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7. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients

Author

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

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

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

Published
2021

15. Contributors

Author

Ahmad, Imran, Alexander, Ronda E., Artime, Carlos A., Aziz, Michael F., Baker, Paul A., Ball, Christine M., Basañez, Irving, Beaman, Shawn T., Behringer, Elizabeth C., Bello, Jacqueline A., Benumof, Jonathan L., Berkow, Lauren C., Brambrink, Ansgar M., Braude, Darren Alan, Cameron, Staci D., Cattano, Davide, Cavallone, Laura F., Chi, T. Linda, Chrimes, Nicholas, Cohen, Edmond, Cohen, Neal H., Cook, Tim M., Cooper, Richard M., Diemunsch, Pierre, Doyle, D. John, DuCanto, James, Duggan, Laura V., Dutton, Richard P., El-Boghdadly, Kariem, Ellard, Louise, Feinleib, Jessica L., Ferson, David Z., Foley, Lorraine J., Gaitini, Luis, Galgon, Richard E., Gibbs, Michael Alfred, MME, Robert Greif, Grissom, Thomas E., Guzman-Reyes, Sara, Hagberg, Carin A., Hayanga, Heather K., MD, Thomas Heidegger, Higgs, Andy, Hodge, Caleb B., Hung, Orlando, Ibrahim, Haitham, Jagannathan, Narasimhan, Jain, Ranu R., Johnson, Liane B., Kastner, Mark, Jr., Jeffrey P. Keck, Jr., P. Allan Klock, Knight, Joshua B., Kovacs, George, Kristensen, Michael Seltz, Langeron, Olivier, Lee, Sarah A., Lindsay, Helen A., J. Mark, Lynette, Mark, Nathan D., Marshall, Stuart D., Mathew, Reeba, Matioc, Adrian, McClelland, Andrew C., III, Joseph H. McIsaac, McNarry, Alistair F., Mirsky, David M., Mohamed, Basma, Moon, Tiffany Sun, Mort, Thomas C., Mosier, Jarrod M., Nabecker, Sabine, Nagrebetsky, Alexander, Naruse, Robert, Nekhendzy, Vladimir, O’Grady, Kevin F., Ogunnaike, Babatunde, Oh, Matthew W., Olivar, Hernando P., Osborn, Irene P., O’Sullivan, Ellen, Palaniappan, Dhamodaran, Parotto, Matteo, MBBS, Anil Patel, Patel, Bela, Piacentini, Alberto G.G., Poole, Oliver J., Potnuru, Paul, Quinlan, Joseph J., Ramirez-Chapman, Ana Lisa, Roberts, Fiona, Rosenblatt, William H., Ross, Christopher, Roy, Soham, Samet, Ron E., Schiff, Jan-Henrik, Schmitz, Bettina U., Sharar, Sam R., Sharofi, Saimir, Shifteh, Keivan, Soliman, Maged, Sparrow, Kathryn, Sridhar, Srikanth, Steuerwald, Michael Thomas, Straker, Tracey, Subramanya, Sriharsha, Suresh, Maya S., Teoh, Wendy H., Urdaneta, Felipe, Vaida, Sonia, Jr., Manuel C. Vallejo, Vanga, Naveen, Walker, Kathryn K., Walther, Andreas, Warner, Mark T., Wilkinson, David J., Wilson, William C., Wong, David T., Zakowski, Mark, and Zdravkovic, Marko

Published
2023
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18. Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial

Author

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

Abstract

IMPORTANCE: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. OBJECTIVE: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. DESIGN, SETTING, AND PARTICIPANTS: CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. INTERVENTIONS: A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). MAIN OUTCOMES AND MEASURES: The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. RESULTS: Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). CONCLUSIONS AND RELEVANCE: In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04364737

Published
2022
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25. Periodic Limb Movement Disorder in Cancer Patient

Author

Mathew, Reeba, primary, Faiz, Saadia, additional, Remmert, Brenda, additional, Mahoney, Stephen, additional, Pacheco, Guadalupe, additional, Keus, Leendert, additional, Bashoura, Lara, additional, and Balachandran, Diwakar, additional

Published
2011
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27. ECTOPIC VARICES.

Author

Faiz, Saadia A, primary, Mathew, Reeba, additional, Warner, Mark, additional, and Estrada-y-Martin, Rosa, additional

Published
2006
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