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1. The Association of Baseline Plasma SARS-CoV-2 Nucleocapsid Antigen Level and Outcomes in Patients Hospitalized With COVID-19

Author

Rogers, Angela J, Wentworth, Deborah, Phillips, Andrew, Shaw-Saliba, Katy, Dewar, Robin L, Aggarwal, Neil R, Babiker, Abdel G, Chang, Weizhong, Dharan, Nila J, Davey, Victoria J, Higgs, Elizabeth S, Gerry, Norman, Ginde, Adit A, Hayanga, JW Awori, Highbarger, Helene, Highbarger, Jeroen L, Jain, Mamta K, Kan, Virginia, Kim, Kami, Lallemand, Perrine, Leshnower, Bradley G, Lutaakome, Joseph K, Matthews, Gail, Mourad, Ahmad, Mylonakis, Eleftherios, Natarajan, Ven, Padilla, Maria L, Pandit, Lavannya M, Paredes, Roger, Pett, Sarah, Ramachandruni, Srikanth, Rehman, M Tauseef, Sherman, Brad T, Files, D Clark, Brown, Samuel M, Matthay, Michael A, Thompson, B Taylor, Neaton, James D, Lane, H Clifford, Lundgren, Jens D, 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, and Barrett, Kevin

Subjects
Prevention, Vaccine Related, Emerging Infectious Diseases, Infectious Diseases, Clinical Research, Lung, Biodefense, Inflammatory and immune system, Infection, Good Health and Well Being, Adult, COVID-19, Cross-Sectional Studies, Humans, Male, Nucleocapsid, SARS-CoV-2, ACTIV-3/TICO Study Group, Clinical Sciences, Public Health and Health Services
Abstract

BackgroundLevels of plasma SARS-CoV-2 nucleocapsid (N) antigen may be an important biomarker in patients with COVID-19 and enhance our understanding of the pathogenesis of COVID-19.ObjectiveTo evaluate whether levels of plasma antigen can predict short-term clinical outcomes and identify clinical and viral factors associated with plasma antigen levels in hospitalized patients with SARS-CoV-2.DesignCross-sectional study of baseline plasma antigen level from 2540 participants enrolled in the TICO (Therapeutics for Inpatients With COVID-19) platform trial from August 2020 to November 2021, with additional data on day 5 outcome and time to discharge.Setting114 centers in 10 countries.ParticipantsAdults hospitalized for acute SARS-CoV-2 infection with 12 days or less of symptoms.MeasurementsBaseline plasma viral N antigen level was measured at a central laboratory. Delta variant status was determined from baseline nasal swabs using reverse transcriptase polymerase chain reaction. Associations between baseline patient characteristics and viral factors and baseline plasma antigen levels were assessed using both unadjusted and multivariable modeling. Association between elevated baseline antigen level of 1000 ng/L or greater and outcomes, including worsening of ordinal pulmonary scale at day 5 and time to hospital discharge, were evaluated using logistic regression and Fine-Gray regression models, respectively.ResultsPlasma antigen was below the level of quantification in 5% of participants at enrollment, and 1000 ng/L or greater in 57%. Baseline pulmonary severity of illness was strongly associated with plasma antigen level, with mean plasma antigen level 3.10-fold higher among those requiring noninvasive ventilation or high-flow nasal cannula compared with room air (95% CI, 2.22 to 4.34). Plasma antigen level was higher in those who lacked antispike antibodies (6.42 fold; CI, 5.37 to 7.66) and in those with the Delta variant (1.73 fold; CI, 1.41 to 2.13). Additional factors associated with higher baseline antigen level included male sex, shorter time since hospital admission, decreased days of remdesivir, and renal impairment. In contrast, race, ethnicity, body mass index, and immunocompromising conditions were not associated with plasma antigen levels. Plasma antigen level of 1000 ng/L or greater was associated with a markedly higher odds of worsened pulmonary status at day 5 (odds ratio, 5.06 [CI, 3.41 to 7.50]) and longer time to hospital discharge (median, 7 vs. 4 days; subhazard ratio, 0.51 [CI, 0.45 to 0.57]), with subhazard ratios similar across all levels of baseline pulmonary severity.LimitationsPlasma samples were drawn at enrollment, not hospital presentation. No point-of-care test to measure plasma antigen is currently available.ConclusionElevated plasma antigen is highly associated with both severity of pulmonary illness and clinically important patient outcomes. Multiple clinical and viral factors are associated with plasma antigen level at presentation. These data support a potential role of ongoing viral replication in the pathogenesis of SARS-CoV-2 in hospitalized patients.Primary funding sourceU.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.

Published
2022

2. Evaluating Primary Endpoints for COVID-19 Therapeutic Trials to Assess Recovery.

Author

Douin, David J, Siegel, Lianne, Grandits, Greg, Phillips, Andrew, Aggarwal, Neil R, Baker, Jason, Brown, Samuel M, Chang, Christina C, Goodman, Anna L, Grund, Birgit, Higgs, Elizabeth S, Hough, Catherine L, Murray, Daniel D, Paredes, Roger, Parmar, Mahesh, Pett, Sarah, Polizzotto, Mark N, Sandkovsky, Uriel, Self, Wesley H, Young, Barnaby E, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Gelijns, Annetine C, Matthews, Gail, Thompson, B Taylor, Lane, H Clifford, Neaton, James D, Lundgren, Jens D, and Ginde, Adit A

Subjects
Humans, Antibodies, Monoclonal, Treatment Outcome, Aftercare, Patient Discharge, Aged, COVID-19, SARS-CoV-2, monoclonal antibodies, outcomes assessment, Clinical Trials and Supportive Activities, Clinical Research, Good Health and Well Being, Medical and Health Sciences, Respiratory System
Abstract

Rationale: Uncertainty regarding the natural history of coronavirus disease (COVID-19) led to difficulty in efficacy endpoint selection for therapeutic trials. Capturing outcomes that occur after hospital discharge may improve assessment of clinical recovery among hospitalized patients with COVID-19. Objectives: Evaluate 90-day clinical course of patients hospitalized with COVID-19, comparing three distinct definitions of recovery. Methods: We used pooled data from three clinical trials of neutralizing monoclonal antibodies to compare: 1) the hospital discharge approach; 2) the TICO (Therapeutics for Inpatients with COVID-19) trials sustained recovery approach; and 3) a comprehensive approach. At the time of enrollment, all patients were hospitalized in a non-ICU setting without organ failure or major extrapulmonary manifestations of COVID-19. We defined discordance as a difference between time to recovery. Measurements and Main Results: Discordance between the hospital discharge and comprehensive approaches occurred in 170 (20%) of 850 enrolled participants, including 126 hospital readmissions and 24 deaths after initial hospital discharge. Discordant participants were older (median age, 68 vs. 59 years; P

Published
2022

3. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19

Author

Barkauskas, Christina, Mylonakis, Eleftherios, Poulakou, Garyfallia, Young, Barnaby E, Vock, David M, Siegel, Lianne, Engen, Nicole, Grandits, Greg, Mosaly, Nilima R, Vekstein, Andrew M, Rogers, Ralph, Shehadeh, Fadi, Kaczynski, Matthew, Mylona, Evangelia K, Syrigos, Konstantinos N, Rapti, Vasiliki, Lye, David C, Hui, Diong Shiau, Leither, Lindsay, Knowlton, Kirk U, Jain, Mamta K, Marines-Price, Rubria, Osuji, Alice, Overcash, J Scott, Kalomenidis, Ioannis, Barmparessou, Zafeiria, Waters, Michael, Zepeda, Karla, Chen, Peter, Torbati, Sam, Kiweewa, Francis, Sebudde, Nicholus, Almasri, Eyad, Hughes, Alyssa, Bhagani, Sanjay R, Rodger, Alison, Sandkovsky, Uriel, Gottlieb, Robert L, Nnakelu, Eriobu, Trautner, Barbara, Menon, Vidya, Lutaakome, Joseph, Matthay, Michael, Robinson, Philip, Protopapas, Konstantinos, Koulouris, Nikolaos, Kimuli, Ivan, Baduashvili, Amiran, Braun, Dominique L, Günthard, Huldrych F, Ramachandruni, Srikanth, Kidega, Robert, Kim, Kami, Hatlen, Timothy J, Phillips, Andrew N, Murray, Daniel D, Jensen, Tomas O, Padilla, Maria L, Accardi, Evan X, Shaw-Saliba, Katy, Dewar, Robin L, Teitelbaum, Marc, Natarajan, Ven, Laverdure, Sylvain, Highbarger, Helene C, Rehman, M Tauseef, Vogel, Susan, Vallée, David, Crew, Page, Atri, Negin, Schechner, Adam J, Pett, Sarah, Hudson, Fleur, Badrock, Jonathan, Touloumi, Giota, Brown, Samuel M, Self, Wesley H, North, Crystal M, Ginde, Adit A, Chang, Christina C, Kelleher, Anthony, Nagy-Agren, Stephanie, Vasudeva, Shikha, Looney, David, Nguyen, Hien H, Sánchez, Adriana, Weintrob, Amy C, Grund, Birgit, Sharma, Shweta, Reilly, Cavan S, Paredes, Roger, Bednarska, Agnieszka, Gerry, Norman P, Babiker, Abdel G, Davey, Victoria J, Gelijns, Annetine C, Higgs, Elizabeth S, Kan, Virginia, Matthews, Gail, and Thompson, B Taylor

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Lung, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Designed Ankyrin Repeat Proteins, Double-Blind Method, Humans, Recombinant Fusion Proteins, SARS-CoV-2, Treatment Outcome, COVID-19 Drug Treatment, ACTIV-3/TICO Study Group, Clinical Sciences, Public Health and Health Services
Abstract

BackgroundEnsovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.ObjectiveTo investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.DesignDouble-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).SettingMultinational, multicenter trial.ParticipantsAdults hospitalized with COVID-19.InterventionIntravenous ensovibep, 600 mg, or placebo.MeasurementsEnsovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90.ResultsAn independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR

Published
2022

4. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author

Group, ACTIV-3 Therapeutics for Inpatients with COVID-19 Study, Self, Wesley H, Sandkovsky, Uriel, Reilly, Cavan S, Vock, David M, Gottlieb, Robert L, Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R, Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R, Hibbert, Kathryn A, Rice, Todd W, Casey, Jonathan D, Hayanga, J Awori, Badhwar, Vinay, Leshnower, Bradley G, Sharifpour, Milad, Knowlton, Kirk U, Peltan, Ithan D, Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E, Sturek, Jeffrey M, Rogers, Angela J, Files, D Clark, Mosier, Jarrod M, Gong, Michelle N, Douin, David J, Hite, R Duncan, Trautner, Barbara W, Jain, Mamta K, Gardner, Edward M, Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A, Ginde, Adit A, Brown, Samuel M, Higgs, Elizabeth S, Pett, Sarah, Weintrob, Amy C, Chang, Christina C, Murrary, Daniel D, Günthard, Huldrych F, Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Thompson, B Taylor, Gelijns, Annetine C, Neaton, James D, Lane, H Clifford, Jundgren, Jens D, Tierney, John, Barrett, Kevin, Herpin, Betsey R, Smolskis, Mary C, Voge, Susan E, McNay, Laura A, Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J, Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, and Murray, Thomas

Subjects
Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Double-Blind Method, Female, Humans, Male, Middle Aged, SARS-CoV-2, Treatment Outcome, COVID-19 Drug Treatment, ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group, Clinical Sciences, Medical Microbiology, Public Health and Health Services, Microbiology
Abstract

BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed.

Published
2022

5. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, 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, Samantha, Wang, Samantha, 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, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford

Published
2023
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7. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Author

Ginde, Adit A., Paredes, Roger, Murray, Thomas A., Engen, Nicole, Grandits, Greg, Vekstein, Andrew, Ivey, Noel, Mourad, Ahmad, Sandkovsky, Uriel, Gottlieb, Robert L., Berhe, Mezgebe, Jain, Mamta K., Marines-Price, Rubria, Agbor Agbor, Barbine Tchamba, Mateu, Lourdes, España-Cueto, Sergio, Lladós, Gemma, Mylonakis, Eleftherios, Rogers, Ralph, Shehadeh, Fadi, Filbin, Michael R., Hibbert, Kathryn A., Kim, Kami, Tran, Thanh, Morris, Peter E., Cassity, Evan P., Trautner, Barbara, Pandit, Lavannya M., Knowlton, Kirk U., Leither, Lindsay, Matthay, Michael A., Rogers, Angela J., Drake, Wonder, Jones, Beatrice, Poulakou, Garyfallia, Syrigos, Konstantinos N., Fernández-Cruz, Eduardo, Natale, Marisa Di, Almasri, Eyad, Balerdi-Sarasola, Leire, Bhagani, Sanjay R., Boyle, Katherine L., Casey, Jonathan D., Chen, Peter, Douin, David J., Files, D. Clark, Günthard, Huldrych F., Hite, R. Duncan, Hyzy, Robert C., Khan, Akram, Kibirige, Moses, Kidega, Robert, Kiweewa, Francis, Jensen, Jens-Ulrik, Leshnower, Bradley G., Lutaakome, Joseph K., Manian, Prasad, Menon, Vidya, Morales-Rull, Jose Luis, O'Mahony, D. Shane, Overcash, J. Scott, Ramachandruni, Srikant, Steingrub, Jay S., Taha, Hassan S., Waters, Michael, Young, Barnaby E., Phillips, Andrew N., Murray, Daniel D., Jensen, Tomas O., Padilla, Maria L., Sahner, David, Shaw-Saliba, Katy, Dewar, Robin L., Teitelbaum, Marc, Natarajan, Ven, Rehman, M. Tauseef, Pett, Sarah, Hudson, Fleur, Touloumi, Giota, Brown, Samuel M., Self, Wesley H., Chang, Christina C., Sánchez, Adriana, Weintrob, Amy C., Hatlen, Timothy, Grund, Birgit, Sharma, Shweta, Reilly, Cavan S., Garbes, Pedro, Esser, Mark T., Templeton, Alison, Babiker, Abdel G., Davey, Victoria J., Gelijns, Annetine C., Higgs, Elizabeth S., Kan, Virginia, Matthews, Gail, Thompson, B. Taylor, Neaton, James D., Lane, H. Clifford, and Lundgren, Jens D.

Published
2022
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8. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author

Self, Wesley H., Sandkovsky, Uriel, Reilly, Cavan S., Vock, David M., Gottlieb, Robert L., Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R., Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R., Hibbert, Kathryn A., Rice, Todd W., Casey, Jonathan D., Hayanga, J. Awori, Badhwar, Vinay, Leshnower, Bradley G., Sharifpour, Milad, Knowlton, Kirk U., Peltan, Ithan D., Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E., Sturek, Jeffrey M., Rogers, Angela J., Files, D. Clark, Mosier, Jarrod M., Gong, Michelle N., Douin, David J., Hite, R. Duncan, Trautner, Barbara W., Jain, Mamta K., Gardner, Edward M., Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A., Ginde, Adit A., Brown, Samuel M., Higgs, Elizabeth S., Pett, Sarah, Weintrob, Amy C., Chang, Christina C., Murrary, Daniel D., Günthard, Huldrych F., Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N., Babiker, Abdel G., Davey, Victoria J., Kan, Virginia, Thompson, B. Taylor, Gelijns, Annetine C., Neaton, James D., Lane, H. Clifford, Jundgren, Jens D., Tierney, John, Barrett, Kevin, Herpin, Betsey R., Smolskis, Mary C., Voge, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J., Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, Murray, Thomas, Quan, Kien, Quan, Siu Fun, Thompson, Greg, Walski, Jamie, Wentworth, Deborah, Moskowitz, Alan J., Bagiella, Emilia, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Berhe, Mezgebe, Haley, Clinton, Bettacchi, Christopher, Duhaime, Erin, Ryan, Madison, Burris, Sarah, Jones, Felecia, Villa, Samantha, Want, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Marian, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Dreyer, Grace R., Witte, Marie, Mosaly, Nilima, Mourad, Ahmad, Holland, Thomas L., Lane, Kathleen, Bouffler, Andrew, McGowan, Lauren M., Motta, Marry, Tipton, Gregory, Stallings, Ben, Stout, Gennifer, McLendon-Arvik, Beth, Hollister, Beth A., Giangiacomo, Dana M., Sharma, Sunil, Pappers, Brian, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresio, Lisa, Glaze, Chad, Evans, Raquel, Preamble, Katarina, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Bartolo, Elizabeth Berry, Williams, Roger, Bunner, Robin, Bender, William, Miller, Jeffrey, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elizabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, May M., Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Lozano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Possemato, Tammie, Escobar, Jose, Chiu, Charlene, Weissman, Kevin, Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Jonathan, Vonderhaar, Derek, Nossaman, Bobby, Laudun, Sylvia, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Maroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberley, Audette, Matthew, Fleischmann, Emily, Akbari, Freshta, Lee, Maia, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Caccia, Taylor, Johnson, Haley, Newton, Crystallee, Parr, Doug, Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Fitzgerald, Laura, Morin, Haley D., Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Aggarwal, Neil R., Bienstock, Karen, Hou, Peter, Steingrub, Jay, Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Banner-Goodspeed, Valerie, Boyle, Katherine L., Hayes, Sharon, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah K., Parry, Blair Alden, Margolin, Justin D., Brait, Kelsey, Beakes, Caroline, Kangelaris, Kirsten N., Yee, Kimberly J., Ashktorab, Kimia, Jauregui, Alejandra E., Zhuo, Hanjing, Hendey, Gregory, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Wilson, Jennifer G., Vojnik, Rosemary, Roque, Jonasel, Perez, Cynthia, Lim, George W., Chang, Steven Y., Beutler, Rebecca, Agarwal, Trisha, Vargas, Julia, Moss, Marc, Baduashvili, Amiran, Chauhan, Lakshmi, Finck, Lani L., Howell, Michelle, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jia, Shijing, Sullins, Barbara, Hanna, Sinan, Olbrich, Norman, Richardson, Lynne D., Nair, Rahul, Offor, Obiageli, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Terndrup, Thomas E., Wiedemann, Herbert P., Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Hudock, Kristin, Kiran, Simra, More, Harshada, Roads, Tammy, Martinkovic, Jamie, Kennedy, Sarah, Robinson, Bryce H., Hough, Catherine L., Krol, Olivia F., Kinjal, Mistry, Mills, Emmanuel, McDougal, Madeline, Deshmukh, Rupali, Chen, Peter, Torbati, Sam S., Matusov, Yuri, Choe, June, Hindoyan, Niree A., Jackman, Susan E., Bayoumi, Emad, Wynter, Timothy, Caudill, Antonina, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Mehdikhani, Shaunt, O'Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Miller, Chadwick, Gibbs, Keven W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sara N., Mayer, Kirby P., Bissel, Brittany, Bledsoe, Joseph, Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Armbruster, Brent P., Montgomery, Quinn, Applegate, Darrin, Kumar, Naresh, Fergus, Melissa, Serezlic, Erna, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Aston, Valerie T., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Sánchez, Adriana, Popielski, Laura, Rivasplata, Heather, Turner, Melissa, Vjecha, Michael, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Lucas, Claudia Sanchez, DellaValle, Natalie, Gonzales, Sonia, Scott, James, Wyles, David, Douglas, Ivor, Haukoos, Jason, Kamis, Kevin, Robinson, Caitlin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Markowitz, Norman, Pastor, Erika, Ramesh, Mayur, Brar, Indira, Rivers, Emanuel, Kumar, Princy, Menna, Maximiliano, Biswas, Kousick, Harrington, Cristin, Delp, Alex, Pandit, Lavannya, Hines-Munson, Casey, Van, John, Dillon, Laura, Want, Yiqun, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Roller, Brentin, Nguyen, Chinh, Mikail, Amani, Raben, Dorthe, Jensen, Tomas O., Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esmann, Frederik V.L., Clausen, Clara Lundetoft, Hovmand, Nichlas, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Høgsberg, Dorthe S., Rastoder, Ema, Kamstrup, Thobias, Bergsøe, Christina Marisa, Østergaard, Lars, Stærke, Nina Breinholt, Johansen, Isik S., Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Helleberg, Marie, Gerstoft, Jan, Jensen, Tomas Østergaard, Lindegaard, Birgitte, Pedersen, Thomas Ingemann, Røge, Birgit Thorup, Løfberg, Sandra Valborg, Hansen, Thomas Michael, Nielsen, Ariella Denize, von Huth, Sebastian Leicht, Nielsen, Henrik, Thisted, Rikke Krog, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Lindnér, Cecilia Ebba Clara Ellinor, Wiese, Lothar, Knudsen, Lene Surland, Nytofte, Nikolaj Julian Skrøder, Havmøller, Signe Ravn, Paredes, Roger, Exposito, Maria, Fernández-Cruz, Eduardo, Muñoz, José, Arribas, Jose R., Estrada, Vicente, Horcajada, Juan P., Burgos, Joaquin, Morales-Rull, Jose Luis, Braun, Dominique L., West, Emily, M'Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, Horban, Andrzej, Bednarska, Agnieszka, Jurek, Natalia, Fätkenheuer, Gerd, Malinm, Jakob J., Matthews, Gail, Kelleher, Anthony, Cabrera, Gesalit, Carey, Catherine, Hough, Sally, Virachit, Sophie, Zhong, Amy, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David, Ong, Sean, Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Hudson, Fleur, Parmar, Mahesh KB, Goodman, Anna, Badrock, Jonathan, Gregory, Adam, Harris, Nicola, Touloumi, Giota, Pantaz, Nikos, Gioukari, Vicky, Lutaakome, Joseph, Kityo, Cissy M., Mugerwa, Henry, Kiweewa, Francis, Osinusi, Anu, Tipple, Craig, Willis, Angela, Peppercorn, Amanda, Watson, Helen, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Adams, Amy, Albert, Sara, Balde, Abby, Baracz, Michelle, Baseler, Beth, Becker, Nancy, Bielica, Mona, Billouin-Frazier, Shere, Cash, Jennifer, Choudhary, Jay, Dolney, Suzanne, Dixon, Mary, Eyler, Carolyn, Frye, Leanna, Galcik, Michael, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hissey, Debbie, Hogarty, Debi, Hohn, Matt, Holley, H Preston, Hoopengardner, Lisa, Huber, Lynda, Jankelevich, Shirley, Krauss, Gary, Lake, Eileen, Linton, Jessica, MacDonald, Leah, Manandhar, Meryan, Spinelli-Nadzam, Mary, Oluremi, Charles, Proffitt, Calvin, Rudzinski, Erin, Sandrus, Jen, Schaffhauser, Marylu, Schechner, Adam, Suders, Connie, Gerry, Norman P., Smith, Kenneth, Solomon, Courtney, Kubernac, Amanda, Rashid, Marium, Patel, Bhakti, Kubernac, Robert, Murphy, Joseph, Hoover, Marie L., Brown, Craig, DuChateau, Nadine, Flosi, Adam, Johnson, Les, Treagus, Amy, and Wenner, Christine

Published
2022
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11. Effectiveness of Smallpox Vaccination to Prevent Mpox in Military Personnel

Author

Titanji, Boghuma K., primary, Eick-Cost, Angelia, additional, Partan, Elizabeth S., additional, Epstein, Lauren, additional, Wells, Natalie, additional, Stahlman, Shauna L., additional, Devineni, Poornima, additional, Munyoki, Brigid, additional, Pyarajan, Saiju, additional, Balajee, Abirami, additional, Smith, Jeremy, additional, Woods, Chris W., additional, Holodniy, Mark, additional, Davey, Victoria J., additional, Bonomo, Robert A., additional, Young-Xu, Yinong, additional, and Marconi, Vincent C., additional

Published
2023
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12. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Brown, Samuel M, primary, Barkauskas, Christina E, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Phillips, Andrew N, additional, Leither, Lindsay, additional, Peltan, Ithan D, additional, Lanspa, Michael, additional, Gilstrap, Daniel L, additional, Mourad, Ahmad, additional, Lane, Kathleen, additional, Beitler, Jeremy R, additional, Serra, Alexis L, additional, Garcia, Ivan, additional, Almasri, Eyad, additional, Fayed, Mohamed, additional, Hubel, Kinsley, additional, Harris, Estelle S, additional, Middleton, Elizabeth A, additional, Barrios, Macy A G, additional, Mathews, Kusum S, additional, Goel, Neha N, additional, Acquah, Samuel, additional, Mosier, Jarrod, additional, Hypes, Cameron, additional, Salvagio Campbell, Elizabeth, additional, Khan, Akram, additional, Hough, Catherine L, additional, Wilson, Jennifer G, additional, Levitt, Joseph E, additional, Duggal, Abhijit, additional, Dugar, Siddharth, additional, Goodwin, Andrew J, additional, Terry, Charles, additional, Chen, Peter, additional, Torbati, Sam, additional, Iyer, Nithya, additional, Sandkovsky, Uriel S, additional, Johnson, Nicholas J, additional, Robinson, Bryce R H, additional, Matthay, Michael A, additional, Aggarwal, Neil R, additional, Douglas, Ivor S, additional, Casey, Jonathan D, additional, Hache-Marliere, Manuel, additional, Georges Youssef, J, additional, Nkemdirim, William, additional, Leshnower, Brad, additional, Awan, Omar, additional, Pannu, Sonal, additional, O'Mahony, Darragh Shane, additional, Manian, Prasad, additional, Awori Hayanga, J W, additional, Wortmann, Glenn W, additional, Tomazini, Bruno M, additional, Miller, Robert F, additional, Jensen, Jens-Ulrik, additional, Murray, Daniel D, additional, Bickell, Nina A, additional, Zatakia, Jigna, additional, Burris, Sarah, additional, Higgs, Elizabeth S, additional, Natarajan, Ven, additional, Dewar, Robin L, additional, Schechner, Adam, additional, Kang, Nayon, additional, Arenas-Pinto, Alejandro, additional, Hudson, Fleur, additional, Ginde, Adit A, additional, Self, Wesley H, additional, Rogers, Angela J, additional, Oldmixon, Cathryn F, additional, Morin, Haley, additional, Sanchez, Adriana, additional, Weintrob, Amy C, additional, Cavalcanti, Alexandre Biasi, additional, Davis-Karim, Anne, additional, Engen, Nicole, additional, Denning, Eileen, additional, Taylor Thompson, B, additional, Gelijns, Annetine C, additional, Kan, Virginia, additional, Davey, Victoria J, additional, Lundgren, Jens D, additional, Babiker, Abdel G, additional, Neaton, James D, additional, Lane, H Clifford, additional, Tierney, John, additional, Vogel, Susan E., additional, McNay, Laura A., additional, Cahill, Kelly, additional, Crew, Page, additional, Sardana, Ratna, additional, Segal Raim, Sharo, additional, Shaw-Saliba, Katy, additional, Atri, Negin, additional, Miller, Mark, additional, Vallee, David, additional, Chung, Lucy, additional, Delph, Yvette, additional, Adam, Stacey J., additional, Read, Sarah, additional, Draghia-Akli, Ruxandra, additional, Harrigan, Rachel, additional, Carlsen, Amy, additional, Carter, Anita, additional, DuChene, Alain, additional, Eckroth, Kate, additional, Frase, Alex, additional, Harrison, Merrie, additional, Meger, Sue, additional, Quan, Kien, additional, Quan, Siu Fun, additional, Reilly, Cavan, additional, Thompson, Greg, additional, Walski, Jamie, additional, Moskowitz, Alan J., additional, Bagiella, Emilia, additional, Moquete, Ellen, additional, O'Sullivan, Karen, additional, Marks, Mary E., additional, Accardi, Evan, additional, Kinzel, Emily, additional, Bedoya, Gabriela, additional, Gupta, Lopa, additional, Overbey, Jessica R., additional, Padillia, Maria L., additional, Santos, Milerva, additional, Gillinov, Marc A., additional, Miller, Marissa A., additional, Taddei-Peters, Wendy C., additional, Fenton, Kathleen, additional, Smith, Peter K., additional, Vekstein, Andrew M., additional, Ko, Emily R., additional, Al-Hegelan, Mashael S., additional, McGowan, Lauren M., additional, Motta, Mary, additional, Howell, Shauna, additional, Bent, Francine, additional, Kalager, Rachel, additional, Chan, Emmanuel, additional, Aloor, Heather L., additional, Griffin, S. Michelle, additional, Covington, Anna, additional, McLendon-Arvik, Beth, additional, Bussadori, Barbara, additional, Miller-Bell, Mary, additional, Sampey, Cathy, additional, Gaver, Vincent, additional, Hollister, Beth A., additional, Giangiacomo, Dana M., additional, Pauley, Alena, additional, Patel, Aashay, additional, Classon, Chris, additional, Frazier, Madison, additional, Osborne, Robyn, additional, Conlon, Debbi H., additional, Joshi, Marybeth, additional, Gottlieb, Robert L., additional, Mack, Michael, additional, Berhe, Mezgebe, additional, Haley, Clinton, additional, Dishner, Emma, additional, Bettacchi, Christopher, additional, Golden, Kevin, additional, Duhaime, Erin, additional, Ryan, Madison, additional, Tallmadge, Catherine, additional, Estrada, Lorie, additional, Jones, Felecia, additional, Villa, Samantha, additional, Wang, Samantha, additional, Robert, Raven, additional, Coleman, Tanquinisha, additional, Clariday, Laura, additional, Baker, Rebecca, additional, Hurutado-Rodriguez, Mariana, additional, Iram, Nazia, additional, Fresnedo, Michelle, additional, Davis, Allyson, additional, Leonard, Kiara, additional, Ramierez, Noelia, additional, Thammavong, Jon, additional, Duque, Krizia, additional, Turner, Emma, additional, Fisher, Tammy, additional, Robinson, Dianna, additional, Ransom, Desirae, additional, Maldonado, Nicholas, additional, Lusk, Erica, additional, Killian, Aaron, additional, Palacios, Adriana, additional, Solis, Edilia, additional, Jerrow, Janet, additional, Watts, Matthew, additional, Whitacre, Heather, additional, Cothran, Elizabeth, additional, Bender, William, additional, Miller, Jeffrey, additional, Nugent, Katherine, additional, Farrington, Woodrow, additional, Baio, Kim T., additional, McBride, Mary K., additional, Fielding, Michele, additional, Mathewson, Sonya, additional, Porte, Kristina, additional, Haley, Elizabeth, additional, Rogers, Susan, additional, Tyler, Derrick, additional, Perin, Emerson, additional, Costello, Briana, additional, Postalian, Alexander, additional, Sohail, Rizwan, additional, Hinsu, Punit, additional, Watson, Carolyn, additional, Kappenman, Casey, additional, Chen, James, additional, Walker, Kim, additional, Fink, Melyssa, additional, Phillip, Gabrielle, additional, Mahon, Kim, additional, Sturgis, Lydia, additional, Maher, Patrick, additional, Rogers, Linda, additional, Ng, Nicole, additional, Marshall, Jason, additional, Bassily-Marcus, Adel, additional, Cohen, Ivy, additional, Ramoo, Shamini, additional, Malhotra, Aryan, additional, Kessler, Jonathan, additional, Goetz, Rebekah, additional, Badhwar, Vinay, additional, Hayanga, Jeremiah, additional, Giblin Sutton, Lisa, additional, Williams, Roger, additional, Berry Bartolo, Elizabeth, additional, Walker, Dmitry, additional, Bunner, Robin, additional, Glaze, Chad, additional, Aucremanne, Tanja, additional, Bishop, James, additional, Kelley, Macey, additional, Peterson, Autumn, additional, Sauerborn, Erica, additional, Reckart, Robin, additional, Miller, Brittany, additional, Mittel, Aaron, additional, Darmanian, Anita, additional, Rosen, Amanda, additional, Madahar, Purnema, additional, Schicchi, John, additional, Gosek, Katarzyna, additional, Dzierba, Amy, additional, Wahab, Romina, additional, Eng, Connie, additional, Al-Saadi, Mukhtar, additional, Zahiruddin, Faisal, additional, Syed, Mohi, additional, George, Michael, additional, Patel, Varsha, additional, Onwunyi, Chisom, additional, Barroso da Costa, Rosa, additional, North, Crystal, additional, Ringwood, Nancy, additional, Fitzgerald, Laura, additional, Muzikansky, Ariela, additional, Morse, Richard, additional, Brower, Roy G., additional, Reineck, Lora A., additional, Bienstock, Karen, additional, Hou, Peter, additional, Steingrub, Jay S., additional, Tidswell, Mark A., additional, Kozikowski, Lori-Ann, additional, Kardos, Cynthia, additional, De Souza, Leslie, additional, Talmor, Daniel, additional, Shapiro, Nathan, additional, Hibbert, Kathryn, additional, Brait, Kelsey, additional, Kone, Mamary, additional, Hendey, Gregory, additional, Kangelaris, Kirsten N., additional, Ashktorab, Kimia, additional, Gropper, Rachel, additional, Agrawal, Anika, additional, Timothy, Kelly, additional, Zhou, Hanjing, additional, Hughes, Alyssa, additional, Garcia, Rebekah, additional, Torres, Adrian, additional, Hernandez-Almaraz, Maria Elena, additional, Vojnik, Rosemary, additional, Perez, Cynthia, additional, McDowell, Jordan, additional, Chang, Steven Y., additional, Vargas, Julia, additional, Moss, Marc, additional, McKeehan, Jeffrey, additional, Higgins, Carrie, additional, Johnson, Emily, additional, Slaughter, Suzanne, additional, Wyles, David, additional, Hiller, Terra, additional, Oakes, Judy, additional, Garcia, Ana, additional, Gravitz, Stephanie, additional, Lyle, Carolynn, additional, Swanson, Diandra, additional, Gong, Michelle Ng., additional, Richardson, Lynnne D., additional, Chen, Jen-Ting, additional, Moskowitz, Ari, additional, Mohamed, Amira, additional, Lopez, Brenda, additional, Amosu, Omowunmi, additional, Tzehaie, Hiwet, additional, Boujid, Sabah, additional, Bixby, Billie, additional, Lopez, Anitza A., additional, Durley, JaVon, additional, Gilson, Boris, additional, Hite, R. Duncan, additional, Wang, Henry, additional, Wiedemann, Hebert P., additional, Mehkri, Omar, additional, Ashok, Kiran, additional, King, Alexander, additional, Brennan, Connery, additional, Exline, Matthew C., additional, Englert, Joshua A., additional, Karow, Sarah, additional, Schwartz, Elizabeth, additional, So, Preston, additional, So, Madison, additional, Krol, Olivia F., additional, Briceno Parra, Genesis I., additional, Mills, Emmanuel Nii Lantei, additional, Oh, Minn, additional, Pena, Jose, additional, Martínez, Jesús Alejandro, additional, Jackman, Susan E., additional, Bayoumi, Emad, additional, Pascual, Ethan, additional, Caudill, Antonina, additional, Chen, Po-En, additional, Richardson, Tabia, additional, Clapham, Gregg J., additional, Herrera, Lisa, additional, Ojukwu, Cristabelle, additional, Fine, Devin, additional, Gomez, Millie J., additional, Choi-Kuaea, Yunhee, additional, Weissberg, Gwendolyn, additional, Isip, Katherine, additional, Mattison, Brittany, additional, Tran, Dana, additional, Emilov Dukov, Jennifer, additional, Chung, Paul, additional, Kang, Bo Ran, additional, Escobar, Lauren, additional, Tran, Trung, additional, Baig, Saba, additional, Wallick, Julie A., additional, Duven, Alexandria M., additional, Fletcher, Dakota D., additional, Gundel, Stephanie, additional, Fuentes, Megan, additional, Newton, Maranda, additional, Peterson, Emily, additional, Jiang, Kelsey, additional, Files, D. Clark, additional, Miller, Chadwick, additional, Lematty, Caitlin, additional, Rasberry, April, additional, Warden, Ashley, additional, Bledsoe, Joseph, additional, Knowlton, Kirk, additional, Knox, Daniel B., additional, Klippel, Carolyn, additional, Armbruster, Brent P., additional, Applegate, Darrin, additional, Imel, Karah, additional, Fergus, Melissa, additional, Rahmati, Kasra, additional, Jensen, Hannah, additional, Aston, Valerie T., additional, Jeppson, Joshua, additional, Marshall, J. Hunter, additional, Lumpkin, Jenna, additional, Smith, Cassie, additional, Burke, Tyler, additional, Gray, Andrew, additional, Paine, Robert, additional, Callahan, Sean, additional, Yamane, Misty, additional, Waddoups, Lindsey, additional, Rice, Todd W., additional, Johnson, Jakea, additional, Gray, Christopher, additional, Hays, Margaret, additional, Roth, Megan, additional, Musick, Sarah, additional, Miller, Karen, additional, Semler, Matthew W., additional, Popielski, Laura, additional, Kambo, Amy, additional, Viens, Kimberly, additional, Turner, Melissa, additional, Vjecha, Michael J., additional, Denyer, Rachel, additional, Khosla, Rahul, additional, Rajendran, Bindu, additional, Gonzales, Melissa, additional, Moriarty, Theresa, additional, Biswas, Kousick, additional, Harrington, Cristin, additional, Garcia, Amanda, additional, Bremer, Tammy, additional, Burke, Tara, additional, Koker, Brittany, additional, Pittman, David, additional, Vasudeva, Shikha S., additional, Anholm, James D., additional, Specht, Lennard, additional, Rodriguez, Aimee, additional, Ngo, Han, additional, Duong, Lien, additional, Previte, Matthew, additional, Raben, Dorthe, additional, Nielsen, Charlotte B., additional, Friis Larsen, Jakob, additional, Peters, Lars, additional, Matthews, Gail, additional, Kelleher, Anthony, additional, Polizzotto, Mark, additional, Carey, Catherine, additional, Chang, Christina, additional, Dharan, Nila, additional, Hough, Sally, additional, Virachit, Sophie, additional, Davidson, Sarah, additional, Bice, Daniel J., additional, Ognenovska, Katherine, additional, Cabrera, Gesalit, additional, Flynn, Ruth, additional, Abdelghany, Mazin, additional, Baseler, Beth, additional, Teitelbaum, Marc, additional, Holley, H. Preston, additional, Jankelevich, Shirley, additional, Adams, Amy, additional, Becker, Nancy, additional, Doleny, Suzanne, additional, Hissey, Debbie, additional, Simpson, Shelly, additional, Kim, Mi Ha, additional, Beeler, Joy, additional, Harmon, Liam, additional, Vanderpuye, Sharon, additional, Yeon, Lindsey, additional, Frye, Leanna, additional, Rudzinski, Erin, additional, Buehn, Molly, additional, Eccard-Koons, Vanessa, additional, Frary, Sadie, additional, MacDonalad, Leah, additional, Cash, Jennifer, additional, Hoopengardner, Lisa, additional, Linton, Jessica, additional, Nelson, Michaela, additional, Spinelli-Nadzam, Mary, additional, Proffitt, Calvin, additional, Lee, Christopher, additional, Engel, Theresa, additional, Fontaine, Laura, additional, Osborne, CK, additional, Hohn, Matt, additional, Galcik, Michael, additional, Thompson, DeeDee, additional, Sandrus, Jen, additional, Manchard, Jon, additional, Giri, Jiwan, additional, Kopka, Stacy, additional, Chang, Weizhong, additional, Sherman, Brad T., additional, Rupert, Adam W., additional, Highbarger, Helene, additional, Baseler, Michael, additional, Lallemand, Perrine, additional, Rehman, Tauseef, additional, Imamichi, Tom, additional, Laverdure, Sylvain, additional, Paudel, Sharada, additional, Cook, Kyndal, additional, Haupt, Kendra, additional, Hazen, Allison, additional, Badralmaa, Yunden, additional, Highbarger, Jeroen, additional, McCormack, Ashley, additional, Gerry, Norman P., additional, Smith, Kenneth, additional, Patel, Bhakti, additional, Domeraski, Nadia, additional, Hoover, Marie L., additional, DuChateau, Nadine, additional, Flosi, Adam, additional, Nelson, Rich, additional, Stojanovic, Jelena, additional, and Wenner, Christine, additional

Published
2023
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17. The Association of Baseline Plasma SARS-CoV-2 Nucleocapsid Antigen Level and Outcomes in Patients Hospitalized With COVID-19

Author

ACTIV-3/TICO Study Group, Rogers, Angela J, Wentworth, Deborah, Phillips, Andrew, Shaw-Saliba, Katy, Dewar, Robin L, Aggarwal, Neil R, Babiker, Abdel G, Chang, Weizhong, Dharan, Nila J, Davey, Victoria J, Higgs, Elizabeth S, Gerry, Norman, Ginde, Adit A, Hayanga, JW Awori, Highbarger, Helene, Highbarger, Jeroen L, Jain, Mamta K, Kan, Virginia, Kim, Kami, Lallemand, Perrine, Leshnower, Bradley G, Lutaakome, Joseph K, Matthews, Gail, Mourad, Ahmad, Mylonakis, Eleftherios, Natarajan, Ven, Padilla, Maria L, Pandit, Lavannya M, Paredes, Roger, Pett, Sarah, Ramachandruni, Srikanth, Rehman, M Tauseef, Sherman, Brad T, Files, D Clark, Brown, Samuel M, Matthay, Michael A, Thompson, B Taylor, Neaton, James D, Lane, H Clifford, and Lundgren, Jens D

Subjects
Adult, Male, SARS-CoV-2, Prevention, Inflammatory and immune system, COVID-19, Medical and Health Sciences, Vaccine Related, Cross-Sectional Studies, Emerging Infectious Diseases, Infectious Diseases, Good Health and Well Being, Clinical Research, Biodefense, General & Internal Medicine, Humans, ACTIV-3/TICO Study Group, Nucleocapsid, Infection, Lung
Abstract

BackgroundLevels of plasma SARS-CoV-2 nucleocapsid (N) antigen may be an important biomarker in patients with COVID-19 and enhance our understanding of the pathogenesis of COVID-19.ObjectiveTo evaluate whether levels of plasma antigen can predict short-term clinical outcomes and identify clinical and viral factors associated with plasma antigen levels in hospitalized patients with SARS-CoV-2.DesignCross-sectional study of baseline plasma antigen level from 2540 participants enrolled in the TICO (Therapeutics for Inpatients With COVID-19) platform trial from August 2020 to November 2021, with additional data on day 5 outcome and time to discharge.Setting114 centers in 10 countries.ParticipantsAdults hospitalized for acute SARS-CoV-2 infection with 12 days or less of symptoms.MeasurementsBaseline plasma viral N antigen level was measured at a central laboratory. Delta variant status was determined from baseline nasal swabs using reverse transcriptase polymerase chain reaction. Associations between baseline patient characteristics and viral factors and baseline plasma antigen levels were assessed using both unadjusted and multivariable modeling. Association between elevated baseline antigen level of 1000 ng/L or greater and outcomes, including worsening of ordinal pulmonary scale at day 5 and time to hospital discharge, were evaluated using logistic regression and Fine-Gray regression models, respectively.ResultsPlasma antigen was below the level of quantification in 5% of participants at enrollment, and 1000 ng/L or greater in 57%. Baseline pulmonary severity of illness was strongly associated with plasma antigen level, with mean plasma antigen level 3.10-fold higher among those requiring noninvasive ventilation or high-flow nasal cannula compared with room air (95% CI, 2.22 to 4.34). Plasma antigen level was higher in those who lacked antispike antibodies (6.42 fold; CI, 5.37 to 7.66) and in those with the Delta variant (1.73 fold; CI, 1.41 to 2.13). Additional factors associated with higher baseline antigen level included male sex, shorter time since hospital admission, decreased days of remdesivir, and renal impairment. In contrast, race, ethnicity, body mass index, and immunocompromising conditions were not associated with plasma antigen levels. Plasma antigen level of 1000 ng/L or greater was associated with a markedly higher odds of worsened pulmonary status at day 5 (odds ratio, 5.06 [CI, 3.41 to 7.50]) and longer time to hospital discharge (median, 7 vs. 4 days; subhazard ratio, 0.51 [CI, 0.45 to 0.57]), with subhazard ratios similar across all levels of baseline pulmonary severity.LimitationsPlasma samples were drawn at enrollment, not hospital presentation. No point-of-care test to measure plasma antigen is currently available.ConclusionElevated plasma antigen is highly associated with both severity of pulmonary illness and clinically important patient outcomes. Multiple clinical and viral factors are associated with plasma antigen level at presentation. These data support a potential role of ongoing viral replication in the pathogenesis of SARS-CoV-2 in hospitalized patients.Primary funding sourceU.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.

Published
2022

18. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial

Author

ACTIV-3/TICO Study Group, Barkauskas, Christina, Mylonakis, Eleftherios, Poulakou, Garyfallia, Young, Barnaby E, Vock, David M, Siegel, Lianne, Engen, Nicole, Grandits, Greg, Mosaly, Nilima R, Vekstein, Andrew M, Rogers, Ralph, Shehadeh, Fadi, Kaczynski, Matthew, Mylona, Evangelia K, Syrigos, Konstantinos N, Rapti, Vasiliki, Lye, David C, Hui, Diong Shiau, Leither, Lindsay, Knowlton, Kirk U, Jain, Mamta K, Marines-Price, Rubria, Osuji, Alice, Overcash, J Scott, Kalomenidis, Ioannis, Barmparessou, Zafeiria, Waters, Michael, Zepeda, Karla, Chen, Peter, Torbati, Sam, Kiweewa, Francis, Sebudde, Nicholus, Almasri, Eyad, Hughes, Alyssa, Bhagani, Sanjay R, Rodger, Alison, Sandkovsky, Uriel, Gottlieb, Robert L, Nnakelu, Eriobu, Trautner, Barbara, Menon, Vidya, Lutaakome, Joseph, Matthay, Michael, Robinson, Philip, Protopapas, Konstantinos, Koulouris, Nikolaos, Kimuli, Ivan, Baduashvili, Amiran, Braun, Dominique L, Günthard, Huldrych F, Ramachandruni, Srikanth, Kidega, Robert, Kim, Kami, Hatlen, Timothy J, Phillips, Andrew N, Murray, Daniel D, Jensen, Tomas O, Padilla, Maria L, Accardi, Evan X, Shaw-Saliba, Katy, Dewar, Robin L, Teitelbaum, Marc, Natarajan, Ven, Laverdure, Sylvain, Highbarger, Helene C, Rehman, M Tauseef, Vogel, Susan, Vallée, David, Crew, Page, Atri, Negin, Schechner, Adam J, Pett, Sarah, Hudson, Fleur, Badrock, Jonathan, Touloumi, Giota, Brown, Samuel M, Self, Wesley H, North, Crystal M, Ginde, Adit A, Chang, Christina C, Kelleher, Anthony, Nagy-Agren, Stephanie, Vasudeva, Shikha, Looney, David, Nguyen, Hien H, Sánchez, Adriana, Weintrob, Amy C, Grund, Birgit, Sharma, Shweta, Reilly, Cavan S, Paredes, Roger, Bednarska, Agnieszka, Gerry, Norman P, Babiker, Abdel G, Davey, Victoria J, Gelijns, Annetine C, Higgs, Elizabeth S, Kan, Virginia, and Matthews, Gail

Subjects
Adult, SARS-CoV-2, Recombinant Fusion Proteins, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, Medical and Health Sciences, COVID-19 Drug Treatment, Treatment Outcome, Good Health and Well Being, Double-Blind Method, Clinical Research, 6.1 Pharmaceuticals, General & Internal Medicine, Humans, Designed Ankyrin Repeat Proteins, ACTIV-3/TICO Study Group, Lung
Abstract

BackgroundEnsovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.ObjectiveTo investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.DesignDouble-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).SettingMultinational, multicenter trial.ParticipantsAdults hospitalized with COVID-19.InterventionIntravenous ensovibep, 600 mg, or placebo.MeasurementsEnsovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90.ResultsAn independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n=247) or placebo (n=238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P=0.68; OR>1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR>1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR&nbsp

Published
2022

19. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Author

Holland, Thomas L., primary, Ginde, Adit A., additional, Paredes, Roger, additional, Murray, Thomas A., additional, Engen, Nicole, additional, Grandits, Greg, additional, Vekstein, Andrew, additional, Ivey, Noel, additional, Mourad, Ahmad, additional, Sandkovsky, Uriel, additional, Gottlieb, Robert L., additional, Berhe, Mezgebe, additional, Jain, Mamta K., additional, Marines-Price, Rubria, additional, Agbor Agbor, Barbine Tchamba, additional, Mateu, Lourdes, additional, España-Cueto, Sergio, additional, Lladós, Gemma, additional, Mylonakis, Eleftherios, additional, Rogers, Ralph, additional, Shehadeh, Fadi, additional, Filbin, Michael R., additional, Hibbert, Kathryn A., additional, Kim, Kami, additional, Tran, Thanh, additional, Morris, Peter E., additional, Cassity, Evan P., additional, Trautner, Barbara, additional, Pandit, Lavannya M., additional, Knowlton, Kirk U., additional, Leither, Lindsay, additional, Matthay, Michael A., additional, Rogers, Angela J., additional, Drake, Wonder, additional, Jones, Beatrice, additional, Poulakou, Garyfallia, additional, Syrigos, Konstantinos N., additional, Fernández-Cruz, Eduardo, additional, Di Natale, Marisa, additional, Almasri, Eyad, additional, Balerdi-Sarasola, Leire, additional, Bhagani, Sanjay R., additional, Boyle, Katherine L., additional, Casey, Jonathan D., additional, Chen, Peter, additional, Douin, David J., additional, Files, D. Clark, additional, Günthard, Huldrych F., additional, Hite, R. Duncan, additional, Hyzy, Robert C., additional, Khan, Akram, additional, Kibirige, Moses, additional, Kidega, Robert, additional, Kimuli, Ivan, additional, Kiweewa, Francis, additional, Jensen, Jens-Ulrik, additional, Leshnower, Bradley G., additional, Lutaakome, Joseph K., additional, Manian, Prasad, additional, Menon, Vidya, additional, Morales-Rull, Jose Luis, additional, O'Mahony, D. Shane, additional, Overcash, J. Scott, additional, Ramachandruni, Srikant, additional, Steingrub, Jay S., additional, Taha, Hassan S., additional, Waters, Michael, additional, Young, Barnaby E., additional, Phillips, Andrew N., additional, Murray, Daniel D., additional, Jensen, Tomas O., additional, Padilla, Maria L., additional, Sahner, David, additional, Shaw-Saliba, Katy, additional, Dewar, Robin L., additional, Teitelbaum, Marc, additional, Natarajan, Ven, additional, Rehman, M. Tauseef, additional, Pett, Sarah, additional, Hudson, Fleur, additional, Touloumi, Giota, additional, Brown, Samuel M., additional, Self, Wesley H., additional, Chang, Christina C., additional, Sánchez, Adriana, additional, Weintrob, Amy C., additional, Hatlen, Timothy, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Reilly, Cavan S., additional, Garbes, Pedro, additional, Esser, Mark T., additional, Templeton, Alison, additional, Babiker, Abdel G., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Higgs, Elizabeth S., additional, Kan, Virginia, additional, Matthews, Gail, additional, Thompson, B. Taylor, additional, Neaton, James D., additional, Lane, H. Clifford, additional, and Lundgren, Jens D., additional

Published
2022
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20. Lessons from an international trial evaluating vaccination strategies for recovered inpatients with COVID-19 (VATICO)

Author

Mylonakis, Eleftherios, primary, Lutaakome, Joseph, additional, Jain, Mamta K., additional, Rogers, Angela J., additional, Moltó, José, additional, Benet, Susana, additional, Mourad, Ahmad, additional, Files, D. Clark, additional, Mugerwa, Henry, additional, Kityo, Cissy, additional, Kiweewa, Francis, additional, Nalubega, Mary Grace, additional, Kitonsa, Jonathan, additional, Nabenkema, Evelyn, additional, Murray, Daniel D., additional, Braun, Dominique, additional, Kamel, Dena, additional, Higgs, Elizabeth S., additional, Hatlen, Timothy J., additional, Kan, Virginia L., additional, Sanchez, Adriana, additional, Tierney, John, additional, Denner, Eileen, additional, Wentworth, Deborah, additional, Babiker, Abdel G., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Matthews, Gail V., additional, Thompson, B. Taylor, additional, Lane, H. Clifford, additional, Neaton, James D., additional, and Lundgren, Jens D., additional

Published
2022
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26. Lessons from an international trial evaluating vaccination strategies for recovered inpatients with COVID-19 (VATICO)

Author

Mylonakis, Eleftherios, Lutaakome, Joseph, Jain, Mamta K., Rogers, Angela J., Molto, Jose, Benet, Susana, Mourad, Ahmad, Files, D. Clark, Mugerwa, Henry, Kityo, Cissy, Kiweewa, Francis, Nalubega, Mary Grace, Kitonsa, Jonathan, Nabenkema, Evelyn, Murray, Daniel D., Braun, Dominique, Kamel, Dena, Higgs, Elizabeth S., Hatlen, Timothy J., Kan, Virginia L., Sanchez, Adriana, Tierney, John, Denner, Eileen, Wentworth, Deborah, Babiker, Abdel G., Davey, Victoria J., Gelijns, Annetine C., Matthews, Gail, Thompson, B. Taylor, Lane, H. Clifford, Neaton, James D., Lundgren, Jens D., Mylonakis, Eleftherios, Lutaakome, Joseph, Jain, Mamta K., Rogers, Angela J., Molto, Jose, Benet, Susana, Mourad, Ahmad, Files, D. Clark, Mugerwa, Henry, Kityo, Cissy, Kiweewa, Francis, Nalubega, Mary Grace, Kitonsa, Jonathan, Nabenkema, Evelyn, Murray, Daniel D., Braun, Dominique, Kamel, Dena, Higgs, Elizabeth S., Hatlen, Timothy J., Kan, Virginia L., Sanchez, Adriana, Tierney, John, Denner, Eileen, Wentworth, Deborah, Babiker, Abdel G., Davey, Victoria J., Gelijns, Annetine C., Matthews, Gail, Thompson, B. Taylor, Lane, H. Clifford, Neaton, James D., and Lundgren, Jens D.

Abstract

The protection provided by natural versus hybrid immunity from COVID-19 is unclear. We reflect on the challenges from trying to conduct a randomized post-SARS-CoV-2 infection vaccination trial study with rapidly evolving scientific data, vaccination guidelines, varying international policies, difficulties with vaccine availability, vaccine hesitancy, and a constantly evolving virus.

Published
2022

27. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents:Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D., Babiker, Abdel G., Baker, Jason V., Barkauskas, Christina E., Brown, Samuel M., Chang, Christina C., Davey, Victoria J., Gelijns, Annetine C., Ginde, Adit A., Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L., Lane, H. Clifford, Murray, Thomas A., Paredes, Roger, Parmar, Mahesh K.B., Pett, Sarah, Phillips, Andrew N., Polizzotto, Mark N., Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B. Taylor, Young, Barnaby E., Neaton, James D., Lundgren, Jens D., Murray, Daniel D., Babiker, Abdel G., Baker, Jason V., Barkauskas, Christina E., Brown, Samuel M., Chang, Christina C., Davey, Victoria J., Gelijns, Annetine C., Ginde, Adit A., Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L., Lane, H. Clifford, Murray, Thomas A., Paredes, Roger, Parmar, Mahesh K.B., Pett, Sarah, Phillips, Andrew N., Polizzotto, Mark N., Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B. Taylor, Young, Barnaby E., Neaton, James D., and Lundgren, Jens D.

Abstract

Background/aims: Safe and effective therapies for COVID-19 are urgently needed. In order to meet this need, the Accelerating COVID-19 Therapeutic Interventions and Vaccines public–private partnership initiated the Therapeutics for Inpatients with COVID-19. Therapeutics for Inpatients with COVID-19 is a multi-arm, multi-stage platform master protocol, which facilitates the rapid evaluation of the safety and efficacy of novel candidate antiviral therapeutic agents for adults hospitalized with COVID-19. Five agents have so far entered the protocol, with rapid answers already provided for three of these. Other agents are expected to enter the protocol throughout 2021. This protocol contains a number of key design and implementation features that, along with challenges faced by the protocol team, are presented and discussed. Methods: Three clinical trial networks, encompassing a global network of clinical sites, participated in the protocol development and implementation. Therapeutics for Inpatients with COVID-19 utilizes a multi-arm, multi-stage design with an agile and robust approach to futility and safety evaluation at 300 patients enrolled, with subsequent expansion to full sample size and an expanded target population if the agent shows an acceptable safety profile and evidence of efficacy. Rapid recruitment to multiple agents is enabled through the sharing of placebo, the confining of agent-specific information to protocol appendices, and modular consent forms. In collaboration with the Food and Drug Administration, a thorough safety data collection and Data and Safety Monitoring Board schedule was developed for the study of potential therapeutic agents with limited in-human data in hospitalized patients with COVID-19. Results: As of 8 August 2021, five agents have entered the Therapeutics for Inpatients with COVID-19 master protocol and a total of 1909 participants have been randomized to one of these agents or matching placebo. There were a number of challeng

Published
2022

30. Tixagevimab/Cilgavimab for Treatment of Hospitalised COVID-19 Patients: A Randomised, Double-Blind, Phase 3 Trial

Author

Holland, Thomas L., primary, Ginde, Adit A., additional, Paredes, Roger, additional, Murray, Thomas A., additional, Engen, Nicole, additional, Grandits, Greg, additional, Vekstein, Andrew, additional, Ivey, Noel, additional, Mourad, Ahmad, additional, Sandkovsky, Uriel, additional, Gottlieb, Robert L., additional, Berhe, Mezgebe, additional, Jain, Mamta, additional, Marines-Price, Rubria, additional, Tchamba Agbor Agbor, Barbine, additional, Mateu, Lourdes, additional, Espana-Cueto, Sergio, additional, Llados, Gemma, additional, Mylonakis, Eleftherios, additional, Rogers, Ralph, additional, Shehadeh, Fadi, additional, Filbin, Michael R., additional, Hibbert, Kathryn A., additional, Kim, Kami, additional, Tran, Thanh, additional, Morris, Peter E., additional, Cassity, Evan P., additional, Trautner, Barbara, additional, Pandit, Lavannya M., additional, Knowlton, Kirk U., additional, Leither, Lindsay, additional, Matthay, Michael A., additional, Rogers, Angela J., additional, Drake, Wonder, additional, Jones, Beatrice, additional, Poulakou, Garyfallia, additional, Syrigos, Konstantinos N., additional, Fernandez-Cruz, Eduardo, additional, Di Natale, Marisa, additional, Almasri, Eyad, additional, Balerdi-Sarasola, Leire, additional, Bhagani, Sanjay R., additional, Boyle, Katherine L., additional, Casey, Jonathan D., additional, Chen, Peter, additional, Douin, David J., additional, Files, D. Clark, additional, Günthard, Huldrych F., additional, Hite, R. Duncan, additional, Hyzy, Robert C., additional, Khan, Akram, additional, Kibirige, Moses, additional, Kidega, Robert, additional, Kimuli, Ivan, additional, Kiweewa, Francis, additional, Jensen, Jens Ulrik Stæhr, additional, Leshnower, Bradley G., additional, Lutaakome, Joseph K., additional, Manian, Prasad, additional, Menon, Vidya, additional, Morales-Rull, Jose Luis, additional, O'Mahony, Darragh, additional, Overcash, J. Scott, additional, Ramachandruni, Srikant, additional, Steingrub, Jay S., additional, Taha, Hassan S., additional, Waters, Michael, additional, Young, Barnaby E., additional, Phillips, Andrew N., additional, Murray, Daniel D., additional, Jensen, Tomas O., additional, Padilla, Maria L., additional, Sahner, David, additional, Shaw-Saliba, Katy, additional, Dewar, Robin L., additional, Teitelbaum, Marc, additional, Natarajan, Ven, additional, Rehman, M. Tauseef, additional, Pett, Sarah, additional, Hudson, Fleur, additional, Touloumi, Giota, additional, Brown, Samuel M., additional, Self, Wesley H., additional, Chang, Christina C., additional, Sanchez, Adriana, additional, Weintrob, Amy C., additional, Hatlen, Timothy, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Reilly, Cavan S., additional, Garbes, Pedro, additional, Esser, Mark T., additional, Templeton, Alison, additional, Babiker, Abdel G., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Higgs, Elizabeth S., additional, Kan, Virginia, additional, Matthews, Gail, additional, Thompson, B. Taylor, additional, Neaton, James D., additional, Lane, H. Clifford, additional, and Lundgren, Jens, additional

Published
2022
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31. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D, primary, Babiker, Abdel G, additional, Baker, Jason V, additional, Barkauskas, Christina E, additional, Brown, Samuel M, additional, Chang, Christina C, additional, Davey, Victoria J, additional, Gelijns, Annetine C, additional, Ginde, Adit A, additional, Grund, Birgit, additional, Higgs, Elizabeth, additional, Hudson, Fleur, additional, Kan, Virginia L, additional, Lane, H Clifford, additional, Murray, Thomas A, additional, Paredes, Roger, additional, Parmar, Mahesh KB, additional, Pett, Sarah, additional, Phillips, Andrew N, additional, Polizzotto, Mark N, additional, Reilly, Cavan, additional, Sandkovsky, Uriel, additional, Sharma, Shweta, additional, Teitelbaum, Marc, additional, Thompson, B Taylor, additional, Young, Barnaby E, additional, Neaton, James D, additional, and Lundgren, Jens D, additional

Published
2021
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32. sj-pdf-1-ctj-10.1177_17407745211049829 – Supplemental material for Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D, Babiker, Abdel G, Baker, Jason V, Barkauskas, Christina E, Brown, Samuel M, Chang, Christina C, Davey, Victoria J, Gelijns, Annetine C, Ginde, Adit A, Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L, Lane, H Clifford, Murray, Thomas A, Paredes, Roger, Parmar, Mahesh KB, Pett, Sarah, Phillips, Andrew N, Polizzotto, Mark N, Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B Taylor, Young, Barnaby E, Neaton, James D, and Lundgren, Jens D

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, sj-pdf-1-ctj-10.1177_17407745211049829 for Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3) by Daniel D Murray, Abdel G Babiker, Jason V Baker, Christina E Barkauskas, Samuel M Brown, Christina C Chang, Victoria J Davey, Annetine C Gelijns, Adit A Ginde, Birgit Grund, Elizabeth Higgs, Fleur Hudson, Virginia L Kan, H Clifford Lane, Thomas A Murray, Roger Paredes, Mahesh KB Parmar, Sarah Pett, Andrew N Phillips, Mark N Polizzotto, Cavan Reilly, Uriel Sandkovsky, Shweta Sharma, Marc Teitelbaum, B Taylor Thompson, Barnaby E Young, James D Neaton and Jens D Lundgren in Clinical Trials

Published
2021
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33. sj-docx-3-ctj-10.1177_17407745211049829 – Supplemental material for Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D, Babiker, Abdel G, Baker, Jason V, Barkauskas, Christina E, Brown, Samuel M, Chang, Christina C, Davey, Victoria J, Gelijns, Annetine C, Ginde, Adit A, Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L, Lane, H Clifford, Murray, Thomas A, Paredes, Roger, Parmar, Mahesh KB, Pett, Sarah, Phillips, Andrew N, Polizzotto, Mark N, Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B Taylor, Young, Barnaby E, Neaton, James D, and Lundgren, Jens D

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, sj-docx-3-ctj-10.1177_17407745211049829 for Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3) by Daniel D Murray, Abdel G Babiker, Jason V Baker, Christina E Barkauskas, Samuel M Brown, Christina C Chang, Victoria J Davey, Annetine C Gelijns, Adit A Ginde, Birgit Grund, Elizabeth Higgs, Fleur Hudson, Virginia L Kan, H Clifford Lane, Thomas A Murray, Roger Paredes, Mahesh KB Parmar, Sarah Pett, Andrew N Phillips, Mark N Polizzotto, Cavan Reilly, Uriel Sandkovsky, Shweta Sharma, Marc Teitelbaum, B Taylor Thompson, Barnaby E Young, James D Neaton and Jens D Lundgren in Clinical Trials

Published
2021
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34. sj-pdf-2-ctj-10.1177_17407745211049829 – Supplemental material for Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D, Babiker, Abdel G, Baker, Jason V, Barkauskas, Christina E, Brown, Samuel M, Chang, Christina C, Davey, Victoria J, Gelijns, Annetine C, Ginde, Adit A, Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L, Lane, H Clifford, Murray, Thomas A, Paredes, Roger, Parmar, Mahesh KB, Pett, Sarah, Phillips, Andrew N, Polizzotto, Mark N, Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B Taylor, Young, Barnaby E, Neaton, James D, and Lundgren, Jens D

Subjects
FOS: Clinical medicine, 160807 Sociological Methodology and Research Methods, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, FOS: Sociology
Abstract

Supplemental material, sj-pdf-2-ctj-10.1177_17407745211049829 for Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3) by Daniel D Murray, Abdel G Babiker, Jason V Baker, Christina E Barkauskas, Samuel M Brown, Christina C Chang, Victoria J Davey, Annetine C Gelijns, Adit A Ginde, Birgit Grund, Elizabeth Higgs, Fleur Hudson, Virginia L Kan, H Clifford Lane, Thomas A Murray, Roger Paredes, Mahesh KB Parmar, Sarah Pett, Andrew N Phillips, Mark N Polizzotto, Cavan Reilly, Uriel Sandkovsky, Shweta Sharma, Marc Teitelbaum, B Taylor Thompson, Barnaby E Young, James D Neaton and Jens D Lundgren in Clinical Trials

Published
2021
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35. Rescinding community mitigation strategies in an influenza pandemic

Author

Davey, Victoria J. and Glass, Robert J.

Subjects
Company distribution practices, Influenza -- Control, Influenza -- Causes of, Influenza -- Development and progression, Influenza -- Research, Influenza viruses -- Health aspects, Influenza viruses -- Distribution, Influenza viruses -- Research
Abstract

Using a networked, agent-based computational model of a stylized community, we evaluated thresholds for rescinding 2 community mitigation strategies after an influenza pandemic. We ended child sequestering or all-community sequestering [...]

Published
2008

40. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D., primary, Babiker, Abdel G., additional, Baker, Jason V., additional, Barkauskas, Christina E., additional, Brown, Samuel M., additional, Chang, Christina C., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Ginde, Adit A., additional, Grund, Birgit, additional, Higgs, Elizabeth, additional, Hudson, Fleur, additional, Kan, Virginia L., additional, Lane, H. Clifford, additional, Murray, Thomas A., additional, Paredes, Roger, additional, Parmar, Mahesh K.B., additional, Pett, Sarah, additional, Phillips, Andrew N., additional, Polizzotto, Mark N., additional, Reilly, Cavan, additional, Sandkovsky, Uriel, additional, Sharma, Shweta, additional, Teitelbaum, Marc, additional, Thompson, B. Taylor, additional, Young, Barnaby E., additional, Neaton, James D., additional, and Lundgren, Jens D., additional

Published
2020
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41. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3).

Author

Murray, Daniel D, Babiker, Abdel G, Baker, Jason V, Barkauskas, Christina E, Brown, Samuel M, Chang, Christina C, Davey, Victoria J, Gelijns, Annetine C, Ginde, Adit A, Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L, Lane, H Clifford, Murray, Thomas A, Paredes, Roger, Parmar, Mahesh KB, Pett, Sarah, Phillips, Andrew N, and Polizzotto, Mark N

Subjects
DRUG efficacy, SARS-CoV-2, COVID-19, CLINICAL trials, ANTIVIRAL agents, MEDICAL protocols
Abstract

Background/aims: Safe and effective therapies for COVID-19 are urgently needed. In order to meet this need, the Accelerating COVID-19 Therapeutic Interventions and Vaccines public–private partnership initiated the Therapeutics for Inpatients with COVID-19. Therapeutics for Inpatients with COVID-19 is a multi-arm, multi-stage platform master protocol, which facilitates the rapid evaluation of the safety and efficacy of novel candidate antiviral therapeutic agents for adults hospitalized with COVID-19. Five agents have so far entered the protocol, with rapid answers already provided for three of these. Other agents are expected to enter the protocol throughout 2021. This protocol contains a number of key design and implementation features that, along with challenges faced by the protocol team, are presented and discussed. Methods: Three clinical trial networks, encompassing a global network of clinical sites, participated in the protocol development and implementation. Therapeutics for Inpatients with COVID-19 utilizes a multi-arm, multi-stage design with an agile and robust approach to futility and safety evaluation at 300 patients enrolled, with subsequent expansion to full sample size and an expanded target population if the agent shows an acceptable safety profile and evidence of efficacy. Rapid recruitment to multiple agents is enabled through the sharing of placebo, the confining of agent-specific information to protocol appendices, and modular consent forms. In collaboration with the Food and Drug Administration, a thorough safety data collection and Data and Safety Monitoring Board schedule was developed for the study of potential therapeutic agents with limited in-human data in hospitalized patients with COVID-19. Results: As of 8 August 2021, five agents have entered the Therapeutics for Inpatients with COVID-19 master protocol and a total of 1909 participants have been randomized to one of these agents or matching placebo. There were a number of challenges faced by the study team that needed to be overcome in order to successfully implement Therapeutics for Inpatients with COVID-19 across a global network of sites. These included ensuring drug supply and reliable recruitment allowing for changing infection rates across the global network of sites, the need to balance the collection of data and samples without overburdening clinical staff and obtaining regulatory approvals across a global network of sites. Conclusion: Through a robust multi-network partnership, the Therapeutics for Inpatients with COVID-19 protocol has been successfully used across a global network of sites for rapid generation of efficacy data on multiple novel antiviral agents. The protocol design and implementation features used in this protocol, and the approaches to address challenges, will have broader applicability. Mechanisms to facilitate improved communication and harmonization among country-specific regulatory bodies are required to achieve the full potential of this approach in dealing with a global outbreak. [ABSTRACT FROM AUTHOR]

Published
2022
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44. A phase I/II trial of zidovudine, interferon-alpha, and granulocyte-macrophage colony-stimulating factor in the treatment of human immunodeficiency virus type I infection

Author

Davey, Richard T., Jr., Davey, Victoria J., Metcalf, Julia A., Zurlo, John J., Kovacs, Joseph A., Falloon, Judith, Polis, Michael A., Zunich, Kathryn M., Masur, Henry, and Lane, H. Clifford

Subjects
HIV infection -- Drug therapy, Neutropenia -- Drug therapy, Neutropenia -- Causes of, HIV infection -- Physiological aspects, Granulocyte-macrophage colony stimulating factor -- Health aspects, Zidovudine -- Health aspects, Interferon alpha -- Health aspects, Health
Abstract

Drugs used to treat bacterial infection of the blood and certain types of blood and solid tissue cancers are now being considered for treatment of infection with human immunodeficiency virus type I (HIV-I), which causes AIDS. The combined use of agents with different mechanisms of action, side effects, or patterns of resistance may be effective in eliminating HIV-I infection. If the antiviral actions of drugs are synergistic, or greater when combined than when used alone, it may be possible to administer lower doses of each drug. In addition, optimal doses of drugs with similar mechanisms of actions, but different toxic effects can be used in combined regimens. Viral resistance to a drug may develop less readily with combined regimens than with single drug therapy. The antiviral agent zidovudine interferes with the production of genetic material of HIV-I, whereas interferon-alpha (IFN-alpha) prevents the production of the virus. Zidovudine and IFN-alpha were reported to be synergistic, but cause neutropenia, a severe decrease in the number of neutrophils (a type of white blood cell). Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that can be produced artificially in large amounts using recombinant technology. GM-CSF was shown to improve neutropenia in patients with cancer, AIDS, or bone marrow suppression. The side effects of GM-CSF are mild, related to dosage, and include fever and bone pain. The effectiveness of GM-CSF in treating neutropenia associated with combined zidovudine and IFN-alpha treatment was assessed in 24 HIV-I-infected patients. The blood levels of p24 antigen, a measure of HIV-I infection, decreased by more than 70 percent in five patients with this antigen. Combined treatment with zidovudine, IFN-alpha, and GM-CSF was associated with lymphokine-like side effects: loss of appetite, weight loss, fatigue, and a decrease in red blood cells. However, GM-CSF improved neutropenia without reducing the antiviral action of zidovudine and IFN-alpha. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

50. EFFECTIVENESS OF SMALLPOX VACCINATION TO PREVENT MPOX IN MILITARY PERSONNEL.

Author

Titanji, Boghuma K., Eick-Cost, Angelia, Epstein, Lauren, Wells, Natalie, Smith, Jeremy, Stahlman, Shauna L., Balajee, Abirami, Pyarajan, Saiju, Woods, Chris W., Holodniy, Mark, Partan, Elizabeth J., Davey, Victoria J., Bonomo, Robert A., Yinong Young-Xu, and Marconi, Vincent C.

Published
2023

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