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1. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.

Author

Park, Han-Sol, Yin, Anna, Barranta, Caelan, Lee, John, Caputo, Christopher, Sachithanandham, Jaiprasath, Li, Maggie, Yoon, Steve, Sitaras, Ioannis, Jedlicka, Anne, Eby, Yolanda, Ram, Malathi, Fernandez, Reinaldo, Baker, Owen, Shenoy, Aarthi, Mosnaim, Giselle, Fukuta, Yuriko, Patel, Bela, Heath, Sonya, Levine, Adam, Meisenberg, Barry, Spivak, Emily, Anjan, Shweta, Huaman, Moises, Blair, Janis, Zand, Martin, Cachay, Edward, Raval, Jay, Kassaye, Seble, Marshall, Christi, Yarava, Anusha, Lane, Karen, McBee, Nichol, Gawad, Amy, Karlen, Nicky, Singh, Atika, Ford, Daniel, Jabs, Douglas, Appel, Lawrence, Shade, David, Lau, Bryan, Ehrhardt, Stephan, Baksh, Sheriza, Shapiro, Janna, Ou, Jiangda, Na, Yu, Knoll, Maria, Ornelas-Gatdula, Elysse, Arroyo-Curras, Netzahualcoyotl, Gniadek, Thomas, Caturegli, Patrizio, Wu, Jinke, Ndahiro, Nelson, Betenbaugh, Michael, Hanley, Daniel, Casadevall, Arturo, Shoham, Shmuel, Bloch, Evan, Gebo, Kelly, Tobian, Aaron, Laeyendecker, Oliver, Pekosz, Andrew, Klein, Sabra, Sullivan, David, Paxton, James, Gerber, Jonathan, Petrini, Joann, Broderick, Patrick, Rausch, William, Cordisco, Marie, Hammel, Jean, Greenblatt, Benjamin, Cluzet, Valerie, Cruser, Daniel, Oei, Kevin, Abinante, Matthew, Hammitt, Laura, Sutcliffe, Catherine, Currier, Judith, Forthal, Donald, and Ziman, Alyssa

Subjects
COVID-19, Immunoglobulins, Immunotherapy, Humans, COVID-19, COVID-19 Serotherapy, Antibodies, Viral, Immunization, Passive, Hospitalization, SARS-CoV-2, Male, Female, Middle Aged, Adult, Immunoglobulin G, Antibodies, Neutralizing, Double-Blind Method, Aged, Blood Donors, Outpatients
Abstract

BACKGROUNDCOVID-19 convalescent plasma (CCP) virus-specific antibody levels that translate into recipient posttransfusion antibody levels sufficient to prevent disease progression are not defined.METHODSThis secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipients within the outpatient, double-blind, randomized clinical trial that compared CCP to control plasma. The majority of COVID-19 CCP arm hospitalizations (15/17, 88%) occurred in this unvaccinated, seronegative subgroup. A functional cutoff to delineate recipient high versus low posttransfusion antibody levels was established by 2 methods: (i) analyzing virus neutralization-equivalent anti-Spike receptor-binding domain immunoglobulin G (anti-S-RBD IgG) responses in donors or (ii) receiver operating characteristic (ROC) curve analysis.RESULTSSARS-CoV-2 anti-S-RBD IgG antibody was volume diluted 21.3-fold into posttransfusion seronegative recipients from matched donor units. Virus-specific antibody delivered was approximately 1.2 mg. The high-antibody recipients transfused early (symptom onset within 5 days) had no hospitalizations. A CCP-recipient analysis for antibody thresholds correlated to reduced hospitalizations found a statistical significant association between early transfusion and high antibodies versus all other CCP recipients (or control plasma), with antibody cutoffs established by both methods-donor-based virus neutralization cutoffs in posttransfusion recipients (0/85 [0%] versus 15/276 [5.6%]; P = 0.03) or ROC-based cutoff (0/94 [0%] versus 15/267 [5.4%]; P = 0.01).CONCLUSIONIn unvaccinated, seronegative CCP recipients, early transfusion of plasma units in the upper 30% of study donors antibody levels reduced outpatient hospitalizations. High antibody level plasma units, given early, should be reserved for therapeutic use.TRIAL REGISTRATIONClinicalTrials.gov NCT04373460.FUNDINGDepartment of Defense (W911QY2090012); Defense Health Agency; Bloomberg Philanthropies; the State of Maryland; NIH (3R01AI152078-01S1, U24TR001609-S3, 1K23HL151826NIH); the Mental Wellness Foundation; the Moriah Fund; Octapharma; the Healthnetwork Foundation; the Shear Family Foundation; the NorthShore Research Institute; and the Rice Foundation.

Published
2024

2. COVID-19 convalescent plasma therapy decreases inflammatory cytokines: a randomized controlled trial.

Author

Habtehyimer, Feben, Zhu, Xianming, Redd, Andrew, Gebo, Kelly, Abraham, Alison, Patel, Eshan, Laeyendecker, Oliver, Gniadek, Thomas, Fernandez, Reinaldo, Baker, Owen, Ram, Malathi, Currier, Judith, Fukuta, Yuriko, Gerber, Jonathan, Heath, Sonya, Meisenberg, Barry, Huaman, Moises, Levine, Adam, Shenoy, Aarthi, Anjan, Shweta, Blair, Janis, Cruser, Daniel, Hammitt, Laura, Kassaye, Seble, Mosnaim, Giselle, Patel, Bela, Paxton, James, Raval, Jay, Sutcliffe, Catherine, Abinante, Matthew, Oei, Kevin, Cluzet, Valerie, Cordisco, Marie, Greenblatt, Benjamin, Rausch, William, Shade, David, Gawad, Amy, Klein, Sabra, Pekosz, Andrew, Shoham, Shmuel, Casadevall, Arturo, Bloch, Evan, Hanley, Daniel, Tobian, Aaron, Sullivan, David, Forthal, Donald, and Cachay, Edward

Subjects
COVID-19, COVID-19 serotherapy, SARS-CoV-2, chemokines, convalescent plasma, cytokines, randomized trial, Humans, COVID-19, COVID-19 Serotherapy, Interleukin-6, SARS-CoV-2, Cytokines, Immunization, Passive
Abstract

This study examined the role that cytokines may have played in the beneficial outcomes found when outpatient individuals infected with SARS-CoV-2 were transfused with COVID-19 convalescent plasma (CCP) early in their infection. We found that the pro-inflammatory cytokine IL-6 decreased significantly faster in patients treated early with CCP. Participants with COVID-19 treated with CCP later in the infection did not have the same effect. This decrease in IL-6 levels after early CCP treatment suggests a possible role of inflammation in COVID-19 progression. The evidence of IL-6 involvement brings insight into the possible mechanisms involved in CCP treatment mitigating SARS-CoV-2 severity.

Published
2024

3. Early antibody treatment, inflammation, and risk of post-COVID conditions.

Author

Gebo, Kelly, Heath, Sonya, Fukuta, Yuriko, Zhu, Xianming, Baksh, Sheriza, Abraham, Allison, Habtehyimer, Feben, Shade, David, Ruff, Jessica, Ram, Malathi, Laeyendecker, Oliver, Fernandez, Reinaldo, Patel, Eshan, Baker, Owen, Shoham, Shmuel, Cachay, Edward, Currier, Judith, Gerber, Jonathan, Meisenberg, Barry, Hammitt, Laura, Huaman, Moises, Levine, Adam, Mosnaim, Giselle, Patel, Bela, Paxton, James, Raval, Jay, Sutcliffe, Catherine, Anjan, Shweta, Gniadek, Thomas, Kassaye, Seble, Blair, Janis, Lane, Karen, McBee, Nichol, Gawad, Amy, Das, Piyali, Klein, Sabra, Pekosz, Andrew, Bloch, Evan, Hanley, Daniel, Casadevall, Arturo, Tobian, Aaron, Sullivan, David, and Forthal, Donald

Subjects
COVID-19, COVID-19 serotherapy, chemokines, cytokines, interleukin-6, post-COVID condition (PCC), post-acute sequelae of COVID (PASC)
Abstract

Post-COVID conditions (PCCs) are common and have significant morbidity. Risk factors for PCC include advancing age, female sex, obesity, and diabetes mellitus. Little is known about treatment, inflammation, and PCC. Among 882 individuals with confirmed SARS-CoV-2 infection participating in a randomized trial of COVID-19 convalescent plasma (CCP) vs control plasma with available biospecimens and symptom data, the association between early CCP treatment, cytokine levels, and PCC was evaluated. Cytokine and chemokine levels were assessed at baseline, day 14, and day 90 using a multiplexed sandwich immunoassay (Meso Scale Discovery). Presence of any self-reported PCC symptoms was assessed at day 90. Associations between CCP treatment, cytokine levels, and PCC were examined using multivariate logistic regression models. One third of the 882 participants had day 90 PCC symptoms, with fatigue (14.5%) and anosmia (14.5%) being most common. Cytokine levels decreased from baseline to day 90. In a multivariable analysis, female sex (adjusted odds ratio [AOR] = 2.69 [1.93-3.81]), older age (AOR = 1.32 [1.17-1.50]), and elevated baseline levels of IL-6 (AOR = 1.59 [1.02-2.47]) were independently associated with development of PCC. Those who received early CCP treatment (≤5 days after symptom onset) compared to late CCP treatment had statistically significant lower odds of PCC. IMPORTANCE Approximately 20% of individuals infected with SARS-CoV-2 experienced long-term health effects, as defined PCC. However, it is unknown if there are any early biomarkers associated with PCC or whether early intervention treatments may decrease the risk of PCC. In a secondary analysis of a randomized clinical trial, this study demonstrates that among outpatients with SARS-CoV-2, increased IL-6 at time of infection is associated with increased odds of PCC. In addition, among individuals treated early, within 5 days of symptom onset, with COVID-19 convalescent plasma, there was a trend for decreased odds of PCC after adjusting for other demographic and clinical characteristics. Future treatment studies should be considered to evaluate the effect of early treatment and anti-IL-6 therapies on PCC development.

Published
2023

4. Transfusion reactions associated with COVID-19 convalescent plasma in outpatient clinical trials.

Author

Huaman, Moises, Raval, Jay, Paxton, James, Mosnaim, Giselle, Patel, Bela, Anjan, Shweta, Meisenberg, Barry, Levine, Adam, Marshall, Christi, Yarava, Anusha, Shenoy, Aarthi, Heath, Sonya, Currier, Judith, Fukuta, Yuriko, Blair, Janis, Spivak, Emily, Petrini, Joann, Broderick, Patrick, Rausch, William, Cordisco, MarieElena, Hammel, Jean, Greenblatt, Benjamin, Cluzet, Valerie, Cruser, Daniel, Oei, Kevin, Abinante, Matthew, Hammitt, Laura, Sutcliffe, Catherine, Forthal, Donald, Zand, Martin, Cachay, Edward, Kassaye, Seble, Ram, Malathi, Wang, Ying, Das, Piyali, Lane, Karen, McBee, Nichol, Gawad, Amy, Karlen, Nicky, Ford, Daniel, Laeyendecker, Oliver, Pekosz, Andrew, Klein, Sabra, Ehrhardt, Stephan, Lau, Bryan, Baksh, Sheriza, Shade, David, Casadevall, Arturo, Hanley, Daniel, Ou, Jiangda, Gniadek, Thomas, Ziman, Alyssa, Shoham, Shmuel, Gebo, Kelly, Bloch, Evan, Tobian, Aaron, Sullivan, David, and Gerber, Jonathan

Subjects
Humans, COVID-19, COVID-19 Serotherapy, Immunization, Passive, Outpatients, SARS-CoV-2, Transfusion Reaction, Urticaria, Randomized Controlled Trials as Topic
Abstract

BACKGROUND: COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials. STUDY DESIGN AND METHODS: We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders. RESULTS: The combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications. DISCUSSION: Outpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19.

Published
2023

5. Dynamics of inflammatory responses after SARS-CoV-2 infection by vaccination status in the USA: a prospective cohort study.

Author

Hammitt, Laura, Kassaye, Seble, Mosnaim, Giselle, Patel, Bela, Paxton, James, Raval, Jay, Sutcliffe, Catherine, Abinante, Matthew, Broderick, Patrick, Cluzet, Valerie, Cordisco, Marie, Greenblatt, Benjamin, Petrini, Joann, Rausch, William, Shade, David, Lane, Karen, Gawad, Amy, Klein, Sabra, Pekosz, Andrew, Shoham, Shmuel, Casadevall, Arturo, Bloch, Evan, Hanley, Daniel, Sullivan, David, Tobian, Aaron, Zhu, Xianming, Gebo, Kelly, Abraham, Alison, Habtehyimer, Feben, Patel, Eshan, Laeyendecker, Oliver, Gniadek, Thomas, Fernandez, Reinaldo, Baker, Owen, Ram, Malathi, Cachay, Edward, Currier, Judith, Fukuta, Yuriko, Gerber, Jonathan, Heath, Sonya, Meisenberg, Barry, Huaman, Moises, Levine, Adam, Shenoy, Aarthi, Anjan, Shweta, Blair, Janis, Cruser, Daniel, and Forthal, Donald

Subjects
United States, Humans, Female, Male, Adolescent, Adult, COVID-19, Vascular Endothelial Growth Factor A, SARS-CoV-2, COVID-19 Vaccines, Interleukin-7, Interleukin-8, Prospective Studies, COVID-19 Serotherapy, Cytokines
Abstract

BACKGROUND: Cytokines and chemokines play a critical role in the response to infection and vaccination. We aimed to assess the longitudinal association of COVID-19 vaccination with cytokine and chemokine concentrations and trajectories among people with SARS-CoV-2 infection. METHODS: In this longitudinal, prospective cohort study, blood samples were used from participants enrolled in a multi-centre randomised trial assessing the efficacy of convalescent plasma therapy for ambulatory COVID-19. The trial was conducted in 23 outpatient sites in the USA. In this study, participants (aged ≥18 years) were restricted to those with COVID-19 before vaccination or with breakthrough infections who had blood samples and symptom data collected at screening (pre-transfusion), day 14, and day 90 visits. Associations between COVID-19 vaccination status and concentrations of 21 cytokines and chemokines (measured using multiplexed sandwich immunoassays) were examined using multivariate linear mixed-effects regression models, adjusted for age, sex, BMI, hypertension, diabetes, trial group, and COVID-19 waves (pre-alpha or alpha and delta). FINDINGS: Between June 29, 2020, and Sept 30, 2021, 882 participants recently infected with SARS-CoV-2 were enrolled, of whom 506 (57%) were female and 376 (43%) were male. 688 (78%) of 882 participants were unvaccinated, 55 (6%) were partly vaccinated, and 139 (16%) were fully vaccinated at baseline. After adjusting for confounders, geometric mean concentrations of interleukin (IL)-2RA, IL-7, IL-8, IL-15, IL-29 (interferon-λ), inducible protein-10, monocyte chemoattractant protein-1, and tumour necrosis factor-α were significantly lower among the fully vaccinated group than in the unvaccinated group at screening. On day 90, fully vaccinated participants had approximately 20% lower geometric mean concentrations of IL-7, IL-8, and vascular endothelial growth factor-A than unvaccinated participants. Cytokine and chemokine concentrations decreased over time in the fully and partly vaccinated groups and unvaccinated group. Log10 cytokine and chemokine concentrations decreased faster among participants in the unvaccinated group than in other groups, but their geometric mean concentrations were generally higher than fully vaccinated participants at 90 days. Days since full vaccination and type of vaccine received were not correlated with cytokine and chemokine concentrations. INTERPRETATION: Initially and during recovery from symptomatic COVID-19, fully vaccinated participants had lower concentrations of inflammatory markers than unvaccinated participants suggesting vaccination is associated with short-term and long-term reduction in inflammation, which could in part explain the reduced disease severity and mortality in vaccinated individuals. FUNDING: US Department of Defense, National Institutes of Health, Bloomberg Philanthropies, State of Maryland, Mental Wellness Foundation, Moriah Fund, Octapharma, HealthNetwork Foundation, and the Shear Family Foundation.

Published
2023

6. Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial

Author

Baksh, Sheriza N, Heath, Sonya L, Fukuta, Yuriko, Shade, David, Meisenberg, Barry, Bloch, Evan M, Tobian, Aaron AR, Spivak, Emily S, Patel, Bela, Gerber, Jonathan, Raval, Jay S, Forthal, Donald, Paxton, James, Mosnaim, Giselle, Anjan, Shweta, Blair, Janis, Cachay, Edward, Currier, Judith, Das, Piyali, Huaman, Moises, Sutcliffe, Catherine, Yarava, Anusha, Casadevall, Arturo, Sullivan, David, Hanley, Daniel, and Gebo, Kelly A

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Humans, COVID-19, SARS-CoV-2, Outpatients, Syndrome, Immunization, Passive, COVID-19 Serotherapy, COVID-19 serotherapy, plasma, symptom duration, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundCoronavirus disease 2019 (COVID-19) convalescent plasma (CCP) reduces hospitalizations among outpatients treated early after symptom onset. It is unknown whether CCP reduces time to symptom resolution among outpatients.MethodsWe evaluated symptom resolution at day 14 by trial arm using an adjusted subdistribution hazard model, with hospitalization as a competing risk. We also assessed the prevalence of symptom clusters at day 14 between treatments. Clusters were defined based on biologic clustering, impact on ability to work, and an algorithm.ResultsAmong 1070 outpatients followed up after transfusion, 381 of 538 (70.8%) receiving CCP and 381 of 532 (71.6%) receiving control plasma were still symptomatic (P = .78) at day 14. Associations between CCP and symptom resolution by day 14 did not differ significantly from those in controls after adjustment for baseline characteristics (adjusted subdistribution hazard ratio, 0.99; P = .62). The most common cluster consisted of cough, fatigue, shortness of breath, and headache and was found in 308 (57.2%) and 325 (61.1%) of CCP and control plasma recipients, respectively (P = .16).ConclusionsIn this trial of outpatients with early COVID-19, CCP was not associated with faster resolution of symptoms compared with control. Overall, there were no differences by treatment in the prevalence of each symptom or symptom clusters at day 14.Clinical trials registrationNCT04373460.

Published
2023

7. Transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection: a double-blinded, phase 2 randomized, controlled trial

Author

Shoham, Shmuel, Bloch, Evan M, Casadevall, Arturo, Hanley, Daniel, Lau, Bryan, Gebo, Kelly, Cachay, Edward, Kassaye, Seble G, Paxton, James H, Gerber, Jonathan, Levine, Adam C, Naeim, Arash, Currier, Judith, Patel, Bela, Allen, Elizabeth S, Anjan, Shweta, Appel, Lawrence, Baksh, Sheriza, Blair, Paul W, Bowen, Anthony, Broderick, Patrick, Caputo, Christopher A, Cluzet, Valerie, Cordisco, Marie Elena, Cruser, Daniel, Ehrhardt, Stephan, Forthal, Donald, Fukuta, Yuriko, Gawad, Amy L, Gniadek, Thomas, Hammel, Jean, Huaman, Moises A, Jabs, Douglas A, Jedlicka, Anne, Karlen, Nicky, Klein, Sabra, Laeyendecker, Oliver, Lane, Karen, McBee, Nichol, Meisenberg, Barry, Merlo, Christian, Mosnaim, Giselle, Park, Han-Sol, Pekosz, Andrew, Petrini, Joann, Rausch, William, Shade, David M, Shapiro, Janna R, Singleton, J Robinson, Sutcliffe, Catherine, Thomas, David L, Yarava, Anusha, Zand, Martin, Zenilman, Jonathan M, Tobian, Aaron AR, and Sullivan, David J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Biodefense, Lung, Pneumonia, Clinical Trials and Supportive Activities, Vaccine Related, Prevention, Infectious Diseases, Emerging Infectious Diseases, Clinical Research, Infection, Good Health and Well Being, Humans, Adolescent, Adult, SARS-CoV-2, COVID-19, Post-Exposure Prophylaxis, COVID-19 Serotherapy, Double-Blind Method, Immunization, Passive, post-exposure-prophylaxis, convalescent plasma, transfusion, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundThe efficacy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection.MethodsThis double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed coronavirus disease 2019 (COVID-19) in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was new SARS-CoV-2 infection.ResultsIn total, 180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for screening SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) positivity. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs 25.2 days; P = .49) and COVID-19 (26.3 vs 25.9 days; P = .35) was similar for both groups.ConclusionsAdministration of high-titer CCP as post-exposure prophylaxis, although appearing safe, did not prevent SARS-CoV-2 infection.Clinical trials registrationNCT04323800.

Published
2023

8. Phosphoproteomics predict response to midostaurin plus chemotherapy in independent cohorts of FLT3-mutated acute myeloid leukaemia

Author

Borek, Weronika E., Nobre, Luis, Pedicona, S. Federico, Campbell, Amy E., Christopher, Josie A., Nawaz, Nazrath, Perkins, David N., Moreno-Cardoso, Pedro, Kelsall, Janet, Ferguson, Harriet R., Patel, Bela, Gallipoli, Paolo, Arruda, Andrea, Ambinder, Alex J., Thompson, Andrew, Williamson, Andrew, Ghiaur, Gabriel, Minden, Mark D., Gribben, John G., Britton, David J., Cutillas, Pedro R., and Dokal, Arran D.

Published
2024
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9. Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study

Author

Sahner, David, Tierney, John, Vogel, Susan E., Herpin, Betsey R., Smolskis, Mary C., McKay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Raim, Sharon Segal, Hensely, Lisa, Lorenzo, Johsua, Mock, Rebecca, Zuckerman, Judith, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Kang, Nayon, Barrett, Kevin, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Currier, Judy, Hughes, Eric, Harrigan, Rachel H., Amos, Laura, Carlsen, Amy, Carter, Anita, Collins, Gary, Davis, Bionca, Denning, Eileen, DuChene, Alain, Eckroth, Kate, Engen, Nicole, Frase, Alex, Gandits, Greg, Grund, Birgit, Harrison, Merrie, Hurlbut, Nancy, Kaiser, Payton, Koopmeiners, Joseph, Larson, Gregg, Meger, Sue, Mistry, Shweta Sharma, Murray, Thomas, Nelson, Ray, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Siegel, Lianne, Thompson, Greg, Vock, David, Walski, Jamie, Gelijns, Annetine C., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Burris, Sarah, Bedoya, Gabriela, Gupta, Lola, Overbey, Jessica R., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Sandkovsky, Uriel, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samatha, Wang, Samatha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Vekstein, Andrew M., Ko, Emily R., Dreyer, Grace R., Stafford, Neil, Brooks, Megan, Der, Tatyana, Witte, Marie, Gamarallage, Ruwan, Franzone, John, Ivey, Noel, Lumsden, Rebecca H., Mosaly, Nilima, Mourad, Ahmaad, Holland, Thomas L., Motta, Mary, Lane, Kathleen, McGowan, Lauren M., Stout, Jennifer, Aloor, Heather, Bragg, Kennesha M., Toledo, Barvina, McLendon-Arvik, Beth, Bussadori, Barbara, Hollister, Beth A., Griffin, Michelle, Giangiacomo, Dana M., Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Johnathan, Vonderhaar, Derek, Nossaman, Bobby, Sylvia Laudun, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Perin, Emerson, Costello, Briana, Manian, Prasad, Sohail, M. Rizwan, Postalian, Alexander, Hinsu, Punit, Watson, Carolyn, Chen, James, Fink, Melyssa, Sturgis, Lydia, Walker, Kim, Mahon, Kim, Parenti, Jennifer, Kappenman, Casey, Knight, Aryn, Sturek, Jeffrey M., Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Adams, Amy, Badhwar, Vinay, Sharma, Sunil, Peppers, Briana, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresico, Lisa, Glaze, Chad, Evans, Raquel, Di, Fang, Carlson, Shawn, Aucremanne, Tanja, Tennant, Connie, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Williams, Roger, Bunner, Robin, Traverse, Jay H., Rhame, Frank, Huelster, Joshua, Kethireddy, Rajesh, Davies, Irena, Salamanca, Julianne, Majeski, Christine, Skelton, Paige, Zarambo, Maria, Sarafolean, Andrea, Bowdish, Michael E., Borok, Zea, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, Mary, Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Loxano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Quesada, Christine, Hamilton, Luke, Escobar, Jose, Leshnower, Brad, Bender, William, Sharifpour, Milad, Miller, Jeffrey, Farrington, Woodrow, Baio, Kim T., McBride, Mary, Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elisabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberly, Audette, Mathew, Fleischmann, Emily, Akbari, Kreshta, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nyguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Johnson, Haley, Newton, Crystallee, Parr, Doug, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Moroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Walker-Ignasiak, Rebecca, North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Muzikansky, Ariela, Morse, Richard, Fitzgerald, Laura, Morin, Haley D., Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Steingrub, Jay H., Hou, Peter K., Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Romain, Sarah, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Andromidas, Konstantinos, Banner-Goodspeed, Valerie, Bolstad, Michael, Boyle, Katherine L., Cabrera, Payton, deVilla, Arnaldo, Ellis, Joshua C., Grafals, Ana, Hayes, Sharon, Higgins, Conor, Kurt, Lisa, Kurtzman, Nicholas, Redman, Kimberly, Rosseto, Elinita, Scaffidi, Douglas, Filbin, Michael R., Hibbert, Kathryn A., Parry, Blair, Margolin, Justin, Hillis, Brooklynn, Hamer, Rhonda, Brait, Kelsey, Beakes, Caroline, McKaig, Brenna, Kugener, Eleonore, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah, Hendey, Gregory, Kangelaris, Kirsten, Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Yee, Kimberley J., Jauregui, Alejandra E., Zhuo, Hanjing, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Lim, George W., Chang, Steven Y., Lin, Michael Y., Vargas, Julia, Sihota, Hena, Beutler, Rebecca, Agarwal, Trisha, Wilson, Jennifer G., Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan H., Roque, Jonasel, Wang, Henry, Huebinger, Ryan M., Patel, Bela, Vidales, Elizabeth, Albertson, Timothy, Hardy, Erin, Harper, Richart, Moss, Marc A., Baduashvili, Amiran, Chauhan, Lakshmi, Douin, David J., Martinez, Flora, Finck, Lani L., Bastman, Jill, Howell, Michelle, Higgins, Carrie, McKeehan, Jeffrey, Finigan, Jay, Stubenrauch, Peter, Janssen, William J., Griesmer, Christine, VerBurg, Olivia, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jimenez, Jose, Olbrich, Norman, McDonough, Kelli, Jia, Shijing, Hanna, Sinan, Gong, Michelle N., Richardson, Lynne D., Nair, Rahul, Lopez, Brenda, Amosu, Omowunmi, Offor, Obiageli, Tzehaie, Hiwet, Nkemdirim, William, Boujid, Sabah, Mosier, Jarrod M., Hypes, Cameron, Campbell, Elizabeth Salvagio, Bixby, Billie, Gilson, Boris, Lopez, Anitza, Bime, Christian, Parthasarathy, Sairam, Cano, Ariana M., Hite, R. Duncan, Terndrup, Thomas E., Wiedemann, Herbert P., Hudock, Kristin, Tanzeem, Hammad, More, Harshada, Martinkovic, Jamie, Sellers, Susan, Houston, Judy, Burns, Mary, Kiran, Simra, Roads, Tammy, Kennedy, Sarah, Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Dugar, Siddharth, Sahoo, Debasis, Yealy, Donald M., Angus, Derek C., Weissman, Alexandra J., Vita, Tina M., Berryman, Emily, Hough, Catherine L., Khan, Akram, Krol, Olivia F., Mills, Emmanuel, Kinjal, Mistry, Briceno, Genesis, Reddy, Raju, Hubel, Kinsley, Jouzestani, Milad K., McDougal, Madeline, Deshmukh, Rupali, Johnston, Nicholas J., Robinson, Bryce H., Gundel, Staphanie J., Katsandres, Sarah C., Chen, Peter, Torbati, Sam S., Parimon, Tanyalak, Caudill, Antonina, Mattison, Brittany, Jackman, Susan E., Chen, Po-En, Bayoumi, Emad, Ojukwu, Cristabelle, Fine, Devin, Weissberg, Gwendolyn, Isip, Katherine, Choi-Kuaea, Yunhee, Mehdikhani, Shaunt, Dar, Tahir B., Fleury Augustin, Nsole Biteghe, Tran, Dana, Dukov, Jennifer Emilow, Matusov, Yuri, Choe, June, Hindoyan, Niree A., Wynter, Timothy, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Caudill, Antonia, O’Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Miller, Chadwick, Files, D. Clark, Gibbs, Kevin W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Palacios, D. Rafael, Parks, Lisa, Hicks, Madeline, Goodwin, Andrew J., Kilb, Edward F., Lematty, Caitlan T., Patti, Kerilyn, Grady, Abigail, Rasberry, April, Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sarah N., Mayer, Kirby P., Pharm.D., Brittany Bissel, Trott, Terren, Rehman, Shahnaz, de Wit, Marjolein, Mason, Jessica, Bledsoe, Joseph, Knowlton, Kirk U., Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Pelton, Ithan, Armbruster, Brent P., Montgomery, Quinn, Kumar, Naresh, Fergus, Melissa, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Klippel, Carolyn, Jensen, Hannah, Duckworth, Sarah, Gray, Andrew, Burke, Tyler, Knox, Dan, Lumpkin, Jenna, Aston, Valerie T., Applegate, Darrin, Serezlic, Erna, Brown, Katie, Merril, Mardee, Harris, Estelle S., Middleton, Elizabeth A., Barrios, Macy A.G., Greer, Jorden, Schmidt, Amber D., Webb, Melissa K., Paine, Roert, Callahan, Sean J., Waddoups, Lindsey J., Yamane, Misty B., Self, Wesley H., Rice, Todd W., Casey, Jonathan D., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Menon, Vidya, Kasubhai, Moiz, Pillai, Anjana, Daniel, Jean, Sittler, Daniel, Kanna, Balavenkatesh, Jilani, Nargis, Amaro, Francisco, Santana, Jessica, Lyakovestsky, Aleksandr, Madhoun, Issa, Desroches, Louis Marie, Amadon, Nicole, Bahr, Alaa, Ezzat, Imaan, Guerrero, Maryanne, Padilla, Joane, Fullmer, Jessie, Singh, Inderpreet, Ali Shah, Syed Hamad, Narang, Rajeev, Mock, Polly, Shadle, Melissa, Hernandez, Brenda, Welch, Kevin, Payne, Andrea, Ertl, Gabriela, Canario, Daniel, Barrientos, Isabel, Goss, Danielle, DeVries, Mattie, Folowosele, Ibidolapo, Garner, Dorothy, Gomez, Mariana, Price, Justin, Bansal, Ekta, Wong, Jim, Faulhaber, Jason, Fazili, Tasaduq, Yeary, Brian, Ndolo, Ruth, Bryant, Christina, Smigeil, Bridgette, Robinson, Philip, Najjar, Rana, Jones, Patrice, Nguyen, Julie, Chin, Christina, Taha, Hassan, Najm, Salah, Smith, Christopher, Moore, Jason, Nassar, Talal, Gallinger, Nick, Christian, Amy, Mauer, D’Amber, Phipps, Ashley, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Landazuri, Rosalynn, Pineda, Jacob, Uribe, Nicole, Garcia, Jose Ruiz, Barbabosa, Cecilia, Sandler, Kaitlyn, Overcash, J. Scott, Marquez, Adrienna, Chu, Hanh, Lee, Kia, Quillin, Kimberly, Garcia, Andrea, Lew, Pauline, Rogers, Ralph, Shehadeh, Fadi, Mylona, Evangelia K., Kaczynski, Matthew, Tran, Quynh-Lam, Benitez, Gregorio, Mishra, Biswajit, Felix, Lewis Oscar, Vafea, Maria Tsikala, Atalla, Eleftheria, Davies, Robin, Hedili, Salma, Monkeberg, Maria Andrea, Tabler, Sandra, Harrington, Britt, Meegada, Sreenath, Koripalli, Venkata Sandeep, Muddana, Prithvi, Jain, Lakshay, Undavalli, Chaitanya, Kavya, Parasa, Ibiwoye, Mofoluwaso, Akilo, Hameed, Lovette, Bryce D., Wylie, Jamie-Crystal, Smith, Diana M., Poon, Kenneth, Eckardt, Paula, Heysu, Rubio-Gomez, Sundararaman, Nithya, Alaby, Doris, Sareli, Candice, Sánchez, Adriana, Popielski, Laura, Kambo, Amy, Viens, Kimberley, Turner, Melissa, Vjecha, Michael J., Weintrob, Amy, Brar, Indira, Markowitz, Norman, Pastor, Erika, Corpuz, Roweena, Alangaden, George, McKinnon, John, Ramesh, Mayur, Herc, Erica, Yared, Nicholas, Lanfranco, Odaliz Abreu, Rivers, Emanuel, Swiderek, Jennifer, Gupta, Ariella Hodari, Pabla, Pardeep, Eliya, Sonia, Jazrawi, Jehan, Delor, Jeremy, Desai, Mona, Cook, Aaron, Jaehne, Anja Kathrina, Gill, Jasreen Kaur, Renaud, Sheri, Sarveswaran, Siva, Gardner, Edward, Scott, James, Bianchini, Monica, Melvin, Casey, Kim, Gina, Wyles, David, Kamis, Kevin, Miller, Rachel, Douglas, Ivor, Haukoos, Jason, Hicks, Carrie, Lazarte, Susana, Marines-Price, Rubria, Osuji, Alice, Agbor Agbor, Barbine Tchamba, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Garcia, Angie, Cha, Christine, Mozaffari, Azadeh, Hernandez, Rosa, Cutrell, James, Kim, Mina, DellaValle, Natalie, Gonzales, Sonia, Somboonwit, Charurut, Oxner, Asa, Guerra, Lucy, Hayes, Michael, Nguyen, Thi, Tran, Thanh, Pinto, Avenette, Hatlen, Timothy, Anderson, Betty, Zepeda-Gutierrez, Ana, Martin, Dannae, Temblador, Cindi, Cuenca, Avon, Tanoviceanu, Roxanne, Prieto, Martha, Guerrero, Mario, Daar, Eric, Correa, Ramiro, Hartnell, Gabe, Wortmann, Glenn, Doshi, Saumil, Moriarty, Theresa, Gonzales, Melissa, Garman, Kristin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Driver, Brian, Frank, Christine, Leviton, Tzivia, Prekker, Matthew, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Kunisaki, Ken M., Wendt, Chris, Melzer, Anne, Wetherbee, Erin, Drekonja, Dimitri, Pragman, Alexa, Hamel, Aimee, Thielen, Abbie, Hassler, Miranda, Walquist, Mary, Augenbraun, Michael, George, Jensen, Demeo, Lynette, Mishko, Motria, Thomas, Lorraine, Tatem, Luis, Dehovitz, Jack, Abassi, Mahsa, Leuck, Anne-Marie, Rao, Via, Pullen, Matthew, Luke, Darlette, LaBar, Derek, Christiansen, Theresa, Howard, Diondra, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Davis-Karim, Anne, Pittman, David, Vasudeva, Shikha S., Johnstone, Jaylynn R., Agnetti, Kate, Davis, Ruby, Trautner, Barbara, Hines-Munson, Casey, Van, John, Dillon, Laura, Wang, Yiqun, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Caldwell, Erin, Humerickhouse, Edward, Boone, David, McGraw, William, Looney, David J., Mehta, Sanjay R., Johns, Scott Thompson, St. John, Melissa, Raceles, Jacqueline, Sear, Emily, Funk, Stephen, Cesarini, Rosa, Fang, Michelle, Nicalo, Keith, Drake, Wonder, Jones, Beatrice, Holtman, Teresa, Nguyen, Hien H., Maniar, Archana, Johnson, Eric A., Nguyen, Lam, Tran, Michelle T., Barrett, Thomas W., Johnston, Tera, Huggins, John T., Beiko, Tatsiana Y., Hughes, Heather Y., McManigle, William C., Tanner, Nichole T., Washburn, Ronald G., Ardelt, Magdalena, Tuohy, Patricia A., Mixson, Jennifer L., Hinton, Charles G., Thornley, Nicola, Allen, Heather, Elam, Shannon, Boatman, Barry, Baber, Brittany J., Ryant, Rudell, Roller, Brentin, Nguyen, Chinh, Mikail, Amani Morgan, Research, Marivic Hansen, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Holodniy, Mark, Chary, Aarthi, Lu, Kan, Peters, Theresa, Lopez, Jessica, Tan, Susanna Yu, Lee, Robert H., Asghar, Aliya, Karyn Isip, Tasadduq Karim, Le, Katherine, Nguyen, Thao, Wong, Shinn, Raben, Dorthe, Murray, Daniel D., Jensen, Tomas O., Peters, Lars, Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Olsson, Christina, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esman, Frederik V.L., Benfield, Thomas, Clausen, Clara Lundetoft, Hovmand, Nichlas, Israelsen, Simone Bastrup, Iversen, Katrine, Leding, Caecilie, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Tingsgard, Sandra, Krohn-Dehli, Louise, Pedersen, Dorthe, Villadsen, Signe, Staehr Jensen, Jens-Ulrik, Overgaard, Rikke, Rastoder, Ema, Heerfordt, Christian, Hedsund, Caroline, Ronn, Christian Phillip, Kamstrup, Peter Thobias, Hogsberg, Dorthe Sandbaek, Bergsoe, Christina, Søborg, Christian, Hissabu, Nuria M.S., Arp, Bodil C., Ostergaard, Lars, Staerke, Nina Breinholt, Yehdego, Yordanos, Sondergaard, Ane, Johansen, Isik S., Pedersen, Andreas Arnholdt, Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Holden, Inge K., Lindvig, Susan O., Helleberg, Marie, Gerstoft, Jan, Kirk, Ole, Jensen, Tomas Ostergaard, Madsen, Birgitte Lindegaard, Pedersen, Thomas Ingemann, Harboe, Zitta Barrella, Roge, Birgit Thorup, Hansen, Thomas Michael, Glesner, Matilde Kanstrup, Lofberg, Sandra Valborg, Nielsen, Ariella Denize, Leicht von Huth, Sebastian, Nielsen, Henrik, Thisted, Rikke Krog, Petersen, Kristine Toft, Juhl, Maria Ruwald, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Clara Ellinor Lindnér, Cecilia Ebba, Wiese, Lothar, Knudsen, Lene Surland, Skrøder Nytofte, Nikolaj Julian, Havmøller, Signe Ravn, Expósito, Maria, Badillo, José, Martínez, Ana, Abad, Elena, Chamorro, Ana, Figuerola, Ariadna, Mateu, Lourdes, España, Sergio, Lucero, Maria Constanza, Santos, José Ramón, Lladós, Gemma, Lopez, Cristina, Carabias, Lydia, Molina-Morant, Daniel, Loste, Cora, Bracke, Carmen, Siles, Adrian, Fernández-Cruz, Eduardo, Di Natale, Marisa, Padure, Sergiu, Gomez, Jimena, Ausin, Cristina, Cervilla, Eva, Balastegui, Héctor, Sainz, Carmen Rodríguez, Lopez, Paco, Carbone, Javier, Escobar, Mariam, Balerdi, Leire, Legarda, Almudena, Roldan, Montserrat, Letona, Laura, Muñoz, José, Camprubí, Daniel, Arribas, Jose R., Sánchez, Rocio Montejano, Díaz-Pollán, Beatriz, Stewart, Stefan Mark, Garcia, Irene, Borobia, Alberto, Mora-Rillo, Marta, Estrada, Vicente, Cabello, Noemi, Nuñez-Orantos, M.J., Sagastagoitia, I., Homen, J.R., Orviz, E., Montalvá, Adrián Sánchez, Espinosa-Pereiro, Juan, Bosch-Nicolau, Pau, Salvador, Fernando, Burgos, Joaquin, Morales-Rull, Jose Luis, Moreno Pena, Anna Maria, Acosta, Cristina, Solé-Felip, Cristina, Horcajada, Juan P., Sendra, Elena, Castañeda, Silvia, López-Montesinos, Inmaculada, Gómez-Junyent, Joan, Gonzáles, Carlota Gudiol, Cuervo, Guilermo, Pujol, Miquel, Carratalà, Jordi, Videla, Sebastià, Günthard, Huldrych, Braun, Dominique L., West, Emily, M’Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, pharmacist, Goes pharmacist, Josefine, Fätkenheuer, Gerd, Malin, Jakob J., Tsertsvadze, Tengiz, Abutidze, Akaki, Chkhartishvili, Nikoloz, Metchurtchlishvili, Revaz, Endeladze, Marina, Paciorek, Marcin, Bursa, Dominik, Krogulec, Dominika, Pulik, Piotr, Ignatowska, Anna, Horban, Andrzej, Bakowska, Elzbieta, Kowaska, Justyna, Bednarska, Agnieszka, Jurek, Natalia, Skrzat-Klapaczynska, Agata, Bienkowski, Carlo, Hackiewicz, Malgorzata, Makowiecki, Michal, Platowski, Antoni, Fishchuk, Roman, Kobrynska, Olena, Levandovska, Khrystyna, Kirieieva, Ivanna, Kuziuk, Mykhailo, Naucler, Pontus, Perlhamre, Emma, Mazouch, Lotta, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina C., Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David C., Ong, Sean W.X., Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Yeo, He Ping, Eriobu, Nnakelu, Kwaghe, Vivian, Zaiyad, Habib, Idoko, Godwin, Uche, Blessing, Selvamuthu, Poongulali, Kumarasamy, Nagalingeswaran, Beulah, Faith Ester, Govindarajan, Narayan, Mariyappan, Kowsalya, Losso, Marcelo H., Abela, Cecilia, Moretto, Renzo, Belloc, Carlos G., Ludueña, Jael, Amar, Josefina, Toibaro, Javier, Macias, Laura Moreno, Fernandez, Lucia, Frare, Pablo S., Chaio, Sebastian R., Pachioli, Valeria, Timpano, Stella M., Sanchez, Marisa del Lujan, de Paz Sierra, Mariana, Stanek, Vanina, Belloso, Waldo, Cilenti, Flavia L., Valentini, Ricardo N., Stryjewski, Martin E., Locatelli, Nicolas, Soler Riera, Maria C., Salgado, Clara, Baeck, Ines M., Di Castelnuovo, Valentina, Zarza, Stella M., Hudson, Fleur, Parmar, Mahesh K.B., Goodman, Anna L., Dphil, Badrock, Jonathan, Gregory, Adam, Goodall, Katharine, Harris, Nicola, Wyncoll, James, Bhagani, S., Rodger, A., Luntiel, A., Patterson, C., Morales, J., Witele, E., Preston, A.-M., Nandani, A., Price, D.A., Hanrath, Aiden, Nell, Jeremy, Patel, Bijal, Hays, Carole, Jones, Geraldine, Davidson, Jade, Bawa, T., Mathews, M., Mazzella, A., Bisnauthsing, K., Aguilar-Jimenez, L., Borchini, F., Hammett, S., Touloumi, Giota, Pantazis, Nikos, Gioukari, Vicky, Souliou, Tania, Antoniadou, A., Protopapas, K., Kavatha, D., Grigoropoulou, S., Oikonomopoulo, C., Moschopoulos, C., Koulouris, N.G., Tzimopoulos, K., Koromilias, A., Argyraki, K., Lourida, P., Bakakos, P., Kalomenidis, I., Vlachakos, V., Barmparessou, Z., Balis, E., Zakynthinos, S., Sigala, I., Gianniou, N., Dima, E., Magkouta, S., Synolaki, E., Konstanta, S., Vlachou, M., Stathopoulou, P., Panagopoulos, P., Petrakis, V., Papazoglou, D., Tompaidou, E., Isaakidou, E., Poulakou, G., Rapti, V., Leontis, K., Nitsotolis, T., Athanasiou, K., Syrigos, K., Kyriakoulis, K., Trontzas, I., Arfara-Melanini, M., Kolonis, V., Kityo, Cissy, Mugerwa, Henry, Kiweewa, Francis, Kimuli, Ivan, Lukaakome, Joseph, Nsereko, Christoher, Lubega, Gloria, Kibirige, Moses, Nakahima, William, Wangi, Deus, Aguti, Evelyne, Generous, Lilian, Massa, Rosemary, Nalaki, Margaret, Magala, Felix, Nabaggala, Phiona Kaweesi, Kidega, Robert, Faith, Oryem Daizy, Florence, Apio, Emmanuel, Ocung, Beacham, Mugoonyi Paul, Geoffrey, Amone, Nakiboneka, Dridah, Apiyo, Paska, Kirenga, Bruce, Atukunda, Angella, Muttamba, Winters, Remmy, Kyeyume, Segawa, Ivan, Pheona, Nsubuga, Kigere, David, Mbabazi, Queen Lailah, Boersalino, Ledra, Nyakoolo, Grace, Fred, Aniongo, Alupo, Alice, Ebong, Doryn, Monday, Edson, Nalubwama, Ritah Norah, Kainja, Milton, Ambrose, Munu, Kwehayo, Vanon, Nalubega, Mary Grace, Ongoli, Augustine, Obbo, Stephen, Sebudde, Nicholus, Alaba, Jeniffer, Magombe, Geoffrey, Tino, Harriet, Obonya, Emmanuel, Lutaakome, Joseph, Kitonsa, Jonathan, Onyango, Martin, Naboth, Tukamwesiga, Naluyinda, Hadijah, Nanyunja, Regina, Irene, Muttiibwa, Jane, Biira, Wimfred, Kyobejja, Leonard, Ssemazzi, Deus, Tkiinomuhisha, Babra, Namasaba, Taire, Paul, Nabankema, Evelyn, Ogavu, Joseph, Mugerwa, Oscar, Okoth, Ivan, Mwebaze, Raymond, Mugabi, Timothy, Makhoba, Anthony, Arikiriza, Phiona, Theresa, Nabuuma, Nakayima, Hope, Frank, Kisuule, Ramgi, Patrícia, Pereira, Kássia, Osinusi, Anu, Cao, Huyen, Klekotka, Paul, Price, Karen, Nirula, Ajay, Osei, Suzette, Tipple, Craig, Wills, Angela, Peppercorn, Amanda, Watson, Helen, Gupta, Rajesh, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Margolis, David, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Zhu, Quing, Seegobin, Seth, Gibbs, Michael, Latchman, Mickel, Hasior, Katarzyna, Bouquet, Jerome, Wei, Jianxin, Streicher, Katie, Schmelzer, Albert, Brooks, Dennis, Butcher, Jonny, Tonev, Dimitar, Arbetter, Douglas, Damstetter, Philippe, Legenne, Philippe, Stumpp, Michael, Goncalves, Susana, Ramanathan, Krishnan, Chandra, Richa, Baseler, Beth, Teitelbaum, Marc, Schechner, Adam, Holley, H. Preston, Jankelevich, Shirley, Becker, Nancy, Dolney, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Asomah, Mabel, Jato, Yvonne, Stottlemyer, April, Tang, Olivia, Vanderpuye, Sharon, Yeon, Lindsey, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonald, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Schaffhauser, Marylu, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, C.K., Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Kopka, Stacey, Shelley, Denise M., Mendez, Gregg, Brown, Shawn, Albert, Sara, Balde, Abby, Baracz, Michelle, Bielica, Mona, Billouin-Frazier, Shere, Choudary, Jay, Dixon, Mary, Eyler, Carolyn, Frye, Leanne, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hogarty, Debi, Huber, Lynda, Krauss, Gary, Lake, Eileen, Manandhar, Meryan, Rudzinski, Erin, Sandrus, Jen, Suders, Connie, Natarajan, Ven, Rupert, Adam W., Baseler, Michael, Lynam, Danielle, Imamichi, Tom, Laverdure, Sylvain, McCormack, Ashley, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Khan, Ayub, Hazen, Allison, Badralmaa, Yunden, Smith, Kenneth, Patel, Bhakti, Kubernac, Amanda, Kubernac, Robert, Hoover, Marie L., Solomon, Courtney, Rashid, Marium, Murphy, Joseph, Brown, Craig, DuChateau, Nadine, Ellis, Sadie, Flosi, Adam, Fox, Lisa, Johnson, Les, Nelson, Rich, Stojanovic, Jelena, Treagus, Amy, Wenner, Christine, Williams, Richard, Jensen, Tomas O, Murray, Thomas A, Grandits, Greg A, Jain, Mamta K, Shaw-Saliba, Kathryn, Matthay, Michael A, Baker, Jason V, Dewar, Robin L, Goodman, Anna L, Hatlen, Timothy J, Highbarger, Helene C, Lallemand, Perrine, Leshnower, Bradley G, Looney, David, Moschopoulos, Charalampos D, Murray, Daniel D, Mylonakis, Eleftherios, Rehman, M Tauseef, Rupert, Adam, Stevens, Randy, Turville, Stuart, Wick, Katherine, Lundgren, Jens, and Ko, Emily R

Published
2024
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10. Early Outpatient Treatment for Covid-19 with Convalescent Plasma

Author

Sullivan, David J, Gebo, Kelly A, Shoham, Shmuel, Bloch, Evan M, Lau, Bryan, Shenoy, Aarthi G, Mosnaim, Giselle S, Gniadek, Thomas J, Fukuta, Yuriko, Patel, Bela, Heath, Sonya L, Levine, Adam C, Meisenberg, Barry R, Spivak, Emily S, Anjan, Shweta, Huaman, Moises A, Blair, Janis E, Currier, Judith S, Paxton, James H, Gerber, Jonathan M, Petrini, Joann R, Broderick, Patrick B, Rausch, William, Cordisco, Marie-Elena, Hammel, Jean, Greenblatt, Benjamin, Cluzet, Valerie C, Cruser, Daniel, Oei, Kevin, Abinante, Matthew, Hammitt, Laura L, Sutcliffe, Catherine G, Forthal, Donald N, Zand, Martin S, Cachay, Edward R, Raval, Jay S, Kassaye, Seble G, Foster, E Colin, Roth, Michael, Marshall, Christi E, Yarava, Anusha, Lane, Karen, McBee, Nichol A, Gawad, Amy L, Karlen, Nicky, Singh, Atika, Ford, Daniel E, Jabs, Douglas A, Appel, Lawrence J, Shade, David M, Ehrhardt, Stephan, Baksh, Sheriza N, Laeyendecker, Oliver, Pekosz, Andrew, Klein, Sabra L, Casadevall, Arturo, Tobian, Aaron AR, and Hanley, Daniel F

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Neurodegenerative, Patient Safety, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Ambulatory Care, COVID-19, Disease Progression, Double-Blind Method, Hospitalization, Humans, Immunization, Passive, Treatment Outcome, United States, COVID-19 Serotherapy, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundPolyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.MethodsIn this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.ResultsParticipants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.ConclusionsIn participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).

Published
2022

11. How do I implement an outpatient program for the administration of convalescent plasma for COVID‐19?

Author

Bloch, Evan M, Tobian, Aaron AR, Shoham, Shmuel, Hanley, Daniel F, Gniadek, Thomas J, Cachay, Edward R, Meisenberg, Barry R, Kafka, Kimberly, Marshall, Christi, Heath, Sonya L, Shenoy, Aarthi, Paxton, James H, Levine, Adam, Forthal, Donald, Fukuta, Yuriko, Huaman, Moises A, Ziman, Alyssa, Adamski, Jill, Gerber, Jonathan, Cruser, Daniel, Kassaye, Seble G, Mosnaim, Giselle S, Patel, Bela, Metcalf, Ryan A, Anjan, Shweta, Reisler, Ronald B, Yarava, Anusha, Lane, Karen, McBee, Nichol, Gawad, Amy, Raval, Jay S, Zand, Martin, Abinante, Matthew, Broderick, Patrick B, Casadevall, Arturo, Sullivan, David, and Gebo, Kelly A

Subjects
Emerging Infectious Diseases, Prevention, Infectious Diseases, Good Health and Well Being, COVID-19, Humans, Immunization, Passive, Outpatients, Pandemics, SARS-CoV-2, United States, COVID-19 Serotherapy, ambulatory care, antibodies, blood transfusion, COVID-19 serotherapy, monoclonal, plasma, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Immunology, Cardiovascular System & Hematology
Abstract

Convalescent plasma, collected from donors who have recovered from a pathogen of interest, has been used to treat infectious diseases, particularly in times of outbreak, when alternative therapies were unavailable. The COVID-19 pandemic revived interest in the use of convalescent plasma. Large observational studies and clinical trials that were executed during the pandemic provided insight into how to use convalescent plasma, whereby high levels of antibodies against the pathogen of interest and administration early within the time course of the disease are critical for optimal therapeutic effect. Several studies have shown outpatient administration of COVID-19 convalescent plasma (CCP) to be both safe and effective, preventing clinical progression in patients when administered within the first week of COVID-19. The United States Food and Drug Administration expanded its emergency use authorization (EUA) to allow for the administration of CCP in an outpatient setting in December 2021, at least for immunocompromised patients or those on immunosuppressive therapy. Outpatient transfusion of CCP and infusion of monoclonal antibody therapies for a highly transmissible infectious disease introduces nuanced challenges related to infection prevention. Drawing on our experiences with the clinical and research use of CCP, we describe the logistical considerations and workflow spanning procurement of qualified products, infrastructure, staffing, transfusion, and associated management of adverse events. The purpose of this description is to facilitate the efforts of others intent on establishing outpatient transfusion programs for CCP and other antibody-based therapies.

Published
2022

12. Real-time Prediction for Mechanical Ventilation in COVID-19 Patients using A Multi-task Gaussian Process Multi-objective Self-attention Network

Author

Zhang, Kai, Karanth, Siddharth, Patel, Bela, Murphy, Robert, and Jiang, Xiaoqian

Subjects
Computer Science - Machine Learning, Statistics - Applications
Abstract

We propose a robust in-time predictor for in-hospital COVID-19 patient's probability of requiring mechanical ventilation. A challenge in the risk prediction for COVID-19 patients lies in the great variability and irregular sampling of patient's vitals and labs observed in the clinical setting. Existing methods have strong limitations in handling time-dependent features' complex dynamics, either oversimplifying temporal data with summary statistics that lose information or over-engineering features that lead to less robust outcomes. We propose a novel in-time risk trajectory predictive model to handle the irregular sampling rate in the data, which follows the dynamics of risk of performing mechanical ventilation for individual patients. The model incorporates the Multi-task Gaussian Process using observed values to learn the posterior joint multi-variant conditional probability and infer the missing values on a unified time grid. The temporal imputed data is fed into a multi-objective self-attention network for the prediction task. A novel positional encoding layer is proposed and added to the network for producing in-time predictions. The positional layer outputs a risk score at each user-defined time point during the entire hospital stay of an inpatient. We frame the prediction task into a multi-objective learning framework, and the risk scores at all time points are optimized altogether, which adds robustness and consistency to the risk score trajectory prediction. Our experimental evaluation on a large database with nationwide in-hospital patients with COVID-19 also demonstrates that it improved the state-of-the-art performance in terms of AUC (Area Under the receiver operating characteristic Curve) and AUPRC (Area Under the Precision-Recall Curve) performance metrics, especially at early times after hospital admission., Comment: In review

Published
2021

13. Dynamics of inflammatory responses after SARS-CoV-2 infection by vaccination status in the USA: a prospective cohort study

Author

Zhu, Xianming, Gebo, Kelly A, Abraham, Alison G, Habtehyimer, Feben, Patel, Eshan U, Laeyendecker, Oliver, Gniadek, Thomas J, Fernandez, Reinaldo E, Baker, Owen R, Ram, Malathi, Cachay, Edward R, Currier, Judith S, Fukuta, Yuriko, Gerber, Jonathan M, Heath, Sonya L, Meisenberg, Barry, Huaman, Moises A, Levine, Adam C, Shenoy, Aarthi, Anjan, Shweta, Blair, Janis E, Cruser, Daniel, Forthal, Donald N, Hammitt, Laura L, Kassaye, Seble, Mosnaim, Giselle S, Patel, Bela, Paxton, James H, Raval, Jay S, Sutcliffe, Catherine G, Abinante, Matthew, Broderick, Patrick, Cluzet, Valerie, Cordisco, Marie Elena, Greenblatt, Benjamin, Petrini, Joann, Rausch, William, Shade, David, Lane, Karen, Gawad, Amy L, Klein, Sabra L, Pekosz, Andrew, Shoham, Shmuel, Casadevall, Arturo, Bloch, Evan M, Hanley, Daniel, Sullivan, David J, and Tobian, Aaron A R

Published
2023
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14. Diagnostic utility of whole genome sequencing in adults with B-other acute lymphoblastic leukemia

Author

Leongamornlert, Daniel, Gutiérrez-Abril, Jesús, Lee, SooWah, Barretta, Emilio, Creasey, Thomas, Gundem, Gunes, Levine, Max F., Arango-Ossa, Juan E., Liosis, Konstantinos, Medina-Martinez, Juan S., Zuborne Alapi, Krisztina, Kirkwood, Amy A., Clifton-Hadley, Laura, Patrick, Pip, Jones, David, O’Neill, Laura, Butler, Adam P., Harrison, Christine J., Campbell, Peter, Patel, Bela, Moorman, Anthony V., Fielding, Adele K., and Papaemmanuil, Elli

Published
2023
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15. Results from UKALL60+, a phase 2 study in older patients with untreated acute lymphoblastic leukemia

Author

Patel, Bela, primary, Kirkwood, Amy A., additional, Rowntree, Clare J., additional, Alapi, Krisztina Z., additional, Barretta, Emilio, additional, Clifton‐Hadley, Laura, additional, Creasey, Tom, additional, Lee, SooWah, additional, Marks, David I., additional, Moorman, Anthony V., additional, Morley, Nicholas, additional, Patrick, Pip, additional, Rana, Zaynab, additional, Rijneveld, Anita, additional, Snowden, John A., additional, and Fielding, Adele K., additional

Published
2024
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16. Convalescent plasma with a high level of virus-specific antibody effectively neutralizes SARS-CoV-2 variants of concern

Author

Li, Maggie, Beck, Evan J., Laeyendecker, Oliver, Eby, Yolanda, Tobian, Aaron A.R., Caturegli, Patrizio, Wouters, Camille, Chiklis, Gregory R., Block, William, McKie, Robert O., Joyner, Michael J., Wiltshire, Timothy D., Dietz, Allan B., Gniadek, Thomas J., Shapiro, Arell J., Yarava, Anusha, Lane, Karen, Hanley, Daniel F., Bloch, Evan M., Shoham, Shmuel, Cachay, Edward R., Meisenberg, Barry R., Huaman, Moises A., Fukuta, Yuriko, Patel, Bela, Heath, Sonya L., Levine, Adam C., Paxton, James H., Anjan, Shweta, Gerber, Jonathan M., Gebo, Kelly A., Casadevall, Arturo, Pekosz, Andrew, and Sullivan, David J.

Published
2022
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19. IKZF1 alterations are not associated with outcome in 498 adults with B-precursor ALL enrolled in the UKALL14 trial

Author

Mitchell, Rachel J., Kirkwood, Amy A., Barretta, Emilio, Clifton-Hadley, Laura, Lawrie, Emma, Lee, SooWah, Leongamornlert, Daniel, Marks, David I., McMillan, Andrew K., Menne, Tobias F., Papaemmanuil, Elli, Patel, Bela, Patrick, Pip, Rowntree, Clare J., Zareian, Nahid, Alapi, Krisztina Zuborne, Moorman, Anthony V., and Fielding, Adele K.

Published
2021
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22. 840. Risk-Based Screening on Admission Cultures (SOAC) vs. Unit-Wide Reactionary Surveillance Cultures (UWRC) for Candida auris: A Pilot QI Study in a Tertiary Care Center ICU

Author

Strong, Nora, primary, Patel, Bela, additional, Daniels, LaRhonda, additional, Ausborn, Valerie, additional, Mitchell, Elizabeth, additional, Denman, Chris, additional, Von Wenckstern, Toni, additional, Ellsworth, Misti G, additional, Ostrosky-Zeichner, Luis, additional, and Wanger, Audrey, additional

Published
2023
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23. 401. Risk of Post-COVID Conditions Correlates with IL-6 Plasma Levels and Is Reduced by Early Antibody Therapy

Author

Fukuta, Yuriko, primary, Gebo, Kelly, additional, Heath, Sonya L, additional, Zhu, Xianming, additional, Baksh, Sheriza, additional, Abraham, Alison G, additional, Habtehyimer, Feben, additional, Shade, David, additional, Ruff, Jessica E, additional, Ram, Malathi, additional, Laeyendecker, Oliver, additional, Fernandez, Reinaldo, additional, Patel, Eshan U, additional, Baker, Owen R, additional, Shoham, Shmuel, additional, Cachay, Edward R, additional, Currier, Judith S, additional, Gerber, Jonathan, additional, Meisenberg, Barry, additional, Hammitt, Laura, additional, Forthal, Donald, additional, Huaman, Moises A, additional, Levine, Adam C, additional, Mosnaim, Giselle, additional, Patel, Bela, additional, Paxton, James, additional, Raval, Jay S, additional, Sutcliffe, Catherine, additional, Anjan, Shweta, additional, Gniadek, Thomas, additional, Kassaye, Seble, additional, Blair, Janis E, additional, Lane, Karen, additional, McBee, Nichol, additional, Gawad, Amy, additional, Das, Piyali, additional, Klein, Sabra L, additional, Pekosz, Andrew, additional, Bloch, Evan, additional, Hanley, Daniel, additional, Casadevall, Arturo, additional, Tobian, Aaron, additional, and Sullivan, David, additional

Published
2023
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24. COVID-19 convalescent plasma therapy decreases inflammatory cytokines: a randomized controlled trial

Author

Habtehyimer, Feben, primary, Zhu, Xianming, additional, Redd, Andrew D., additional, Gebo, Kelly A., additional, Abraham, Alison G., additional, Patel, Eshan U., additional, Laeyendecker, Oliver, additional, Gniadek, Thomas J., additional, Fernandez, Reinaldo E., additional, Baker, Owen R., additional, Ram, Malathi, additional, Cachay, Edward R., additional, Currier, Judith S., additional, Fukuta, Yuriko, additional, Gerber, Jonathan M., additional, Heath, Sonya L., additional, Meisenberg, Barry, additional, Huaman, Moises A., additional, Levine, Adam C., additional, Shenoy, Aarthi, additional, Anjan, Shweta, additional, Blair, Janis E., additional, Cruser, Daniel, additional, Forthal, Donald N., additional, Hammitt, Laura L., additional, Kassaye, Seble, additional, Mosnaim, Giselle S., additional, Patel, Bela, additional, Paxton, James H., additional, Raval, Jay S., additional, Sutcliffe, Catherine G., additional, Abinante, Matthew, additional, Oei, Kevin S., additional, Cluzet, Valerie, additional, Cordisco, Marie Elena, additional, Greenblatt, Benjamin, additional, Rausch, William, additional, Shade, David, additional, Gawad, Amy L., additional, Klein, Sabra L., additional, Pekosz, Andrew, additional, Shoham, Shmuel, additional, Casadevall, Arturo, additional, Bloch, Evan M., additional, Hanley, Daniel, additional, Tobian, Aaron A. R., additional, and Sullivan, David J., additional

Published
2023
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25. COVID-19 Convalescent Plasma Outpatient Therapy to Prevent Outpatient Hospitalization

Author

Levine, Adam C, Fukuta, Yuriko, Huaman, Moises A, Ou, Jiangda, Meisenberg, Barry R, Patel, Bela, Paxton, James H, Hanley, Daniel F, Rijnders, Bart Ja, Gharbharan, Arvind, Rokx, Casper, Zwaginga, Jaap Jan, Alemany, Andrea, Mitjà, Oriol, Ouchi, Dan, Millat-Martinez, Pere, Durkalski-Mauldin, Valerie, Korley, Frederick K, Dumont, Larry J, Callaway, Clifton W, Libster, Romina, Marc, Gonzalo Perez, Wappner, Diego, Esteban, Ignacio, Polack, Fernando, Sullivan, David J, Internal Medicine, Surgery, and Medical Microbiology & Infectious Diseases

Subjects
Microbiology (medical), Infectious Diseases
Abstract

Background Outpatient monoclonal antibodies are no longer effective and antiviral treatments for coronavirus disease 2019 (COVID-19) disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma (CCP) is promising, clinical trials among outpatients have shown mixed results. Methods We conducted an individual participant data meta-analysis from outpatient trials to assess the overall risk reduction for all-cause hospitalizations by day 28 in transfused participants. Relevant trials were identified by searching Medline, Embase, medRxiv, World Health Organization COVID-19 Research Database, Cochrane Library, and Web of Science from January 2020 to September 2022. Results Five included studies from 4 countries enrolled and transfused 2620 adult patients. Comorbidities were present in 1795 (69%). The virus neutralizing antibody dilutional titer levels ranged from 8 to 14 580 in diverse assays. One hundred sixty of 1315 (12.2%) control patients were hospitalized, versus 111 of 1305 (8.5%) CCP-treated patients, yielding a 3.7% (95% confidence interval [CI], 1.3%–6.0%; P = .001) absolute risk reduction and 30.1% relative risk reduction for all-cause hospitalization. The hospitalization reduction was greatest in those with both early transfusion and high titer with a 7.6% absolute risk reduction (95% CI, 4.0%–11.1%; P = .0001) accompanied by at 51.4% relative risk reduction. No significant reduction in hospitalization was seen with treatment >5 days after symptom onset or in those receiving CCP with antibody titers below the median titer. Conclusions Among outpatients with COVID-19, treatment with CCP reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher.

Published
2023

26. Efficacy and safety of MAS825 (anti-IL-1β/IL-18) in COVID-19 patients with pneumonia and impaired respiratory function

Author

Hakim, Alex D, primary, Awili, Mustafa, additional, O’Neal, Hollis R, additional, Siddiqi, Omar, additional, Jaffrani, Naseem, additional, Lee, Richard, additional, Overcash, Jeffrey S, additional, Chauffe, Ann, additional, Hammond, Terese C, additional, Patel, Bela, additional, Waters, Michael, additional, Criner, Gerard J, additional, Pachori, Alok, additional, Junge, Guido, additional, Levitch, Rafael, additional, Watts, Jen, additional, Koo, Philip, additional, Sengupta, Tirtha, additional, Yu, Lili, additional, Kiffe, Michael, additional, Pinck, Anne, additional, Stein, Richard R, additional, Bendrick-Peart, Jamie, additional, Jenkins, Janet, additional, Rowlands, Marianna, additional, Waldron-Lynch, Frank, additional, and Matthews, Jesse, additional

Published
2023
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27. Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial.

Author

Shoham, Shmuel, Shoham, Shmuel, Bloch, Evan M, Casadevall, Arturo, Hanley, Daniel, Lau, Bryan, Gebo, Kelly, Cachay, Edward, Kassaye, Seble G, Paxton, James H, Gerber, Jonathan, Levine, Adam C, Naeim, Arash, Currier, Judith, Patel, Bela, Allen, Elizabeth S, Anjan, Shweta, Appel, Lawrence, Baksh, Sheriza, Blair, Paul W, Bowen, Anthony, Broderick, Patrick, Caputo, Christopher A, Cluzet, Valerie, Cordisco, Marie Elena, Cruser, Daniel, Ehrhardt, Stephan, Forthal, Donald, Fukuta, Yuriko, Gawad, Amy L, Gniadek, Thomas, Hammel, Jean, Huaman, Moises A, Jabs, Douglas A, Jedlicka, Anne, Karlen, Nicky, Klein, Sabra, Laeyendecker, Oliver, Lane, Karen, McBee, Nichol, Meisenberg, Barry, Merlo, Christian, Mosnaim, Giselle, Park, Han-Sol, Pekosz, Andrew, Petrini, Joann, Rausch, William, Shade, David M, Shapiro, Janna R, Singleton, J Robinson, Sutcliffe, Catherine, Thomas, David L, Yarava, Anusha, Zand, Martin, Zenilman, Jonathan M, Tobian, Aaron AR, Sullivan, David J, Shoham, Shmuel, Shoham, Shmuel, Bloch, Evan M, Casadevall, Arturo, Hanley, Daniel, Lau, Bryan, Gebo, Kelly, Cachay, Edward, Kassaye, Seble G, Paxton, James H, Gerber, Jonathan, Levine, Adam C, Naeim, Arash, Currier, Judith, Patel, Bela, Allen, Elizabeth S, Anjan, Shweta, Appel, Lawrence, Baksh, Sheriza, Blair, Paul W, Bowen, Anthony, Broderick, Patrick, Caputo, Christopher A, Cluzet, Valerie, Cordisco, Marie Elena, Cruser, Daniel, Ehrhardt, Stephan, Forthal, Donald, Fukuta, Yuriko, Gawad, Amy L, Gniadek, Thomas, Hammel, Jean, Huaman, Moises A, Jabs, Douglas A, Jedlicka, Anne, Karlen, Nicky, Klein, Sabra, Laeyendecker, Oliver, Lane, Karen, McBee, Nichol, Meisenberg, Barry, Merlo, Christian, Mosnaim, Giselle, Park, Han-Sol, Pekosz, Andrew, Petrini, Joann, Rausch, William, Shade, David M, Shapiro, Janna R, Singleton, J Robinson, Sutcliffe, Catherine, Thomas, David L, Yarava, Anusha, Zand, Martin, Zenilman, Jonathan M, Tobian, Aaron AR, and Sullivan, David J

Abstract

BackgroundThe efficacy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection.MethodsThis double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed coronavirus disease 2019 (COVID-19) in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was new SARS-CoV-2 infection.ResultsIn total, 180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for screening SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) positivity. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs 25.2 days; P = .49) and COVID-19 (26.3 vs 25.9 days; P = .35) was similar for both groups.ConclusionsAdministration of high-titer CCP as post-exposure prophylaxis, although appearing safe, did not prevent SARS-CoV-2 infection.Clinical trials registrationNCT04323800.

Published
2023

28. Coronavirus Disease 2019 Convalescent Plasma Outpatient Therapy to Prevent Outpatient Hospitalization:A Meta-analysis of Individual Participant Data From 5 Randomized Trials

Author

Levine, Adam C, Fukuta, Yuriko, Huaman, Moises A, Ou, Jiangda, Meisenberg, Barry R, Patel, Bela, Paxton, James H, Hanley, Daniel F, Rijnders, Bart Ja, Gharbharan, Arvind, Rokx, Casper, Zwaginga, Jaap Jan, Alemany, Andrea, Mitjà, Oriol, Ouchi, Dan, Millat-Martinez, Pere, Durkalski-Mauldin, Valerie, Korley, Frederick K, Dumont, Larry J, Callaway, Clifton W, Libster, Romina, Marc, Gonzalo Perez, Wappner, Diego, Esteban, Ignacio, Polack, Fernando, Sullivan, David J, Levine, Adam C, Fukuta, Yuriko, Huaman, Moises A, Ou, Jiangda, Meisenberg, Barry R, Patel, Bela, Paxton, James H, Hanley, Daniel F, Rijnders, Bart Ja, Gharbharan, Arvind, Rokx, Casper, Zwaginga, Jaap Jan, Alemany, Andrea, Mitjà, Oriol, Ouchi, Dan, Millat-Martinez, Pere, Durkalski-Mauldin, Valerie, Korley, Frederick K, Dumont, Larry J, Callaway, Clifton W, Libster, Romina, Marc, Gonzalo Perez, Wappner, Diego, Esteban, Ignacio, Polack, Fernando, and Sullivan, David J

Abstract

Background: Outpatient monoclonal antibodies are no longer effective and antiviral treatments for coronavirus disease 2019 (COVID-19) disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma (CCP) is promising, clinical trials among outpatients have shown mixed results. Methods: We conducted an individual participant data meta-analysis from outpatient trials to assess the overall risk reduction for all-cause hospitalizations by day 28 in transfused participants. Relevant trials were identified by searching Medline, Embase, medRxiv, World Health Organization COVID-19 Research Database, Cochrane Library, and Web of Science from January 2020 to September 2022. Results: Five included studies from 4 countries enrolled and transfused 2620 adult patients. Comorbidities were present in 1795 (69%). The virus neutralizing antibody dilutional titer levels ranged from 8 to 14 580 in diverse assays. One hundred sixty of 1315 (12.2%) control patients were hospitalized, versus 111 of 1305 (8.5%) CCP-treated patients, yielding a 3.7% (95% confidence interval [CI], 1.3%-6.0%; P =. 001) absolute risk reduction and 30.1% relative risk reduction for all-cause hospitalization. The hospitalization reduction was greatest in those with both early transfusion and high titer with a 7.6% absolute risk reduction (95% CI, 4.0%-11.1%; P =. 0001) accompanied by at 51.4% relative risk reduction. No significant reduction in hospitalization was seen with treatment >5 days after symptom onset or in those receiving CCP with antibody titers below the median titer. Conclusions: Among outpatients with COVID-19, treatment with CCP reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher.

Published
2023

30. Interstitial lung abnormalities after hospitalization for COVID‐19 in patients with cancer: A prospective cohort study.

Author

Noh, Sungryong, Bertini, Christopher, Mira‐Avendano, Isabel, Kaous, Maryam, Patel, Bela, Faiz, Saadia A., Shannon, Vickie R., Balachandran, Diwakar D., Bashoura, Lara, Adachi, Roberto, Evans, Scott E., Dickey, Burton, Wu, Carol, Shroff, Girish S., Manzano, Joanna‐Grace, Granwehr, Bruno, Holloway, Shannon, Dickson, Kodwo, Mohammed, Alyssa, and Muthu, Mayoora

Subjects
COVID-19, CANCER patients, COHORT analysis, LONGITUDINAL method, LUNGS, BRONCHIECTASIS, INTERSTITIAL lung diseases
Abstract

Introduction: Survivors of SARS‐CoV‐2 pneumonia often develop persistent respiratory symptom and interstitial lung abnormalities (ILAs) after infection. Risk factors for ILA development and duration of ILA persistence after SARS‐CoV‐2 infection are not well described in immunocompromised hosts, such as cancer patients. Methods: We conducted a prospective cohort study of 95 patients at a major cancer center and 45 patients at a tertiary referral center. We collected clinical and radiographic data during the index hospitalization for COVID‐19 pneumonia and measured pneumonia severity using a semi‐quantitative radiographic score, the Radiologic Severity Index (RSI). Patients were evaluated in post‐COVID‐19 clinics at 3 and 6 months after discharge and underwent comprehensive pulmonary evaluations (symptom assessment, chest computed tomography, pulmonary function tests, 6‐min walk test). The association of clinical and radiological factors with ILAs at 3 and 6 months post‐discharge was measured using univariable and multivariable logistic regression. Results: Sixty‐six (70%) patients of cancer cohort had ILAs at 3 months, of whom 39 had persistent respiratory symptoms. Twenty‐four (26%) patients had persistent ILA at 6 months after hospital discharge. In adjusted models, higher peak RSI at admission was associated with ILAs at 3 (OR 1.5 per 5‐point increase, 95% CI 1.1–1.9) and 6 months (OR 1.3 per 5‐point increase, 95% CI 1.1–1.6) post‐discharge. Fibrotic ILAs (reticulation, traction bronchiectasis, and architectural distortion) were more common at 6 months post‐discharge. Conclusions: Post‐COVID‐19 ILAs are common in cancer patients 3 months after hospital discharge, and peak RSI and older age are strong predictors of persistent ILAs. [ABSTRACT FROM AUTHOR]

Published
2023
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31. Early Treatment, Inflammation and Post-COVID Conditions

Author

Gebo, Kelly A., Heath, Sonya L., Fukuta, Yuriko, Zhu, Xianming, Baksh, Sheriza, Abraham, Alison G., Habtehyimer, Feben, Shade, David, Ruff, Jessica, Ram, Malathi, Laeyendecker, Oliver, Fernandez, Reinaldo E., Patel, Eshan U., Baker, Owen R., Shoham, Shmuel, Cachay, Edward R., Currier, Judith S., Gerber, Jonathan M., Meisenberg, Barry, Forthal, Donald N., Hammitt, Laura L., Huaman, Moises A., Levine, Adam, Mosnaim, Giselle S., Patel, Bela, Paxton, James H., Raval, Jay S., Sutcliffe, Catherine G., Anjan, Shweta, Gniadek, Thomas, Kassaye, Seble, Blair, Janis E., Lane, Karen, McBee, Nichol A., Gawad, Amy L., Das, Piyali, Klein, Sabra L., Pekosz, Andrew, Casadevall, Arturo, Bloch, Evan M., Hanley, Daniel, Tobian, Aaron A.R., and Sullivan, David J.

Subjects
Article
Abstract

BackgroundPost-COVID conditions (PCC) are common and have significant morbidity. Risk factors for PCC include advancing age, female sex, obesity, and diabetes mellitus. Little is known about early treatment, inflammation, and PCC.MethodsAmong 883 individuals with confirmed SARS-CoV-2 infection participating in a randomized trial of CCP vs. control plasma with available biospecimens and symptom data, the association between early COVID treatment, cytokine levels and PCC was evaluated. Cytokine and chemokine levels were assessed at baseline, day 14 and day 90 using a multiplexed sandwich immuosassay (Mesoscale Discovery). Presence of any self-reported PCC symptoms was assessed at day 90. Associations between COVID treatment, cytokine levels and PCC were examined using multivariate logistic regression models.ResultsOne-third of the 882 participants had day 90 PCC symptoms, with fatigue (14.5%) and loss of smell (14.5%) being most common. Cytokine levels decreased from baseline to day 90. In a multivariable analysis including diabetes, body mass index, race, and vaccine status, female sex (adjusted odds ratio[AOR]=2.70[1.93-3.81]), older age (AOR=1.32[1.17-1.50]), and elevated baseline levels of IL-6 (AOR=1.59[1.02-2.47]) were associated with development of PCC. There was a trend for decreased PCC in those with early CCP treatment (<5 days after symptom onset) compared to late CCP treatment.ConclusionIncreased IL-6 levels were associated with the development of PCC and there was a trend for decreased PCC with early CCP treatment in this predominately unvaccinated population. Future treatment studies should evaluate the effect of early treatment and anti-IL-6 therapies on PCC development.SummaryIncreased IL-6 levels were associated with the development of Post-COVID Conditions (PCC) and there was a trend for decreased PCC with early COVID convalescent plasma treatment in this predominately unvaccinated population.

Published
2023

32. Inhibition of Stearoyl-CoA Desaturase Has Anti-Leukemic Properties in Acute Myeloid Leukemia

Author

Dembitz, Vilma, primary, Lawson, Hannah, additional, Philippe, Celine, additional, Burt, Richard J., additional, James, Sophie, additional, Magee, Aoife S.M., additional, Woodley, Keith, additional, Durko, Jozef, additional, Campos, Joana, additional, Austin, Michael James, additional, Rio-Machin, Ana, additional, Casado Izquierdo, Pedro, additional, Bewicke-Copley, Findlay, additional, Rodriguez Blanco, Giovanny, additional, Patel, Bela, additional, Hazlehurst, Lori, additional, Peck, Barrie, additional, Finch, Andrew, additional, Cutillas, Pedro, additional, Fitzgibbon, Jude, additional, Yuneva, Mariia, additional, Rouault-Pierre, Kevin, additional, Copland, John, additional, Kranc, Kamil, additional, and Gallipoli, Paolo, additional

Published
2022
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35. In-vivo T-cell depleted reduced-intensity conditioned allogeneic haematopoietic stem-cell transplantation for patients with acute lymphoblastic leukaemia in first remission: results from the prospective, single-arm evaluation of the UKALL14 trial

Author

Marks, David I., Clifton-Hadley, Laura, Copland, Mhairi, Hussain, Jiaull, Menne, Tobias F., McMillan, Andrew, Moorman, Anthony V., Morley, Nicholas, Okasha, Dina, Patel, Bela, Patrick, Pip, Potter, Michael N., Rowntree, Clare J., Kirkwood, Amy A., and Fielding, Adele K.

Subjects
Adult, Male, Epstein-Barr Virus Infections, Herpesvirus 4, Human, T-Lymphocytes, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Humans, Female, Prospective Studies, Neoplasm Recurrence, Local, Unrelated Donors, Aged
Abstract

Background:\ud The outcome of chemotherapy in patients older than 40 years with acute lymphoblastic leukaemia is poor and myeloablative allogeneic haematopoietic stem-cell transplantation (HSCT) has a high transplant-related mortality (TRM) in this age cohort. The aim of this study was to assess the activity and safety of reduced-intensity conditioned allogeneic HSCT in this patient population.\ud \ud Methods:\ud This was a single-arm, prospective study within the UKALL14 trial done in 46 centres in the UK, which recruited patients to the transplantation substudy. Participants in UKALL14 had B-cell or T-cell acute lymphoblastic leukaemia, were aged 25–65 years (BCR-ABL1-negative) or 18–65 years (BCR-ABL1-positive), and for this subcohort had a fit, matched sibling donor or an 8 out of 8 allelic matched unrelated donor (HLA-A, HLA-B, HLA-C, and HLA-DR). On June 20, 2014, the protocol was amended to allow 7 out of 8 matched unrelated donors if the patient had high risk cytogenetics or was minimal residual disease (MRD)-positive after the second induction course. Patients were given fludarabine, melphalan, and alemtuzumab (FMA; intravenous fludarabine 30 mg/m2 on days –6 to –2, melphalan 140 mg/m2 on day –2, and alemtuzumab 30 mg on day –1 [sibling donor] and days –2 and –1 [unrelated donor]) before allogeneic HSCT (aged ≥41 years patient pathway). Donor lymphocyte infusions were given from 6 months for mixed chimerism or MRD. The primary endpoint was event-free survival and secondary and transplantation-specific endpoints included overall survival, relapse incidence, TRM, and acute and chronic graft-versus-host disease (GVHD). This study is registered with ClinicalTrials.gov, NCT01085617.\ud \ud Findings:\ud From Feb 22, 2011, to July 26, 2018, 249 patients (236 aged ≥41 years and 13 younger than 41 years) considered unfit for a myeloablative allograft received an FMA reduced-intensity conditioned HSCT. 138 (55%) patients were male and 111 (45%) were female. 88 (35%) participants received transplantations from a sibling donor and 160 (64%) received transplantations from unrelated donors. 211 (85%) participants had B-precursor acute lymphoblastic leukaemia. High-risk cytogenetics were present in 43 (22%) and another 63 (25%) participants were BCR-ABL1-positive. At median follow-up of 49 months (IQR 36–70), 4-year event-free survival was 46·8% (95% CI 40·1–53·2) and 4-year overall survival was 54·8% (48·0–61·2). 4-year cumulative incidence of relapse was 33·6% (27·9–40·2) and 4-year TRM was 19·6% (15·1–25·3). 27 (56%) of 48 patients with TRM had infection as the named cause of death. Seven (15%) of 48 patients had fungal infections, 13 (27%) patients had bacterial infections (six gram-negative), and 11 (23%) had viral infections (three cytomegalovirus and two Epstein-Barr virus). Acute GVHD grade 2–4 occurred in 29 (12%) of 247 patients and grade 3–4 occurred in 12 (5%) patients. Chronic GVHD incidence was 84 (37%) of 228 patients (50 [22%] had extensive chronic GVHD). 49 (30%) of 162 patients had detectable end-of-induction MRD, which portended worse outcomes with event-free survival (HR 2·40 [95% CI 1·46–3·93]) and time-to-relapse (HR 2·41 [1·29–4·48]).\ud \ud Interpretation:\ud FMA reduced-intensity conditioned allogeneic HSCT in older patients with acute lymphoblastic leukaemia in first complete remission provided good disease control with moderate GVHD, resulting in better-than-expected event-free survival and overall survival in this high-risk population. Strategies to reduce infection-related TRM will further improve outcomes.

Published
2022

37. Adaptive immune responses in vaccinated patients with symptomatic SARS-CoV-2 Alpha infection

Author

Park, Han-Sol, primary, Shapiro, Janna R., additional, Sitaras, Ioannis, additional, Woldemeskel, Bezawit A., additional, Garliss, Caroline C., additional, Dziedzic, Amanda, additional, Sachithanandham, Jaiprasath, additional, Jedlicka, Anne E., additional, Caputo, Christopher A., additional, Rousseau, Kimberly E., additional, Thakar, Manjusha, additional, Suwanmanee, San, additional, Hauk, Pricila, additional, Aliyu, Lateef, additional, Majewska, Natalia I., additional, Koley, Sushmita, additional, Patel, Bela, additional, Broderick, Patrick, additional, Mosnaim, Giselle, additional, Heath, Sonya L., additional, Spivak, Emily S., additional, Shenoy, Aarthi, additional, Bloch, Evan M., additional, Gniadek, Thomas J., additional, Shoham, Shmuel, additional, Casadevall, Arturo, additional, Hanley, Daniel, additional, Cox, Andrea L., additional, Laeyendecker, Oliver, additional, Betenbaugh, Michael J., additional, Cramer, Steven M., additional, Mostafa, Heba H., additional, Pekosz, Andrew, additional, Blankson, Joel N., additional, Klein, Sabra L., additional, Tobian, Aaron A.R., additional, Sullivan, David, additional, and Gebo, Kelly A., additional

Published
2022
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38. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients

Author

Ortigoza, Mila B., Yoon, Hyunah, Goldfeld, Keith S., Troxel, Andrea B., Daily, Johanna P., Wu, Yinxiang, Li, Yi, Wu, Danni, Cobb, Gia F., Baptiste, Gillian, O’Keeffe, Mary, Corpuz, Marilou O., Ostrosky-Zeichner, Luis, Amin, Amee, Zacharioudakis, Ioannis M., Jayaweera, Dushyantha T., Wu, Yanyun, Philley, Julie V., Devine, Megan S., Desruisseaux, Mahalia S., Santin, Alessandro D., Anjan, Shweta, Mathew, Reeba, Patel, Bela, Nigo, Masayuki, Upadhyay, Rabi, Kupferman, Tania, Dentino, Andrew N., Nanchal, Rahul, Merlo, Christian A., Hager, David N., Chandran, Kartik, Lai, Jonathan R., Rivera, Johanna, Bikash, Chowdhury R., Lasso, Gorka, Hilbert, Timothy P., Paroder, Monika, Asencio, Andrea A., Liu, Mengling, Petkova, Eva, Bragat, Alexander, Shaker, Reza, McPherson, David D., Sacco, Ralph L., Keller, Marla J., Grudzen, Corita R., Hochman, Judith S., Pirofski, Liise-anne, Parameswaran, Lalitha, Corcoran, Anthony T., Rohatgi, Abhinav, Wronska, Marta W., Wu, Xinyuan, Srinivasan, Ranjini, Deng, Fang-Ming, Filardo, Thomas D., Pendse, Jay, Blaser, Simone B., Whyte, Olga, Gallagher, Jacqueline M., Thomas, Ololade E., Ramos, Danibel, Sturm-Reganato, Caroline L., Fong, Charlotte C., Daus, Ivy M., Payoen, Arianne Gisselle, Chiofolo, Joseph T., Friedman, Mark T., Wu, Ding Wen, Jacobson, Jessica L., Schneider, Jeffrey G., Sarwar, Uzma N., Wang, Henry E., Huebinger, Ryan M., Dronavalli, Goutham, Bai, Yu, Grimes, Carolyn Z., Eldin, Karen W., Umana, Virginia E, Martin, Jessica G., Heath, Timothy R., Bello, Fatimah O., Ransford, Daru Lane, Laurent-Rolle, Maudry, Shenoi, Sheela V., Akide-Ndunge, Oscar Bate, Thapa, Bipin, Peterson, Jennifer L., Knauf, Kelly, Patel, Shivani U., Cheney, Laura L., Tormey, Christopher A., and Hendrickson, Jeanne E.

Subjects
musculoskeletal diseases, Adult, Male, Research, Critical Illness, Immunization, Passive, COVID-19, Blood Component Transfusion, Middle Aged, Respiration, Artificial, United States, Hospitalization, Treatment Outcome, Double-Blind Method, immune system diseases, Online First, Humans, Female, skin and connective tissue diseases, COVID-19 Serotherapy, Original Investigation, Aged
Abstract

Key Points Question Does COVID-19 convalescent plasma (CCP), compared with placebo, improve the clinical status of hospitalized patients with COVID-19 requiring noninvasive supplemental oxygen? Findings In this randomized clinical trial including 941 patients, based on the World Health Organization 11-point Ordinal Scale for Clinical Improvement, CCP did not benefit 468 participants randomized to CCP compared with 473 randomized to placebo from April 2020 to March 2021. However, in exploratory analyses, CCP appeared to benefit those enrolled from April to June 2020, the period when most participants received high-titer CCP and were not receiving remdesivir and corticosteroids at randomization. Meaning In this trial, CCP did not meet prespecified outcomes for efficacy, but high-titer CCP may have benefited hospitalized patients with COVID-19 early in the pandemic when other treatments were not in use, suggesting a heterogenous treatment effect over time., Importance There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR, This randomized clinical trial examines the use of convalescent plasma from patients with COVID-19 in hospitalized patients with COVID-19 who are not receiving invasive oxygenation treatment.

Published
2021

40. Genetic and genomic analysis of acute lymphoblastic leukemia in older adults reveals a distinct profile of abnormalities: analysis of 210 patients from the UKALL14 and UKALL60+ clinical trials

Author

Creasey, Thomas, primary, Barretta, Emilio, additional, Ryan, Sarra L., additional, Butler, Ellie, additional, Kirkwood, Amy A., additional, Leongamornlert, Daniel, additional, Papaemmanuil, Elli, additional, Patrick, Pip, additional, Clifton-Hadley, Laura, additional, Patel, Bela, additional, Menne, Tobias, additional, McMillan, Andrew K., additional, Harrison, Christine J., additional, Rowntree, Clare J., additional, Morley, Nick, additional, Marks, David I., additional, Fielding, Adele K., additional, and Moorman, Anthony V., additional

Published
2021
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44. Extended Thromboprophylaxis in Patients Hospitalized with COVID-19 at Time of Discharge from the Hospital Is Not Associated with an Improvement in Quality of Life: Results from the Activ 4c Clinical Trial

Author

Baumann Kreuziger, Lisa, Kwon, Taeim, Wahid, Lana, Kasthuri, Raj S., Kindzelski, Andrei L., Knudson, M. Margaret, Krishnan, Jerry, Lamas, Gervasio, Leifere, Eric, Lopez-Sendon, Jose, Miller, Peter J, Patel, Bela, Weissman, Alexandra J, Quigley, John, Siegal, Deborah, Wang, Tracy Y, Anstrom, Kevin J, and Ortel, Thomas L.

Published
2023
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46. Molecular classification improves risk assessment in adult BCR-ABL1–negative B-ALL

Author

Paietta, Elisabeth, primary, Roberts, Kathryn G., additional, Wang, Victoria, additional, Gu, Zhaohui, additional, Buck, Georgina A. N., additional, Pei, Deqing, additional, Cheng, Cheng, additional, Levine, Ross L., additional, Abdel-Wahab, Omar, additional, Cheng, Zhongshan, additional, Wu, Gang, additional, Qu, Chunxu, additional, Shi, Lei, additional, Pounds, Stanley, additional, Willman, Cheryl L., additional, Harvey, Richard, additional, Racevskis, Janis, additional, Barinka, Jan, additional, Zhang, Yanming, additional, Dewald, Gordon W., additional, Ketterling, Rhett P., additional, Alejos, David, additional, Lazarus, Hillard M., additional, Luger, Selina M., additional, Foroni, Letizia, additional, Patel, Bela, additional, Fielding, Adele K., additional, Melnick, Ari, additional, Marks, David I., additional, Moorman, Anthony V., additional, Wiernik, Peter H., additional, Rowe, Jacob M., additional, Tallman, Martin S., additional, Goldstone, Anthony H., additional, Mullighan, Charles G., additional, and Litzow, Mark R., additional

Published
2021
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48. Analysis of polysomal mRNA populations of mouse oocytes and zygotes: Dynamic changes in maternal mRNA utilization and function

Author

Potireddy, Santhi, Vassena, Rita, Patel, Bela G., and Latham, Keith E.

Subjects
DNA microarrays -- Research, Genomics -- Research, Messenger RNA -- Research, Oocytes -- Research, Mice -- Research, Biological sciences
Abstract

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ydbio.2006.06.024 Byline: Santhi Potireddy (b), Rita Vassena (a), Bela G. Patel (a), Keith E. Latham (a)(b) Keywords: Embryo; Oocyte; Translation; Polysome; Microarray; Maternal mRNA; CPE Abbreviations: MmRNA, maternal mRNA; MGA, major genome activation; CPE, cytoplasmic polyadenylation element; PRE, polyadenylation response element Abstract: Transcriptional activation in mammalian embryos occurs in a stepwise manner. In mice, it begins at the late one-cell stage, followed by a minor wave of activation at the early two-cell stage, and then the major genome activation event (MGA) at the late two-cell stage. Cellular homeostasis, metabolism, cell cycle, and developmental events are orchestrated before MGA by time-dependent changes in the array of maternal transcripts being translated. Many elegant studies have documented the importance of maternal mRNA (MmRNA) and its correct recruitment for development. Many other studies have illuminated some of the molecular mechanisms regulating MmRNA utilization. However, neither the complete array of recruited mRNAs nor the regulatory mechanisms responsible for temporally different patterns of recruitment have been well characterized. We present a comprehensive analysis of changes in the maternal component of the zygotic polysomal mRNA population during the transition from oocyte to late one-cell stage embryo. We observe global transitions in the functional classes of translated MmRNAs and apparent changes in the underlying cis-regulatory mechanisms. Author Affiliation: (a) The Fels Institute for Cancer Research and Molecular Biology, Temple University School of Medicine, 3307 N. Broad Street, Philadelphia, PA 19140, USA (b) The Department of Biochemistry, Temple University School of Medicine, 3420 N. Broad Street, Philadelphia, PA 19140, USA Article History: Received 23 February 2006; Revised 12 June 2006; Accepted 14 June 2006 Article Note: (footnote) [star] Microarray tabular data are deposited at http://www.ncbi.nlm.nih.gov/projects/geo/, data set accession number: GSE3962.

Published
2006

49. To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias.

Author

Haertter, Sebastian, Kanodia, Jitendar, Cook, Jack, Alicea, Jeanette, Brennan, Bonnie J., Desai, Amit, Patel, Bela, Pan, Lin, and Goteti, Kosalaram

Subjects
CLINICAL trials, CLINICAL pharmacology, DRUG development, PHARMACEUTICAL industry
Abstract

An IQ consortium working group (WG) conducted a survey across multiple biopharmaceutical companies to gain information about the level of blinding commonly utilized for early clinical development trials. The main objectives were: (1) to understand blinding practices between healthy volunteer (HV) and early explorative patient trials in all therapeutic areas except oncology where early clinical trials are commonly open‐label; (2) to understand the rationale for blinding/unblinding practices; (3) to understand the groups and personnel involved in unblinding; and (4) strategic considerations around blinding/unblinding options in early clinical development trials—risk of bias vs. potential for acceleration. A survey containing 31 main questions with additional sub‐clarifying questions was conducted. Sixteen large and mid‐size pharmaceutical companies responded. Responses were aligned across functions within each participating company. Additional information was gathered at an American Association of Pharmaceutical Scientists (AAPS) webinar with polling options to roughly 550 registered attendees to evaluate the reason for the unblinding decisions. The results revealed divergence across companies in the blinding approaches most commonly applied but with some study types, there were clearly favored options. Based on these results, the WG developed strategic considerations for first‐in‐human HV trials and nonpivotal explorative trials in patients. This paper should facilitate discussions among various clinical development functions, such as Clinical Pharmacology, Statistics, Clinical, Bioanalytics, and Regulatory Functions. Such discussions on study design and operations are warranted to allow implementation of more flexible blinding approaches to accelerate data driven decisions in drug development and allow earlier access of patients to needful medicines. [ABSTRACT FROM AUTHOR]

Published
2022
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