Trial CTRI/2020/05/025209
Publication Ray Y, Nat Commun (2022) (published paper)
Dates: 2020-05-31 to 2020-10-12
Funding: Public/non profit (Council of Scientific Industrial Research (CSIR), Govt. of India and Fondation Botnar)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / India Follow-up duration (days): 30 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Convalescent plasma 200 mL IV once a day on two consecutive days. |
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Control
Standard care | |
Participants | |
Randomized participants : Standard care=40 Convalescent plasma=40 | |
Characteristics of participants N= 80 Mean age : NR 57 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=80 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register To compare ‘all cause’ mortality. To identify the immune correlates for response to plasma therapy. Timepoints: Discharge. Discharge/death. Day 0, Day 3, Day 7 after admission. | |
In the report All-cause mortality on day 30 after enrolment and identification of immunological correlates of response to CPT, if any. | |
Documents available |
Protocol Yes. In English Statistical plan NR 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 |
High |
General comment |
In addition to the published article, the preprint, the protocol and the trial registry was used in data extraction and assessment of risk of bias. The statistical analysis plan was not available. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome (all cause mortality) timepoint does not reflect the timepoint reported in the published report.
This study was updated on March 2nd, 2022 with data extracted from the published report. |