A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-COV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with Covid-19

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-2067
IRB Number:2020V0205
Actively Enrolling
Interventional
Phase 1
August 17, 2020
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
A patient must meet the following criteria to be eligible for inclusion in the study:
1. Is male or female ≥18 years of age (or country’s legal age of adulthood) at randomization
2. Is experiencing >1 of the following symptoms at randomization: fever, cough, shortness of
breath
3. Has symptoms consistent with COVID-19, as determined by investigator.
days before randomization
4. Is willing and able to provide informed consent signed by study patient or legally
acceptable representative
5. Is willing and able to comply with study procedures, including providing samples for viral
shedding testing

Exclusion Criteria
A patient who meets any of the following criteria will be excluded from the study:
1. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at
randomization, due to COVID-19
2. Has participated, or is participating, in a clinical research study evaluating COVID-19
convalescent plasma.
3. Has a history of COVID-19 investigational or Emergency Use Authorization
4. Current use of any COVID-19 investigational or EUA-approved treatment.
5. Pregnant or breastfeeding women
6. Continued sexual activity in women of childbearing potential (WOCBP)* or sexually
active men who are unwilling to practice highly effective contraception prior to the initial
dose/start

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Amy Wigglesworth
Phone Number: 601-815-3464
Email: ajwigglesworth@umc.edu
Principal Investigator:Marshall, Gailen D, M.D.Ph.D., M.D., Ph.D.
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