Covid-19 Living Data

Trial NCT04425629
Publication Weinreich DM, N Engl J Med (2020) (published paper)
Dates: 2020-06-16 to 2020-08-13
Funding: Mixed (Regeneron Pharmaceuticals; Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services)
Conflict of interest: Yes

Methods
	RCT Blinding:
	Location : Multicenter / USA Follow-up duration (days): 29
Inclusion criteria	Outpatients aged 18 years of age or older SARS-CoV-2–positive test result received no more than 72 hours before randomization and symptom onset no more than 7 days before randomization maintains O2 saturation ≥93% on room air.
Exclusion criteria	Admitted to a hospital for COVID-19 prior to randomization, or hospitalized for any reason at randomization has participated, or is participating in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
Interventions
	Treatment REGN-COV2 2.4 g/8.0 g in a 250 mL normal saline solution IV once off, over a period of 1 hour.
	Control Placebo
Participants
	Randomized participants : REGN-COV2=182 Placebo=93
	Characteristics of participants N= 275 Mean age : NR 134 males Severity : Mild: n= 275/ Asymptomatic: n= Number of vaccinated participants: NR
Primary outcome
	In the register Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through Day 29 ] Proportion of patients with infusion-related reactions [ Time Frame: Through Day 4 ] Proportion of patients with hypersensitivity reactions
	In the report Time-weighted average change in viral load from baseline (day 1) through day 7 and the percentage of patients with at least one Covid-19–related medically attended visit through day 29
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
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 article, the trial registry, protocol, statistical analysis plan and supplementary materials were used in data extraction. This is an interim analysis reporting early Phase I/II results from an ongoing operationally seamless (continual enrollment) Phase I/II/III trial. The data cutoff for this interim analysis was September 4, 2020. There were no substantive differences between the published article and the trial registry, protocol and statistical analysis plan in population, procedures and interventions. Several Phase I/II clinical outcomes included in the protocol were not reported. A fourth Phase II arm, REGN10989 included in the protocol dependent upon regulatory clearance, was not reported. The population in the interim report did not achieve the pre-stated Phase I/II sample size. Quote: "One center was found to have violations of Good Clinical Practice guidelines (not related to the collection of data on efficacy or safety end points) and was withdrawn from the trial after analyses had been completed." The study is updated under a new publication Weinreich D, medrxiv, 2021. We present only data on outcome serious adverse events since it was reported in Weinreich D, medrxiv, 2021.