Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

Primary Objective: - 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 - To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo

Official Title

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

Keywords

Healthy Participants Asymptomatic Individuals at risk of exposure to SARS-CoV-2 Household Contacts of a Person Infected with SARS-CoV-2 Infection REGN10933 + REGN10987

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Asymptomatic household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). To be included in the study, participants must be randomized within 96 hours of collection of the index cases' positive SARS-COV-2 diagnostic test sample
  2. Participant anticipates living in the same household with the index case until study day 29
  3. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including participants who are healthy or have a chronic, stable medical condition
  4. Willing and able to comply with study visits and study-related procedures/assessments.
  5. Provide informed consent signed by study participant or legally acceptable representative.

You CAN'T join if...

  1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening
  2. Participant has lived with individuals who have had previous SARS-CoV-2 infection
  3. Active respiratory or non-respiratory symptoms consistent with COVID-19
  4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion of the investigator within the prior month to screening
  5. Nursing home resident
  6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Locations

  • Regeneron Study Site accepting new patients
    Los Angeles California 90095 United States
  • Regeneron Study Site accepting new patients
    San Francisco California 94127 United States
  • Regeneron Study Site accepting new patients
    Los Angeles California 90035 United States
  • Regeneron Study Site accepting new patients
    Los Angeles California 90036 United States
  • Regeneron Study Site not yet accepting patients
    San Diego California 92108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT04452318
Phase
Phase 3
Study Type
Interventional
Last Updated