J Clin Invest. 2021 Nov 17:e155114. doi: 10.1172/JCI155114. Online ahead of print.
ABSTRACT
BACKGROUND: Antibody-based strategies for COVID-19 have shown promise in prevention and treatment of early disease. COVID-19 convalescent plasma (CCP) has been widely used but results from randomized trials supporting its benefit in hospitalized patients with pneumonia are limited. Here, we assess the efficacy of CCP in severely ill, hospitalized adults with COVID-19 pneumonia.
METHODS: We performed a randomized control trial (PennCCP2), in 80 adults hospitalized with COVID-19 pneumonia, comparing up to 2 units of locally-sourced CCP plus standard care vs. standard care alone. The primary efficacy endpoint was comparison of a clinical severity score. Key secondary outcomes include 14- and 28-day mortality, 14- and 28-day WHO8 score, duration of supplemental oxygenation or mechanical ventilation, respiratory SARS-CoV-2 RNA, and anti-SARS-CoV-2 antibodies.
RESULTS: 80 hospitalized adults with confirmed COVID-19 pneumonia were enrolled at median day 6 of symptoms and day 1 of hospitalization; 60% were anti-SARS-CoV-2 antibody seronegative. Participants had a median of 3 comorbidities, including risk factors for severe COVID-19 and immunosuppression. CCP treatment was safe and conferred significant benefit by clinical severity score (MED (IQR) 10 (5.5,30) vs. 7 (2.75,12.25), p=0.037) and 28-day mortality (n=10, 26% vs. n=2, 5%; p=0.013). All other pre-specified outcome measures showed weak evidence towards benefit of CCP.
CONCLUSIONS: Two units of locally-sourced CCP administered early in hospitalization to majority seronegative participants conferred a significant benefit in clinical severity score and 28-day mortality. Results suggest CCP may benefit select populations, especially those with comorbidities who are treated early.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT04397757FUNDING. University of Pennsylvania.
PMID:34788233 | DOI:10.1172/JCI155114