Covid-19 Living Data

Trial NCT04364737
Publication CONTAIN COVID-19 - Ortigoza MB, JAMA Intern Med (2021) (published paper)
Dates: 2020-04-17 to 2021-03-15
Funding: Public/non profit (Philanthropic funds to New York University and Montefiore Medical Center/Albert Einstein College of Medicine; grant from the G. Harold and Leila Y. Mathers Foundation (Dr Pirofski); a Damon Runyon Cancer Research Foundation Physician-Scientist award (Dr Upadhyay); grants from the NCATS/NIH Centers for Translational Science Awards (CTSA); a contract with the Biomedical Advanced Research and Development Authority (BARDA) through the Department of Health and Human Services and the Operation Warp Speed interagency program; Irma and Abram S. Croll Charitable Trust; the Michael Price Foundation; Montefiore COVID-19 Emergency Fund. )
Conflict of interest: Yes

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Adults aged 18 years or older hospitalized for 3 days or less or with symptoms of respiratory illness for 7 days or less (to include patients with presumably early phases of disease) required noninvasive oxygen supplementation positive nasopharyngeal SARS-CoV-2 reverse-transcriptase polymerase-chain-reaction test
Exclusion criteria	Receipt of pooled immunoglobulin in the preceding 30 days contraindication to transfusion invasive mechanical ventilation or extracorporeal membrane oxygenation volume overload considered unlikely to survive past 72 hours based on investigator assessment receipt of a COVID-19 vaccine (after vaccines were available) Patients whose clinical outcomes were deemed not assessable after hospital discharge.
Interventions
	Treatment Convalescent plasma 250 mL once-off intravenously infused at a rate of less than or equal to 500 mL/h once-off
	Control Placebo
Participants
	Randomized participants : Placebo=473 Convalescent plasma=468
	Characteristics of participants N= 941 Mean age : NR 556 males Severity : Mild: n=0 / Moderate: n=673 / Severe: n=268 Critical: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register Score on the WHO 11-point ordinal scale for clinical improvement at 14 days [ Time Frame: 14 days post randomization ]
	In the report Clinical status based on the participant scores on the 11-point WHO Ordinal Scale for Clinical Improvement (WHO scale) 14 days after randomization
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 registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There was no change from the trial registration in the intervention and control treatments. The primary outcome in the article reflected that in the registry. Several secondary outcomes are not reported because analysis has not yet been completed. Enrollment was terminated because of slowing recruitment, the need for rapid reporting, and a 0.2% probability that the study would meet criteria for success if enrollment continued to 1000 participants. Consequently the study (n = 941) did not achieve its anticipated sample size (n = 1000). The study was updated on September 14th, 2022 with data extracted from the registry.