Trial NCT04355767
Publication Korley F, N Engl J Med, 2021 (published paper)
Dates: 2020-08-11 to 2021-02-28
Funding: Public/non profit (National Heart, Lung, and Blood Institute and the National Institute of Neurological Disorders and Stroke of the National Institutes of Health; the Biomedical Advanced Research and Development Authority; the Operation Warp Speed interagency program.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Multicenter / USA Follow-up duration (days): 30 | |
| Inclusion criteria | SARS-CoV-2 infection as confirmed by nucleic acid assay; onset of symptoms within 7 days before enrollment; either 50 years of age or older or had one or more risk factors for disease progression (hypertension; diabetes; coronary artery disease; chronic lung disease; chronic kidney disease; immunosuppression; sickle cell disease, and body mass index >30); written informed consent. |
| Exclusion criteria | Younger than 18 years of age; prisoners or wards of the state; patients who were deemed to have an inability to complete follow-up assessments; history of adverse reactions from blood-product transfusion; received any blood product within the past 120 days; not eligible to receive up to 250 ml of fluid; received another investigational treatment for Covid-19, including anti–SARS-CoV-2 monoclonal antibodies or vaccination. |
| Interventions | |
| Treatment
Convalescent plasma 1 unit ABO-compatible convalescent plasma over ≥30 minutes, once-off |
|
| Control
Placebo | |
| Participants | |
| Randomized 511 participants (n1=257 / n2= 254) | |
| Characteristics of participants N=511 Mean age : NR 237 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Number of patients with disease progression [ Time Frame: 15 days ]. Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization. | |
| In the report Disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
|
| 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 |