Outpatient convalescent plasma therapy for high-risk patients with early COVID-19: a randomized placebo-controlled trial

Arvind Gharbharan, Carlijn Jordans, the CoV-Early study group, Lisa Zwaginga, Grigorios Papageorgiou, Nan van Geloven, Peter van Wijngaarden, Jan den Hollander, Faiz Karim, Elena van Leeuwen-Segarceanu, Robert Soetekouw, Jolanda Lammers, Douwe Postma, Linda Kampschreur, Geert Groeneveld, Francis Swaneveld, C. Ellen van der Schoot, Hannelore Götz, Bart Haagmans, Marion KoopmansSusanne Bogers, Corine Geurtsvankessel, Jaap Jan Zwaginga, Casper Rokx, Bart Rijnders*

*Corresponding author for this work

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Abstract

Objectives: The potential benefit of convalescent plasma (CP) therapy for coronavirus disease 2019 (COVID-19) is highest when administered early after symptom onset. Our objective was to determine the effectiveness of CP therapy in improving the disease course of COVID-19 among high-risk outpatients. Methods: A multicentre, double-blind randomized trial was conducted comparing 300 mL of CP with non-CP. Patients were ≥50 years, were symptomatic for <8 days, had confirmed RT-PCR or antigen test result for COVID-19 and had at least one risk factor for severe COVID-19. The primary endpoint was the highest score on a 5-point ordinal scale ranging from fully recovered (score = 1) or not (score = 2) on day 7, over hospital admission (score = 3), intensive care unit admission (score = 4) and death (score = 5) in the 28 days following randomization. Secondary endpoints were hospital admission, symptom duration and viral RNA excretion. Results: After the enrolment of 421 patients and the transfusion in 416 patients, recruitment was discontinued when the countrywide vaccination uptake in those aged >50 years was 80%. Patients had a median age of 60 years, symptoms for 5 days, and 207 of 416 patients received CP therapy. During the 28 day follow-up, 28 patients were hospitalized and two died. The OR for an improved disease severity score with CP was 0.86 (95% credible interval, 0.59–1.22). The OR was 0.58 (95% CI, 0.33–1.02) for patients with ≤5 days of symptoms. The hazard ratio for hospital admission was 0.61 (95% CI, 0.28–1.34). No difference was found in viral RNA excretion or in the duration of symptoms. Conclusions: In patients with early COVID-19, CP therapy did not improve the 5-point disease severity score.

Original languageEnglish
JournalClinical Microbiology and Infection
DOIs
Publication statusE-pub ahead of print - Aug 2022

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