Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy
NCT ID: NCT04412252
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2020-07-06
2020-10-18
Brief Summary
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Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1.
Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate.
Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60.
An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tofacitinib
Participants will receive tofacitinib 10 mg twice per day for 14 days and standard of care therapy.
Tofacitinib
10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
Placebo
Participants will receive tofacitinib-matching placebo twice per day for 14 days and standard of care therapy.
Placebo
Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days
Interventions
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Tofacitinib
10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
Placebo
Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection prior to Day 1.
* Participants with evidence of COVID-19 pneumonia assessed by radiographic imaging (chest x ray or chest CT scan).
Exclusion Criteria
* Have history of or current thrombosis. Only if current thrombosis is suspected, imaging testing is recommended (e.g. CTPA or per local guidance) to exclude thrombosis.
* Have a personal or first degree family history of blood clotting disorders.
* Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g. azathioprine, cyclosporine).
* Participants with any current malignancy or lymphoproliferative disorders that requires active treatment.
* Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19).
* Severe hepatic impairment, defined as Child-Pugh class C.
* Severe anemia (hemoglobin \< 8 g/dL)
* ANY of the following abnormalities in clinical lab tests at screening, confirmed by a single repeat, if deemed necessary: ALC \< 500 cells/mm3, ANC \< 1000 cells/mm3
* Known allergy to tofacitinib
18 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hartford Hospital (HH)
Hartford, Connecticut, United States
University of Iowa Hospitals & Clinics Investigational Drug Services
Iowa City, Iowa, United States
University of Iowa
Iowa City, Iowa, United States
LSUHSC-Shreveport
Shreveport, Louisiana, United States
Ochsner LSU Health Shreveport Academic Medical Center
Shreveport, Louisiana, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921377
Identifier Type: -
Identifier Source: org_study_id