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

About this Study

A study to evaluate the effects of monoclonal antibodies in adult outpatients with COVID-19 and its efficacy in preventing progression to moderate/severe COVID-19.

Sponsor Protocol ID:R10933-10987-COV-2069
IRB Number:2020V0234
Closed for Enrollment
Interventional
Phase 3
August 17, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria
1. 18 years of age and above 
2. Asymptomatic household contact with sustained exposure.
3. Subject anticipates living in the same household with the index case until study day 29
4. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline

Exclusion Criteria
1. Active respiratory or non-respiratory symptoms consistent with COVID-19
2. History of respiratory illness 
3. Nursing home resident
4. Any physical examination findings, and/or history of any illness, concomitant medication sor 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 subject by their participation in the
study.
5. Current hospitalization or was hospitalized (for >24 hours) for any reason within 30 days of the screening visit
6. Has a history of significant multiple and/or severe allergies.
7. Treatment with another investigational agent in the last 30 days

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Courtney Gomillia
Phone Number: 601-815-9522
Email: CEGomillia@umc.edu
Principal Investigator:Jose Lucar Lloveras
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