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

Publication Date



JAMA Internal Medicine


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

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: Identifier: NCT04364737.


Adult, Aged, Blood Component Transfusion, COVID-19, Critical Illness, Double-Blind Method, Female, Hospitalization, Humans, Immunization, Passive, Male, Middle Aged, Respiration, Artificial, Treatment Outcome, United States, COVID-19 Serotherapy



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