COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04412252

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com

2020-06-02

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - 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).

- 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

2

Pfizer

18

75

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Clinical status using ordinal scale

None

Phase 2

[{"arm_notes": "", "treatment_id": 1300, "treatment_name": "Tofacitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]