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:

  • Conditions:
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19
    2. Participants will provide informed consent prior to initiation of any study procedures.
    3. Participants understand and agrees to comply with planned study procedures.
    4. 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.
    5. 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
    6. Women of childbearing potential must agree to either abstinence or use of at least one primary form of contraception
    7. Agrees not to participate in another interventional trial for the treatment of COVID-19 through Day 60
    8. 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:

    1. Liver Blood Tests results are abnormal (ALT or AST >10 times the upper limit of normal)
    2. Estimated glomerular filtration rate (eGFR) <30 mL/min
    3. Neutropenia
    4. Lymphopenia
    5. Pregnancy or breast feeding
    6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
    7. Known allergy to any study medication
    8. Received targeted immune-modulator treatments
    9. Known or suspected history of untreated tuberculosis (TB).
    10. Known or suspected serious, active bacterial, fungal, or viral infection
    11. Have received any live vaccine (or live attenuated) within 3 months
    12. Has any advanced organ dysfunction
    13. Severe hepatic impairment
    14. Known severe heart failure

If you are registered as a volunteer, please login to the dashboard to send referrals.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.