Trial NCT04433910; EudraCT 2020-001310-38
Publication CAPSID - Koerper S, J Clin Invest (2021) (published paper)
Dates: 2020-08-30 to 2020-12-24
Funding: Public/non profit (Bundesministerium fuer Gesundheit (German Federal Ministry of Health))
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Germany Follow-up duration (days): 60 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Convalescent plasma 1 transfusion unit on days 1, 3 and 5. Median total volume = 846 ml (IQR 824-855 ml) |
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Control
Standard care | |
Participants | |
Randomized participants : Convalescent plasma=53 Standard care=52 | |
Characteristics of participants N= 105 Mean age : NR 77 males Severity : Mild: n=7 / Moderate: n=13 / Severe: n=49 Critical: n=36 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Composite endpoint of survival and no longer fulfilling criteria of severe COVID-19. [ Time Frame: Day 21 ] | |
In the report Dichotomous composite outcome of survival and no longer requiring ventilation support or ICU treatment and no tachypnea (i.e., respiratory rate <30 breaths/minute) on day 21. | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
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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 |
Some concerns |
General comment |
In addition to the published journal and pre-print articles, the trial registry and supplementary appendices (including statistical analysis plan) were used in data extraction and assessment of risk of bias. No protocol was available. There were no substantive differences between the prospective registry and the publication in population, procedures or interventions. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Some outcomes from the registry are not reported in the paper. The analysis for this report is based on an interim data-cut off on April 28, 2021. The study achieved its targeted sample size.
This trial was updated on October 6th, 2021 with data from the peer-reviewed journal publication. |