Covid-19 Living Data

Trial NCT04518410
Publication ACTIV-2 - Evering TH, Open Forum Infect Dis (2021) (unpublished results)
Dates: 2021-01-01 to 2021-07-30
Funding: Not reported/unclear
Conflict of interest: Yes

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / USA, Brazil, South Africa, Mexico, Argentina and the Philippines Follow-up duration (days): 28
Inclusion criteria	At high risk of clinical progression (i.e., age ≥ 60 years or presence of other medical conditions) within 10 days of symptom onset Positive test for SARS-CoV-2
Exclusion criteria	History of or current hospitalization for COVID-19 For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected > 240 hours prior to study entry Current need for hospitalization or immediate medical attention Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study. Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines) Known allergy/sensitivity or hypersensitivity to study drug or placebo Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study Currently pregnant or breastfeeding
Interventions
	Treatment BRII-196/BRII-198 1000 mg IV infusion of each single dose
	Control Placebo
Participants
	Randomized participants : BRII-196/BRII-198 =418 Placebo=419
	Characteristics of participants N= 837 Mean age : NR 0 males Severity : Mild: n= / Asymptomatic: n= Number of vaccinated participants: NR
Primary outcome
	In the register 1) COVID-19 symptom duration (Phase 2) [ Time Frame: Up to Day 28 ] Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3) 2) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 3 ] Measured as quantification (3) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 7 ] Measured as quantification (4) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 14 ] Measured as quantification (5) Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2) [ Time Frame: Thru Day 28 ] Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3) [ Time Frame: Thru Day 28 ] Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
	In the report Hospitalization and/or death through day 28
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
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	The published abstract and the study registry were used in data extraction. This study is part of the the ACTIV-2 platform trial.