Trial NCT04359810
Publication O Donnell M, J Clin Invest, 2021 (preprint)
Dates: 2020-04-21 to 2020-11-27
Funding: Not reported/unclear (Amazon Foundation)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: | |
| Location :
Multicenter / Brazil, USA Follow-up duration (days): 28 | |
| Inclusion criteria | Hospitalized patients aged ≥18 years; evidence of SARS-CoV-2 infection by polymerase chain reaction of nasopharyngeal, oropharyngeal swab or tracheal aspirate sample within 14 days of randomization; infiltrates on chest imaging; oxygen saturation ≤ 94% on room air or requirement for supplemental oxygen (including noninvasive positive pressure ventilation or high flow supplemental oxygen), IMV or extracorporeal membrane oxygenation (ECMO) at the time of screening. |
| Exclusion criteria | Participation in another clinical trial of anti-viral agent(s) for COVID-19; receipt of any anti-viral agent with possible activity against SARS-CoV-2 within 24 hours of randomization; duration of IMV or ECMO ≥ 5 days at time of screening; severe multi-organ failure; and a history of prior reactions to transfusion blood products. |
| Interventions | |
| Treatment
Convalescent plasma 1 unit of plasma (~200-250 ml) IV over approximately 2 hours |
|
| Control
Standard plasma ( / ) | |
| Participants | |
| Randomized 223 participants (n1=150 / n2= 73) | |
| Characteristics of participants N=223 Mean age : NR 147 males Severity : Mild: n=* / Moderate: n=8/ Severe: n=182 Critical: n=28 | |
| Primary outcome | |
| In the register Day 28 severity outcome [ Time Frame: Up to 28 days ] | |
| In the report Clinical status at day 28 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 published/pre-print article, the study registry, the protocol and SAP was used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The initial primary outcome was time-to-clinical-improvement. However, the primary outcome of the study was amended to clinical status at day 28, and time-to-clinical-improvement became a secondary outcome. This change was made on August 8th, 2020 (at which point 31% [70/223] of the trial population was enrolled) without any knowledge of outcome data, and the protocol was updated accordingly with approval of the data safety and monitoring board. In patients who were discharged from the hospital alive and not reachable for day 28 assessment, the last available clinical status was carried forward for the primary analysis. No patients were known to have died following discharge from hospital. On April 30th,2021, we received additional information from authors on this study. This study was updated with data from contact with authors and the published report on May 17th, 2021. |