Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

Research Team

Eligibility Criteria

Inclusion Criteria

Admitted to a hospital with symptoms suggestive of COVID-19.

Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.

Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.

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Treatment Details

Interventions

Baricitinib (Janus Kinase (JAK) Inhibitor)
Remdesivir (Antiviral Agent)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Remdesivir plus BaricitinibExperimental Treatment2 Interventions

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

Group II: Remdesivir plus PlaceboPlacebo Group2 Interventions

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

Baricitinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Olumiant for: