Status:
WITHDRAWN
Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy
Lead Sponsor:
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pn...
Eligibility Criteria
Inclusion
- Male or female between 18 and 65 years. A female is eligible if she is not pregnant or breastfeeding. WOCBP must use 2 highly effective forms of contraception.
- 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
- Require HFNC, non-invasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04412252
Start Date
July 6 2020
End Date
October 18 2020
Last Update
July 31 2020
Active Locations (6)
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1
Hartford Hospital (HH)
Hartford, Connecticut, United States, 06102
2
University of Iowa Hospitals & Clinics Investigational Drug Services
Iowa City, Iowa, United States, 52242
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
LSUHSC-Shreveport
Shreveport, Louisiana, United States, 71103