Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Covid-19
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19
- Participants will provide informed consent prior to initiation of any study procedures.
- Participants understand and agrees to comply with planned study procedures.
- Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen.
- Ongoing illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging
- Blood oxygen saturation (SpO2) = 94% on room air
- Requiring supplemental oxygen
- Requiring mechanical ventilation or ECMO
- Women of childbearing potential must agree to either abstinence or use of at least one primary form of contraception
- Agrees not to participate in another interventional trial for the treatment of COVID-19 through Day 60
- Agrees not to participate in another interventional trial for the treatment of COVID-19 through Day 60
- Exception 1: Participant may co-enroll in ACTIV-4 (ACTIV-4A and ACTIV-4C)
- Exception 2: Participants in ACTIV-2 who have been hospitalized may be enrolled in ACTIV-1 as long as ACTIV-2 study therapy has been discontinued. They will remain in ACTIV-2 follow-up
- Exception 3: If participant is already participating in a COVID-19 vaccine trial but develops COVID-19 disease that requires hospitalization, participant is eligible for this study, assuming all other inclusion/exclusion criteria are met.
You may not be eligible for this study if the following are true:
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- Liver Blood Tests results are abnormal (ALT or AST >10 times the upper limit of normal)
- Estimated glomerular filtration rate (eGFR) <30 mL/min
- Neutropenia
- Lymphopenia
- Pregnancy or breast feeding
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
- Known allergy to any study medication
- Received targeted immune-modulator treatments
- Known or suspected history of untreated tuberculosis (TB).
- Known or suspected serious, active bacterial, fungal, or viral infection
- Have received any live vaccine (or live attenuated) within 3 months
- Has any advanced organ dysfunction
- Severe hepatic impairment
- Known severe heart failure
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.