convalescent plasma treatment (n=257) vs. placebo (n=254)
randomized controlled trial
some concerns about risk of bias
COVID-19 convalescent plasma
One unit (250 mL) of ABO-compatible COVID-19 convalescent plasma.
Placebo
250 mL of normal saline (colored with a parenteral multivitamin concentrate to resemble plasma).
COVID 19 outpatients
=< 18 years with one or more symptoms of COVID-19 illness and laboratory-confirmed SARS-Cov-2 infection, at least one study defined risk factor for severe COVID-19 illness, clinical team deems stable for outpatient management without supplemental oxygen, CP available at the site at the time of enrollment, duration of symptoms =< 7 days at ED presentation, informed consent from subject.
Single-blind.
Multicenter: 48 hospital emergency departments across the United States.
Trial enrollment was halted after the second planned interim analysis of the primary outcome indicated that the a priori stopping threshold for futility had been reached on the basis of a posterior predictive probability of success of 0.042.
CONV-ERT, 2021 NCT04621123
convalescent plasma treatment (n=188) vs. placebo (n=160)
randomized controlled trial
low risk of bias
convalescent plasma
anti-SARS-CoV-2 MBT plasma plus SMT will undergo an ABO compatibility test and will receive a single infusion of 200 to 300 ml
placebo
200 to 300ml of sterile saline solution 0.9%.
COVID 19 outpatients
double blind
4 centers, Spain
The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccin
CoV-Early (Gharbharan), 2022 NCT04589949
convalescent plasma treatment (n=207) vs. placebo (n=209)
randomized controlled trial
low risk of bias
convalescent plasma
placebo
regular plasma
COVID 19 outpatients
double blind
netherlands
phase 3. Based on the recommendation by the DSMB (rapid uptake of vaccination and effective monoclonal antibodies available for high risk outpatients), the study was terminated on the 13th of July 2021 before the planned sample size of 690 was reached