School of Medicine Publications and Presentations
Document Type
Article
Publication Date
12-13-2021
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
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.
Recommended Citation
Ortigoza, M. B., Yoon, H., Goldfeld, K. S., Troxel, A. B., Daily, J. P., Wu, Y., Li, Y., Wu, D., Cobb, G. F., Baptiste, G., O'Keeffe, M., Corpuz, M. O., Ostrosky-Zeichner, L., Amin, A., Zacharioudakis, I. M., Jayaweera, D. T., Wu, Y., Philley, J. V., Devine, M. S., Desruisseaux, M. S., … Hendrickson, J. E. (2021). Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial. JAMA internal medicine, 10.1001/jamainternmed.2021.6850. Advance online publication. https://doi.org/10.1001/jamainternmed.2021.6850
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Publication Title
JAMA Internal Medicine
DOI
10.1001/jamainternmed.2021.6850
Academic Level
faculty
Mentor/PI Department
Internal Medicine
Comments
© 2021 Ortigoza MB et al.