Study Details
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
This is a phase 3 randomized, double-blind, placebo-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection in geographic areas with an active COVID-19 outbreak. All subjects in the study will be household contacts with sustained close exposure (at least 48 hours) with an individual with SARS-CoV-2 infection (index case) but who are themselves asymptomatic (having no active respiratory or
non-respiratory symptoms consistent with COVID-19) at the time of screening. Randomization will be performed by individual study subjects, not by households.
Sample Size:
Cohort A: Approximately 1700 adult subjects with a negative rapid SARS-CoV-2 RT-PCR at baseline will be enrolled.
Cohort B: Approximately 300 adult subjects with a positive rapid SARS-CoV-2 RT-PCR at baseline will be enrolled.
Target Population:
Asymptomatic, healthy adults who are household contacts to an individual with a positive SARS-CoV-2 RT-PCR assay (index case)
Approximately 2000 subjects will be enrolled.
For each subject, there are 3 study periods: a 1-day screening/baseline period, a 1-month EAP, and a 7-month follow-up period after the end of the EAP.
Study Drug: REGN10987 and REGN10933
Dose/Route/Schedule: 1200 mg (600 mg of each mAb) /SC / single dose on day 1
Placebo: Matching solution
Route/Schedule: SC / single dose on day 1
Cohort A Primary Efficacy Objectives
• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR
• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR
Cohort A Primary Safety Objective
• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo
Cohort A Secondary Objectives
• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR
• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic SARS-CoV-2 infection confirmed by RT-qPCR
• To evaluate the impact of REGN10933+REGN10987 compared to placebo on the duration of signs and symptoms in subjects with symptomatic SARS-CoV-2 infection confirmed by RT-qPCR
• To evaluate the impact of REGN10933+REGN10987 compared to placebo on SARS-CoV-2 RT-qPCR test results
• To evaluate the impact of REGN10933+REGN10987 compared to placebo
− On health care utilization
− On absenteeism from daily responsibilities
• To characterize the drug concentration-time profiles of REGN10933 and REGN10987 in serum and selected pharmacokinetic (PK) parameters.
• To assess the immunogenicity of REGN10933 and REGN10987
• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration in seropositive subjects
• To estimate the incidence and severity of symptomatic SARS-CoV-2 infection over time, including the period following study drug treatment, in REGN10933+REGN10987-treated seronegative and seropositive subjects compared with placebo-treated subjects
Cohort B Secondary Objectives
• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing development of:
− Symptomatic SARS-CoV-2 infection (strict-term)
− Symptomatic SARS-CoV-2 infection (broad-term)
• To evaluate the impact of REGN10933+REGN10987 compared to placebo on the duration of signs and symptoms in subjects with symptomatic SARS‑CoV-2 infection confirmed by RT-qPCR
• To evaluate the impact of REGN10933+REGN10987 compared to placebo on SARS-CoV-2 RT-qPCR test results
• To evaluate the impact of REGN10933+REGN10987 compared to placebo in SARS-CoV-2 infection:
− On health care utilization
− On absenteeism from daily responsibilities
• To characterize the drug concentration-time profiles of REGN10933 and REGN10987 and selected PK parameters in serum
• To assess the immunogenicity of REGN10933 and REGN10987
• To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration in both seronegative and seropositive subjects
• To estimate the incidence and severity of symptomatic SARS-CoV-2 infection over time, including the period following study drug treatment, in REGN10933+REGN10987-treated seronegative and seropositive subjects compared with placebo-treated subjects