson, Kimberly, Thompson-Paul, Angela M., Durham, Marcus D., and Buchacz, Kate

Subjects
*ANTIRETROVIRAL agents, *HYPERLIPIDEMIA, *ADULTS, *HIV, *POISSON regression
Abstract

Current U.S. guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) as initial treatment for people with HIV (PWH). We assessed long-term effects of INSTI use on lipid profiles in routine HIV care. We analyzed medical record data from the HIV Outpatient Study's participants in care from 2007 to 2021. Hyperlipidemia was defined based on clinical diagnoses, treatments, and laboratory results. We calculated hyperlipidemia incidence rates and rate ratios (RRs) during initial ART and assessed predictors of incident hyperlipidemia by using Poisson regression. Among 349 eligible ART-naïve PWH, 168 were prescribed INSTI-based ART (36 raltegravir (RAL), 51 dolutegravir (DTG), and 81 INSTI-others (elvitegravir and bictegravir)) and 181 non-INSTI-based ART, including 68 protease inhibitor (PI)-based ART. During a median follow-up of 1.4 years, hyperlipidemia rates were 12.8, 22.3, 22.7, 17.4, and 12.6 per 100 person years for RAL-, DTG-, INSTI-others-, non-INSTI-PI-, and non-INSTI-non-PI-based ART, respectively. In multivariable analysis, compared with the RAL group, hyperlipidemia rates were higher in INSTI-others (RR = 2.25; 95% confidence interval (CI): 1.29–3.93) and non-INSTI-PI groups (RR = 1.89; CI: 1.12–3.19) but not statistically higher for the DTG (RR = 1.73; CI: 0.95–3.17) and non-INSTI-non-PI groups (RR = 1.55; CI: 0.92–2.62). Other factors independently associated with hyperlipidemia included older age, non-Hispanic White race/ethnicity, and ART without tenofovir disoproxil fumarate. PWH using RAL-based regimens had lower rates of incident hyperlipidemia than PWH receiving non-INSTI-PI-based ART but had similar rates as those receiving DTG-based ART, supporting federal recommendations for using DTG-based regimens as the initial therapy for ART-naïve PWH. [ABSTRACT FROM AUTHOR]

Published
2023
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183. COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn.

Author

Munoz, Flor M., Posavad, Christine M., Richardson, Barbra A., Badell, Martina L., Bunge, Katherine E., Mulligan, Mark J., Parameswaran, Lalitha, Kelly, Clifton W., Olson-Chen, Courtney, Novak, Richard M., Brady, Rebecca C., Pasetti, Marcela F., Defranco, Emily A., Gerber, Jeffrey S., Shriver, Mallory C., Suthar, Mehul S., Coler, Rhea N., Berube, Bryan J., Kim, So Hee, and Piper, Jeanna M.

Subjects
*BOOSTER vaccines, *MATERNALLY acquired immunity, *COVID-19 vaccines, *ANTIBODY formation, *SARS-CoV-2 Omicron variant, *CORD blood
Abstract

• Data are needed to understand responses to primary and booster COVID-19 vaccinations during pregnancy. • mRNA vaccines during pregnancy elicited robust binding and nAb responses. • Booster vaccination during pregnancy elicited significantly higher Ab levels at delivery and in cord blood than 2-dose primary series, including against Delta and Omicron BA.1 variants. • COVID-19 vaccines, including booster doses, should continue to be strongly recommended during pregnancy. The immune response to COVID-19 booster vaccinations during pregnancy for mothers and their newborns and the functional response of vaccine-induced antibodies against Omicron variants are not well characterized. We conducted a prospective, multicenter cohort study of participants vaccinated during pregnancy with primary or booster mRNA COVID-19 vaccines from July 2021 to January 2022 at 9 academic sites. We determined SARS-CoV-2 binding and live virus and pseudovirus neutralizing antibody (nAb) titers pre- and post-vaccination, and at delivery for both maternal and infant participants. Immune responses to ancestral and Omicron BA.1 SARS-CoV-2 strains were compared between primary and booster vaccine recipients in maternal sera at delivery and in cord blood, after adjusting for days since last vaccination. A total of 240 participants received either Pfizer or Moderna mRNA vaccine during pregnancy (primary 2-dose series: 167; booster dose: 73). Booster vaccination resulted in significantly higher binding and nAb titers, including to the Omicron BA.1 variant, in maternal serum at delivery and in cord blood compared to a primary 2-dose series (range 0.44–0.88 log 10 higher, p < 0.0001 for all comparisons). Live virus nAb to Omicron BA.1 were present at delivery in 9 % (GMT ID50 12.7) of Pfizer and 22 % (GMT ID50 14.7) of Moderna primary series recipients, and in 73 % (GMT ID50 60.2) of mRNA boosted participants (p < 0.0001), although titers were significantly lower than to the D614G strain. Transplacental antibody transfer was efficient for all regimens with median transfer ratio range: 1.55–1.77 for IgG, 1.00–1.78 for live virus nAb and 1.79–2.36 for pseudovirus nAb. COVID-19 mRNA vaccination during pregnancy elicited robust immune responses in mothers and efficient transplacental antibody transfer to the newborn. A booster dose during pregnancy significantly increased maternal and cord blood binding and neutralizing antibody levels, including against Omicron BA.1. Findings support the use of a booster dose of COVID-19 vaccine during pregnancy. [ABSTRACT FROM AUTHOR]

Published
2023
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184. Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial.

Author

Branche, Angela R, Rouphael, Nadine G, Losada, Cecilia, Baden, Lindsey R, Anderson, Evan J, Luetkemeyer, Anne F, Diemert, David J, Winokur, Patricia L, Presti, Rachel M, Kottkamp, Angelica C, Falsey, Ann R, Frey, Sharon E, Rupp, Richard, Bäcker, Martín, Novak, Richard M, Walter, Emmanuel B, Jackson, Lisa A, Little, Susan J, Immergluck, Lilly C, and Mahgoub, Siham M

Subjects
*IMMUNOGLOBULIN analysis, *CONFIDENCE intervals, *COVID-19 vaccines, *CORONAVIRUS spike protein, *CHRONIC diseases, *CHEMILUMINESCENCE assay, *VACCINE immunogenicity, *VACCINE effectiveness, *ANTIBODY formation, *RANDOMIZED controlled trials, *MESSENGER RNA, *DESCRIPTIVE statistics, *RESEARCH funding, *STATISTICAL sampling, *POLYMERASE chain reaction
Abstract

In a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein combined with wild-type spike. Responses against SARS-CoV-2 variants exhibited the greatest reduction in titers against currently circulating Omicron subvariants for both bivalent vaccines. [ABSTRACT FROM AUTHOR]

Published
2023
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185. Mycobacterium conceptionense Pneumonitis in Patient with HIV/AIDS1.

Author

Michienzi, Sarah M., Burgos, Rodrigo M., and Novak, Richard M.

Subjects
*ANTIBIOTICS, *MYCOBACTERIAL disease diagnosis, *COMBINATION drug therapy, *GRAM-positive bacteria, *MYCOBACTERIAL diseases, *PNEUMONIA, *AZITHROMYCIN, *AIDS-related opportunistic infections, *HIGHLY active antiretroviral therapy, *DOXYCYCLINE
Abstract

Approximately 21 human cases of infection with Mycobacterium conceptionense have been reported. However, most cases were outside the United States, and optimal treatment remains uncertain. We report a case of M. conceptionense pneumonitis in a patient with HIV/AIDS in the United States. The patient was cured with azithromycin and doxycycline. [ABSTRACT FROM AUTHOR]

Published
2019
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186. Kinetics of the Antibody Response to Symptomatic SARS-CoV-2 Infection in Vaccinated and Unvaccinated Individuals in the Blinded Phase of the mRNA-1273 COVID-19 Vaccine Efficacy Trial.

Author

Follmann, Dean, Janes, Holly E, Chu, Eric, Jayashankar, Lakshmi, Petropoulos, Christos J, Serebryannyy, Leonid, Carroll, Robin, Jean-Baptiste, Naz, Narpala, Sandeep, Lin, Bob C, McDermott, Adrian, Novak, Richard M, Graciaa, Daniel S, Rolsma, Stephanie, Magaret, Craig A, Doria-Rose, Nicole, Corey, Lawrence, Neuzil, Kathleen M, Pajon, Rolando, and Miller, Jacqueline M

Abstract

Background Hybrid immunity is associated with more durable protection against coronavirus disease 2019 (COVID-19). We describe the antibody responses following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vaccinated and unvaccinated individuals. Methods The 55 vaccine arm COVID-19 cases diagnosed during the blinded phase of the Coronavirus Efficacy trial were matched with 55 placebo arm COVID-19 cases. Pseudovirus neutralizing antibody (nAb) activity to the ancestral strain and binding antibody (bAb) responses to nucleocapsid and spike antigens (ancestral and variants of concern [VOCs]) were assessed on disease day 1 (DD1) and 28 days later (DD29). Results The primary analysis set was 46 vaccine cases and 49 placebo cases with COVID-19 at least 57 days post–first dose. For vaccine group cases, there was a 1.88-fold rise in ancestral antispike bAbs 1 month post–disease onset, although 47% had no increase. The vaccine-to-placebo geometric mean ratios for DD29 antispike and antinucleocapsid bAbs were 6.9 and 0.04, respectively. DD29 mean bAb levels were higher for vaccine vs placebo cases for all VOCs. DD1 nasal viral load positively correlated with bAb levels in the vaccine group. Conclusions Following COVID-19, vaccinated participants had higher levels and greater breadth of antispike bAbs and higher nAb titers than unvaccinated participants. These were largely attributable to the primary immunization series. [ABSTRACT FROM AUTHOR]

Published
2023
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187. Clinical Pharmacokinetics of Daptomycin

Author

Pryka, Randy D., Novak, Richard M., Wagner, David K., and Rodvold, Keith A.

Abstract

Daptomycin is a new lipopeptide antibiotic for which preliminary pharmacokinetic data in adults have been limited to normal healthy volunteers and patients with renal insufficiency. We report the clinical pharmacokinetics of the first and fifth doses of iv daptomycin 150 mg (2 mg/kg) q24h in a 29-year-old man being treated for a gram-positive cellulitis and thrombophlebitis. Individual pharmacokinetic parameters yielded similar results during doses one and five. The pharmacokinetic profile observed in our patient did not markedly differ from data obtained from healthy volunteers.

Published
1990
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188. CD4/CD8 Ratio and Cancer Risk Among Adults With HIV.

Author

Castilho, Jessica L, Bian, Aihua, Jenkins, Cathy A, Shepherd, Bryan E, Sigel, Keith, Gill, M John, Kitahata, Mari M, Silverberg, Michael J, Mayor, Angel M, Coburn, Sally B, Wiley, Dorothy, Achenbach, Chad J, Marconi, Vincent C, Bosch, Ronald J, Horberg, Michael A, Rabkin, Charles S, Napravnik, Sonia, Novak, Richard M, Mathews, W Christopher, and Thorne, Jennifer E

Subjects
*HIV infection epidemiology, *HIV infection complications, *LUNG tumors, *KAPOSI'S sarcoma, *ANAL tumors, *CD4 lymphocyte count, *RESEARCH funding, *T cells, *NON-Hodgkin's lymphoma, *AIDS
Abstract

Background: Independent of CD4 cell count, a low CD4/CD8 ratio in people with HIV (PWH) is associated with deleterious immune senescence, activation, and inflammation, which may contribute to carcinogenesis and excess cancer risk. We examined whether low CD4/CD8 ratios predicted cancer among PWH in the United States and Canada.Methods: We examined all cancer-free PWH with 1 or more CD4/CD8 values from North American AIDS Cohort Collaboration on Research and Design observational cohorts with validated cancer diagnoses between 1998 and 2016. We evaluated the association between time-lagged CD4/CD8 ratio and risk of specific cancers in multivariable, time-updated Cox proportional hazard models using restricted cubic spines. Models were adjusted for age, sex, race and ethnicity, hepatitis C virus, and time-updated CD4 cell count, HIV RNA, and history of AIDS-defining illness.Results: Among 83 893 PWH, there were 5628 incident cancers, including lung cancer (n = 755), Kaposi sarcoma (n = 501), non-Hodgkin lymphoma (n = 497), and anal cancer (n = 439). The median age at cohort entry was 43 years. The overall median 6-month lagged CD4/CD8 ratio was 0.52 (interquartile range = 0.30-0.82). Compared with a 6-month lagged CD4/CD8 of 0.80, a CD4/CD8 of 0.30 was associated with increased risk of any incident cancer (adjusted hazard ratio = 1.24 [95% confidence interval = 1.14 to 1.35]). The CD4/CD8 ratio was also inversely associated with non-Hodgkin lymphoma, Kaposi sarcoma, lung cancer, anal cancer, and colorectal cancer in adjusted analyses (all 2-sided P < .05). Results were similar using 12-, 18-, and 24-month lagged CD4/CD8 values.Conclusions: A low CD4/CD8 ratio up to 24 months before cancer diagnosis was independently associated with increased cancer risk in PWH and may serve as a clinical biomarker. [ABSTRACT FROM AUTHOR]

Published
2022
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189. Sexually Transmitted Disease Testing of Human Immunodeficiency Virus-Infected Men Who Have Sex With Men: Room for Improvement.

Author

Dean, Bonnie B., Scott, Mia, Hart, Rachel, Battalora, Linda, Novak, Richard M., Durham, Marcus D., Brooks, John T., Buchacz, Kate, and HIV Outpatient Study (HOPS) Investigators

Subjects
*DIAGNOSIS of bacterial diseases, *DIAGNOSIS of HIV infections, *SEXUALLY transmitted disease diagnosis, *EPIDEMIOLOGY of sexually transmitted diseases, *HIV infection epidemiology, *BACTERIAL diseases, *ETHNIC groups, *HOMOSEXUALITY, *LONGITUDINAL method, *MEDICAL screening, *METROPOLITAN areas, *RISK assessment, *VIRAL load, *PATIENTS' attitudes, *SEXUAL partners, *CD4 lymphocyte count, *MIXED infections, *DIAGNOSIS
Abstract

Background: In the United States, sexually transmitted infection (STI) testing is recommended at least annually for sexually active men who have sex with men (MSM). We evaluated human immunodeficiency virus (HIV) providers' STI testing practices and frequency of positive test results.Methods: We analyzed data from HIV Outpatient Study (HOPS) participants who, from 2007 to 2014, completed a confidential survey about risk behaviors. Using medical records data, we assessed the frequency of gonorrhea, chlamydia, and syphilis testing and positive results during the year after the survey for MSM who reported sex without a condom in the prior 6 months. We compared testing frequency and positivity for men having 1, 2 to 3, and 4 or more sexual partners. Correlates of STI testing were assessed using general linear model to derive relative risks (RR) with associated 95% confidence intervals (CI).Results: Among 719 MSM, testing frequency was 74.5%, 74.3%, and 82.9% for gonorrhea, chlamydia, and syphilis, respectively, and was higher in those men who reported more sexual partners (P < 0.001 for all). In multivariable analysis, testing for gonorrhea was significantly more likely among non-Hispanic black versus white men (RR, 1.17; 95% CI, 1.03-1.33), among men seen in private versus public clinics (RR, 1.16; 95% CI, 1.05-1.28), and among men with 2 to 3 and 4 or more sexual partners versus 1 partner (RR, 1.12; 95% CI, 1.02-1.23, and RR, 1.18; 95% CI, 1.08-1.30, respectively). Correlates of chlamydia and syphilis testing were similar. Test positivity was higher among men with more sexual partners: for gonorrhea 0.0%, 3.0%, and 6.7% for men with 1, 2 to 3, and 4 or more partners, respectively (P < 0.001, syphilis 3.7%, 3.8% and 12.5%, P < 0.001).Conclusions: Among HIV-infected MSM patients in HIV care who reported sex without a condom, subsequent testing was not documented in clinic records during the following year for up to a quarter of patients. Exploring why STI testing did not occur may improve patient care. [ABSTRACT FROM AUTHOR]

Published
2017
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190. Microbiome Composition and Function Drives Wound-Healing Impairment in the Female Genital Tract.

Author

Zevin, Alexander S., Xie, Irene Y., Birse, Kenzie, Arnold, Kelly, Romas, Laura, Westmacott, Garrett, Novak, Richard M., McCorrister, Stuart, McKinnon, Lyle R., Cohen, Craig R., Mackelprang, Romel, Lingappa, Jairam, Lauffenburger, Doug A., Klatt, Nichole R., and Burgener, Adam D.

Subjects
*HUMAN microbiota, *WOUND healing, *GENITALIA, *BACTERIAL vaginitis, *DISEASE prevalence, *WOUNDS & injuries
Abstract

The mechanism(s) by which bacterial communities impact susceptibility to infectious diseases, such as HIV, and maintain female genital tract (FGT) health are poorly understood. Evaluation of FGT bacteria has predominantly been limited to studies of species abundance, but not bacterial function. We therefore sought to examine the relationship of bacterial community composition and function with mucosal epithelial barrier health in the context of bacterial vaginosis (BV) using metaproteomic, metagenomic, and in vitro approaches. We found highly diverse bacterial communities dominated by Gardnerella vaginalis associated with host epithelial barrier disruption and enhanced immune activation, and low diversity communities dominated by Lactobacillus species that associated with lower Nugent scores, reduced pH, and expression of host mucosal proteins important for maintaining epithelial integrity. Importantly, proteomic signatures of disrupted epithelial integrity associated with G. vaginalis-dominated communities in the absence of clinical BV diagnosis. Because traditional clinical assessments did not capture this, it likely represents a larger underrepresented phenomenon in populations with high prevalence of G. vaginalis. We finally demonstrated that soluble products derived from G. vaginalis inhibited wound healing, while those derived from L. iners did not, providing insight into functional mechanisms by which FGT bacterial communities affect epithelial barrier integrity. [ABSTRACT FROM AUTHOR]

Published
2016
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191. Higher Levels of CRP, D-dimer, IL-6, and Hyaluronic Acid Before Initiation of Antiretroviral Therapy (ART) Are Associated With Increased Risk of AIDS or Death.

Author

Boulware, David R., Hullsiek, Katherine Huppler, Puronen, Camille E., Rupert, Adam, Baker, Jason V., French, Martyn A., Bohjanen, Paul R., Novak, Richard M., Neaton, James D., and Sereti, Irini

Abstract

Background. Substantial morbidity occurs during the first year of antiretroviral therapy (ART) in persons with advanced human immunodeficiency virus (HIV) disease despite HIV suppression. Biomarkers may identify high-risk groups.Methods. Pre-ART and 1-month samples from an initial ART trial were evaluated for biomarkers associated with AIDS events or death within 1–12 months. Case patients (n = 63) and control patients (n = 126) were 1:2 matched on baseline CD4 cell count, hepatitis status, and randomization date. All had ≥1 log10 HIV RNA level decrease at 1 month.Results. Case patients had more frequent prior AIDS events, compared with control patients (P = .004), but similar HIV RNA levels at baseline. Pre-ART and 1-month C-reactive protein (CRP), D-dimer, and interleukin 6 (IL-6) levels and pre-ART hyaluronic acid (HA) levels were associated with new AIDS events or death (P ≤ .01). Patients who experienced immune reconstitution inflammatory syndrome (IRIS) events had higher pre-ART tumor necrosis factor α (TNF-α) and HIV RNA levels and significant 1-month increases in CRP, D-dimer, IL-6, interleukin 8, CXCL10, TNF-α, and interferon-γ levels, compared with patients who experienced non-IRIS events (P ≤ .03). Individuals with baseline CRP and HA levels above the cohort median (>2.1 mg/L and >50.0 ng/mL, respectively) had increased risk of AIDS or death (OR, 4.6 [95% CI, 2.0–10.3]; P < .001) and IRIS (OR, 8.7 [95% CI, 2.2–34.8] P = .002).Conclusions. Biomarkers of Inflammation (CRP, IL-6), coagulation (D-dimer), and tissue fibrosis (HA) measured pre-ART and at 1 month are associated with higher risk of AIDS events, IRIS, or death, warranting additional study as risk stratification strategies. [ABSTRACT FROM PUBLISHER]

Published
2011
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192. Policosanol for managing human immunodeficiency virus-related dyslipidemia in a medically underserved population: a randomized, controlled clinical trial.

Author

Swanson B, Keithley JK, Sha BE, Fogg L, Nerad J, Novak RM, Adeyemi O, Spear GT, Swanson, Barbara, Keithley, Joyce K, Sha, Beverly E, Fogg, Louis, Nerad, Judith, Novak, Richard M, Adeyemi, Oluwatoyin, and Spear, Gregory T

Abstract

Background: Human immunodeficiency virus (HIV) infection is associated with dyslipidemia and increased risk for cardiovascular events; however, the use ofstatins in HIV-infected people is complicated by pharmacokinetic interactions and overlapping toxicities with antiretroviral medications. Policosanol is a dietary supplement derived from sugar cane that is widely used as a statin alternative in Latin America.Primary Study Objective: To collect feasibility data on sugar cane-derived policosanol to normalize dyslipidemic profiles in a sample of medically underserved HIV-infected people.Methods/design: Randomized, controlled, double-blind clinical trial.Setting: Two infectious disease outpatient clinics located in a Health Resources Service Administration-designated medically underserved neighborhood in Chicago, Illinois.Participants: Fifty-four clinically stable HIV-infected people (91% black) with at least one lipid abnormality that warranted dietary modifications and/or drug therapy.Intervention: Participants received either 20 mg/day of policosanol or placebo for 12 weeks, followed by a 4-week washout and crossover to the other arm.Primary Outcome Measures: Efficacy measures included the standard lipid panel (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) and nuclear magnetic resonance (NMR)-derived lipoprotein particle profiles. Safety measures included CD4+ T lymphocyte counts, plasma HIV ribonucleic acid levels, serum creatinine, and liver function tests.Results: Policosanol supplementation was not associated with normalization of any dyslipidemic parameters as measured by the standard lipid panel or NMR spectroscopy-measured lipoprotein size or concentration. The supplement was well tolerated and was not associated with any changes in parameters of HIV disease progression.Conclusions: Our findings corroborate recent studies conducted outside Cuba that have failed to find any lipid modulatory effects for policosanol. [ABSTRACT FROM AUTHOR]

Published
2011

193. Rates of suicidal ideation among HIV-infected patients in care in the HIV Outpatient Study 2000-2017, USA.

Author

Durham, Marcus D., Armon, Carl, Mahnken, Jonathan D., Novak, Richard M., Palella, Frank J., Tedaldi, Ellen, Buchacz, Kate, Palella, Frank J Jr, and HOPS Investigators

Subjects
*SUICIDAL ideation, *OUTPATIENT medical care, *ALCOHOLISM, *HIV-positive persons, *DRUG overdose
Abstract

Background: Suicidal ideation (SI) refers to an individual thinking about, considering or planning suicide. Identifying and characterizing persons with HIV (PWH) at greater risk for SI may lead to better suicide prevention strategies and quality of life improvement.Methods: Using clinical data gathered from medical chart abstraction for HIV Outpatient Study (HOPS) participants from 2000 to 2017, we assessed SI frequency among PWH in care and explored factors associated with the presence of SI diagnoses using linear mixed models analyses.Results: Among 6706 participants, 224 (3.3%) had a charted diagnosis of SI. Among those with SI, median age (interquartile range [IQR]) was 43.4 years [IQR: 38.7-50.3], median (IQR) CD4+ cell count was 439 cells/mm3 (IQR: 237-686), 71.4% were male, 54% were men who have sex with men (MSM), 25.4% heterosexual, and 13.4% persons who inject drugs. In multivariable analysis, persons at increased risk for SI were more likely to be: <50 years old (adjusted rate ratio [aRR] 1.86, 95% confidence interval [95%CI] 1.36-2.53), non-Hispanic/Latino black (aRR 1.75; 95%CI 1.29-2.38), have CD4+ cell count <350 cells/mm3 (aRR 1.32; 95%CI 1.05-1.65), have a viral load ≥50 copies/mL (aRR 1.49; 95%CI 1.12-1.98), have stopped antiretroviral therapy (aRR 1.46; 95%CI 1.10-1.95), have a history of: alcohol dependence (aRR 2.75; 95%CI 1.67-4.52), and drug overdose (aRR 4.09; 95%CI 2.16-7.71).Conclusion: Routine mental health assessment and monitoring are needed in HIV clinical practice to better understand factors associated with SI and to inform the development of preventive interventions. [ABSTRACT FROM AUTHOR]

Published
2020
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195. Neutralizing Antibody Immune Correlates for a Recombinant Protein Vaccine in the COVAIL Trial.

Author

Fong Y, Dang L, Zhang B, Fintzi J, Chen S, Wang J, Rouphael NG, Branche AR, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Yu C, Magaret CA, Molitor C, Borate B, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Mu J, Makowski M, Makhene MK, Nayak SU, Roberts PC, Follmann D, and Gilbert PB

Abstract

For COVAIL recipients of a COVID-19 Sanofi booster vaccine, neutralizing antibody titers were assessed as a correlate of risk (CoR) of COVID-19. Peak and exposure-proximal titers were inverse CoRs with covariate-adjusted hazard ratios (95% confidence intervals) 0.30 (0.11, 0.78) and 0.25 (0.07, 0.85) per 10-fold increase in weighted average titer., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Published
2024
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196. Altered transcriptomic immune responses of maintenance hemodialysis patients to the COVID-19 mRNA vaccine.

Author

Chang YS, Huang K, Lee JM, Vagts CL, Ascoli C, Amin MR, Ghassemi M, Lora CM, Edafetanure-Ibeh R, Huang Y, Cherian RA, Sarup N, Warpecha SR, Hwang S, Goel R, Turturice BA, Schott C, Hernandez M, Chen Y, Jorgensen J, Wang W, Rasic M, Novak RM, Finn PW, and Perkins DL

Subjects
Humans, Male, Female, Middle Aged, Aged, Transcriptome, Spike Glycoprotein, Coronavirus immunology, Spike Glycoprotein, Coronavirus genetics, Antibodies, Neutralizing blood, Antibodies, Neutralizing immunology, Immunoglobulin G blood, mRNA Vaccines immunology, Vaccination, Renal Dialysis, COVID-19 immunology, COVID-19 prevention & control, BNT162 Vaccine immunology, BNT162 Vaccine administration & dosage, COVID-19 Vaccines immunology, COVID-19 Vaccines administration & dosage, Antibodies, Viral blood, SARS-CoV-2 immunology, SARS-CoV-2 genetics, Kidney Failure, Chronic immunology
Abstract

Background: End-stage renal disease (ESRD) patients experience immune compromise characterized by complex alterations of both innate and adaptive immunity, and results in higher susceptibility to infection and lower response to vaccination. This immune compromise, coupled with greater risk of exposure to infectious disease at hemodialysis (HD) centers, underscores the need for examination of the immune response to the COVID-19 mRNA-based vaccines., Methods: The immune response to the COVID-19 BNT162b2 mRNA vaccine was assessed in 20 HD patients and cohort-matched controls. RNA sequencing of peripheral blood mononuclear cells was performed longitudinally before and after each vaccination dose for a total of six time points per subject. Anti-spike antibody levels were quantified prior to the first vaccination dose (V1D0) and 7 d after the second dose (V2D7) using anti-spike IgG titers and antibody neutralization assays. Anti-spike IgG titers were additionally quantified 6 mo after initial vaccination. Clinical history and lab values in HD patients were obtained to identify predictors of vaccination response., Results: Transcriptomic analyses demonstrated differing time courses of immune responses, with prolonged myeloid cell activity in HD at 1 wk after the first vaccination dose. HD also demonstrated decreased metabolic activity and decreased antigen presentation compared to controls after the second vaccination dose. Anti-spike IgG titers and neutralizing function were substantially elevated in both controls and HD at V2D7, with a small but significant reduction in titers in HD groups (p<0.05). Anti-spike IgG remained elevated above baseline at 6 mo in both subject groups. Anti-spike IgG titers at V2D7 were highly predictive of 6-month titer levels. Transcriptomic biomarkers after the second vaccination dose and clinical biomarkers including ferritin levels were found to be predictive of antibody development., Conclusions: Overall, we demonstrate differing time courses of immune responses to the BTN162b2 mRNA COVID-19 vaccination in maintenance HD subjects comparable to healthy controls and identify transcriptomic and clinical predictors of anti-spike IgG titers in HD. Analyzing vaccination as an in vivo perturbation, our results warrant further characterization of the immune dysregulation of ESRD., Funding: F30HD102093, F30HL151182, T32HL144909, R01HL138628. This research has been funded by the University of Illinois at Chicago Center for Clinical and Translational Science (CCTS) award UL1TR002003., Competing Interests: YC, KH, JL, CV, CA, MA, MG, CL, RE, YH, RC, NS, SW, SH, RG, BT, CS, MH, YC, JJ, WW, MR, PF, DP No competing interests declared, RN Received a grant from Janssen. The author has received consulting fees from Gilead and Viiv. The author has no other competing interests to declare, (© 2024, Chang, Huang et al.)

Published
2024
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197. From Acute Infection to Prolonged Health Consequences: Understanding Health Disparities and Economic Implications in Long COVID Worldwide.

Author

Sweis JJG, Alnaimat F, Esparza V, Prasad S, Azam A, Modi Z, Al-Awqati M, Jetanalin P, Sweis NJ, Ascoli C, Novak RM, Rubinstein I, Papanikolaou IC, and Sweiss N

Subjects
Humans, Pandemics, SARS-CoV-2, Health Inequities, Post-Acute COVID-19 Syndrome, COVID-19 epidemiology
Abstract

The COVID-19 pandemic has resulted in a growing number of patients experiencing persistent symptoms and physiological changes after recovering from acute SARS-CoV-2 infection, known as Long COVID. Long COVID is characterized by recurring symptoms and inflammation across multiple organ systems. Diagnosis can be challenging, influenced by factors like demographics, comorbidities, and immune responses. Long COVID impacts various organ systems and can have neuropsychological effects. Health disparities, particularly related to race, contribute to a higher burden of infection and ongoing symptoms in minority populations. Managing Long COVID entails addressing a spectrum of symptoms that encompass physical, cognitive, and psychological aspects. The recovery period for patients with Long COVID can vary significantly, influenced by factors like the severity of the disease, hospitalization, comorbidities, and age. Currently, there are no universally effective treatments, although certain interventions show promise, necessitating further research. Self-management and rehabilitation programs can provide relief, but more research is needed to establish their effectiveness. Preventive measures such as vaccination and the use of antiviral medications and metformin. It is imperative to conduct further research to develop evidence-based guidelines and gain a better understanding of the long-term implications of COVID-19. Long COVID could have substantial economic impact on the labor market, productivity, healthcare expenditures, and overall economic growth. To address the challenges patients with long-term complications face, there is a focus on strategies like promoting telework and flexible work arrangements to accommodate diverse symptoms, particularly chronic fatigue and other Long COVID effects. In conclusion, this review emphasizes the multifaceted complexity of Long COVID and the ongoing need to address its potential long-term health and economic impacts.

Published
2024
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198. Vaccination in the Era of Immunosuppression.

Author

Alnaimat F, Sweis JJG, Jansz J, Modi Z, Prasad S, AbuHelal A, Vagts C, Hanson HA, Ascoli C, Novak RM, Papanikolaou IC, Rubinstein I, and Sweiss N

Abstract

Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for severe infections. Vaccine responses and safety profiles may differ between AIIRD patients and the general population. While patients with autoimmune inflammatory rheumatic diseases (AIIRDs) often experience diminished humoral responses and reduced vaccine efficacy, factors such as the type of immunosuppressant medications used and the specific vaccine employed contribute to these outcomes. Notably, individuals undergoing B cell depletion therapy tend to have poor vaccine immunogenicity. However, despite these considerations, vaccine responses are generally considered clinically sufficient. Ideally, immunosuppressed AIIRD patients should receive vaccinations at least two weeks before commencing immunosuppressive treatment. However, it is common for many patients to already be on immunosuppressants during the immunization process. Vaccination rarely triggers flares in AIIRDs; if flares occur, they are typically mild. Despite the heightened infection risk, including COVID-19, among AIIRD patients with rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, and other diseases on immunosuppressants, the vaccination rates remain suboptimal. The future directions of vaccination in the era of immunosuppression will likely involve customized vaccines with enhanced adjuvants and alternative delivery methods. By addressing the unique challenges faced by immunosuppressed individuals, we may improve vaccine efficacy, reduce the risk of infections, and ultimately enhance the health outcomes. Additionally, clinical trials to evaluate the safety and efficacy of temporarily discontinuing immunosuppressants during vaccination in various AIIRDs are crucial.

Published
2023
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199. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Author

Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Kamidani S, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Türeli S, Makhene M, Crandon S, Montefiori DC, Makowski M, Smith DJ, Nayak SU, Roberts PC, and Beigel JH

Subjects
Humans, SARS-CoV-2 genetics, Broadly Neutralizing Antibodies, COVID-19 Vaccines adverse effects, COVID-19 prevention & control
Abstract

Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID 50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID 50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037 ., (© 2023. The Author(s).)

Published
2023
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200. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

Author

Rouphael NG, Branche AR, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Netzl A, Smith DJ, Telu K, Mu J, Makowski M, Makhene MK, Crandon S, Montefiori DC, Roberts PC, and Beigel JH

Abstract

In this brief report, we compare the magnitude and durability of the serologic response of one versus two doses (separated by 56 days) of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults.

Published
2023
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