Covid-19 Living Data

Trial NCT04355767
Publication SIREN-C3PO - 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 participants : Convalescent plasma=257 Placebo=254
	Characteristics of participants N= 511 Mean age : NR 237 males Severity : Mild: n= */ Asymptomatic: n=0 Number of vaccinated participants: NR
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 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	Some concerns
General comment	In addition to the published article, the prospective registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The primary and secondary outcomes in the article reflect those in the registry. Safety outcomes were not included in the registry, but were included in the protocol. Trial inclusion criteria relating to risk factors for severe disease changed slightly over the course of the study, informed by evolving understanding of the disease. Recruitment to the trial was stopped after the second planned interim analysis, which indicated the pre-specified threshold for futility had been reached, and so the study did not achieve its target sample size. This study was updated on September 8th, 2022 with data extracted from the registry.