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

Gharbharan, A.; Jordans, C.; Zwaginga, L.; Papageorgiou, G.; Geloven, N. van; Wijngaarden, P. van; Hollander, J. den; Karim, F.; Leeuwen-Segarceanu, E. van; Soetekouw, R.; Lammers, J.; Postma, D.; Kampschreur, L.; Groeneveld, G.; Swaneveld, F.; Schoot, C.E. van der; Gotz, H.; Haagmans, B.; Koopmans, M.; Bogers, S.; Geurtsvankessel, C.; Zwaginga, J.J.; Rokx, C.; Rijnders, B.; CoV-Early study grp

doi:doi:10.1016/j.cmi.2022.08.005

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...Show moreObjectives: 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 dis-continued 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. Arvind Gharbharan, Clin Microbiol Infect 2023;29:208 (c) 2022 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).Show less

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