Trial NCT04589949, NCT04621123
Publication COMPILE home - Millat-Martinez P, Nat Commun (2022) (published paper)
Dates: 2020-11-01 to 2021-07-13
Funding: Mixed (ZONMW (the Netherlands), SUPPORT-E, YoMeCorono, The Fight AIDS and Infectious Diseases Foundation with funding from the pharmaceutical company Grifols S.A.)
Conflict of interest: No
Methods | |
RCT Blinding: triple blinding | |
Location :
Multicenter / Netherlands, Spain Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Convalescent plasma 200-300 mL IV infusion single dose |
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Control
Placebo Non-convalescent plasma (CoV-Early) or 0.9% saline solution (COnV-ert) | |
Participants | |
Randomized participants : Convalescent plasma=398 Placebo=399 | |
Characteristics of participants N= 797 Mean age : NR 522 males Severity : Mild: n= 797/ Asymptomatic: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register CoV-Early trial: Highest disease status [ Time Frame: 28 days following transfusion of convP or FFP ] Highest disease status on the 5-point ordinal disease severity scale in the convP group will be compared with the FFP group; COnV-ert trial: 1) Hospitalization rate (safety and efficacy) [ Time Frame: Day 28 ] Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing the rate of hospitalization in non-hospitalised mild or moderate COVID-19 patients; 2)SARS-CoV-2 viral load (safety and efficacy) [ Time Frame: Day 7 ] Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing SARS-CoV-2 viral load at day 7, measured by quantitative RT-PCR (RT-qPCR) in non-hospitalised mild or moderate COVID-19 patients. | |
In the report A 5-point disease severity scale (fully recovered by day 7 or not, hospital or ICU admission and death) and a composite of hospitalization or death. | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
General comment |
In addition to the final rerpot, the pre-print article, the trial registries, the protocol and supplementary appendices were used in data extraction and assessment of risk of bias. The article reports the results of two similar trials (CoV-Early and COnV-ert), which started to pool outcome data when less than 20% of their target sample sizes had been randomized, and whose study teams agreed upon a minimal set of data required to analyze the primary and secondary endpoints. The co-primary outcomes in the article reflect the primary outcome in one trial registry and a secondary outcome in the other. The trials (n = 797) did not achieve their combined target sample sizes (n = 1,164) due to early termination of recruitment because of increasing uptake of vaccinations and recommendations for use of monoclonal antibodies.
The Alemany A, Lancet Respir Med, 2022 study (COnV-ert) is extracted elsewhere and reports on longer follow up outcomes up to Day 60. Gharbharan A, Clin Microbiol Infect, 2022 results are included in this trial and only reports results up to Day28. This study was updated on November 18th, 2022 with data extracted from the final publication. |