Tofacitinib for Treatment of Moderate COVID-19

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04415151
Phase
PHASE2
Status
Terminated

Conditions

  • COVID-19 Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 10 mg — DRUG
    Tofacitinib will be administered in a dose of 10 mg twice daily by mouth (PO BID) until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.
  • Placebo — DRUG
    Matching placebo tablets will be administered.

Study Details

The purpose of this randomized, double blinded, placebo controlled study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) patients with SARS-CoV-2 and pneumonia who require supplemental oxygen and have serologic markers of inflammation but do not need mechanical ventilation.

Key Dates

Start date
Oct 14, 2020
Status verified
Mar 2025
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    Tofacitinib will be administered in a dose of 10 mg PO BID until return to their clinical baseline (as defined by supplementary oxygen requirement), and then will continue to be administered at 5 mg PO BID for a total treatment duration of 14 days.
  • Placebo Comparator: Placebo
    Matching placebo will be administered.

Primary Outcome Measure

Disease Severity [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Health SystemNew HavenConnecticut06511-

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Yale New Haven Health System· New Haven, CT

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