Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19

This is an adaptive, phase 1/2/3, randomized, double-blinded, placebo-controlled master protocol to evaluate the efficacy, safety, and tolerability of REGN10933+REGN10987 combination therapy and REGN10989 monotherapy in adult outpatients (ie, ambulatory patients) with COVID-19, including asymptomatic patients with SARS-CoV-2 infection.

Inova Fairfax Medical Campus
3300 Gallows Rd.
Falls Church, Virginia 22042

• Male or female ≥ 18yrs
• Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RTPCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
• Meets 1 of the following 2 criteria:
  1. Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤7 days before randomization OR
  2. Asymptomatic Cohort (Phase 2): Meets all of the following: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization; Has had no positive SARS-CoV-2 test results from a sample collected > 7 days prior to randomization; Has had no known contact (of any duration) with an individual who has confirmed COVID-19 or confirmed positive SARS-CoV-2 test results >14 days prior to randomization.
• Maintains O2 saturation ≥93% on room air
• Willing and able to provide signed informed consent by patient or LAR
• Willing and able to comply with study procedures, including providing samples for viral shedding testing

• Was/is hospitalized prior to randomization due to COVID-19
• Participated or participating in a clinical research study for COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or IVIG within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to screening
• 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 EUA approved treatments where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (whichever is longer) prior to screening
• Known allergy or hypersensitivity to components of study drug
• Discharged/planned discharge to a quarantine center
• Pregnant or breastfeeding women
• Continued sexual activity in women of childbearing potential (WOCBP) or sexually active men who are unwilling to practice highly effective contraception prior to initial dose/start of first treatment, during study, and at least 6 months after last dose. See protocol for full list of acceptable methods

ClinicalTrials.gov Identifier: NCT04425629