Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Sponsor
Lisa Barrett
Study ID
NCT04321993
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib (janus kinase inhibitor) — DRUG
    Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.
  • Remdesivir (antiviral) + barictinib (janus kinase inhibitor) — DRUG
    Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total). Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.
  • Remdesivir (antiviral) — DRUG
    Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total).
  • Tocilizumab (interleukin 6 inhibitor) — DRUG
    Tocilizumab will be administered as a single IV infusion over one hour. Dosage will be 8 mg/kg total bodyweight up to a maximum of 800 mg.

Study Details

Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.

Key Dates

Start date
Apr 17, 2020
Status verified
Sep 2023
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
363 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Moderate and severe, not critical disease
  • Experimental: Remdesivir
    Moderate and severe, not critical disease
  • Experimental: Remdesivir + baricitinib
    Moderate and severe, not critical disease
  • Experimental: Tocilizumab
    Severe, critical disease
  • No Intervention: Clinical standard of care
    Moderate and severe, not critical disease AND severe, critical disease as applicable

Primary Outcome Measure

Clinical status of subject at day 15 (on a 7 point ordinal scale). [ Time Frame: Up to 15 days ]

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