Trial NCT04375098
Publication Balcells M, PLoS Med (2021) (published paper)
Dates: 2020-05-10 to 2020-07-18
Funding: Mixed (Fondo de Adopción Tecnológica SiEmpre, SOFOFA Hub, and Ministerio de Ciencia, Tecnología, Conocimiento e Innovación, Chile, donation from ENEL Chile S.A.)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Chile Follow-up duration (days): 30 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Convalescent plasma Two 200 mL transfusion with the second transfusion administered 24 hours after the first dose |
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Control
Late CP The deferred plasma group received convalescent plasma only if a prespecified worsening respiratory function criterion was met during hospitalization (PaO2/FiO2 < 200) or if the patient still required hospitalization for symptomatic COVID-19 >7 days after enrollment. | |
Participants | |
Randomized participants : Late CP=30 Convalescent plasma=28 | |
Characteristics of participants N= 58 Mean age : NR 29 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=31 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization | |
In the report Composite of mechanical ventilation, hospitalization >14 days or in-hospital death. | |
Documents available |
Protocol Yes. In English Statistical plan Yes 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 |
High |
General comment |
In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size (n=58). There is no change from the trial registration in the intervention and control treatments, nor the primary outcome. There were some discrepancies between some secondary outcomes stated in the registry versus the report.
On December 14th,2020, we received additional information from authors on this study, we updated the study results based on authors reply. The study was updated on March 25th, 2021 after publication of the study report. |