Randomized Master Protocol for Immune Modulators for Treating COVID-19

About this Study

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of
moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and
hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at
the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on
other research findings. Comparisons of the agents among themselves is not a research objective.

Sponsor Protocol ID:ACTIV-1 IM
IRB Number:pending
Actively Enrolling
Interventional
Observational/Not Applicable
October 23, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
Yes

Inclusion Criteria
1. Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19.
2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study
procedures.
3. Subject (or legally authorized representative) understands and agrees to comply with planned study
procedures.
4. Male or non-pregnant female adults ≥18 years of age at time of enrollment.
5. Women of childbearing potential must agree to either abstinence or use at least one primary form of
contraception not including hormonal contraception from the time of screening through Day 60.
6. Agrees to not participate in another interventional trial for the treatment of COVID-19 through Day 60.

Exclusion Criteria
1. Pregnancy or breast feeding.
2. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72
hours.
3. Known allergy to any study medication.

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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