Status:
TERMINATED
Tofacitinib for Treatment of Moderate COVID-19
Lead Sponsor:
Yale University
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 pneumo...
Detailed Description
The purpose of this randomized, double blinded, placebo controlled Phase 2b study is to assess the efficacy and safety of tofacitinib in hospitalized adult (18-99 years old) male and female patients w...
Eligibility Criteria
Inclusion
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercially available or public health assay prior to Day 1.
- Participants with evidence of pneumonia assessed by radiographic imaging (chest x ray or chest CT scan) AND Requiring ≥ 3L O2 OR ≥ 2L O2 and hsCRP \> 70 mg/L
- Participants who are hospitalized and receiving supportive care for COVID-19.
- Participant (or legally authorized representative/surrogate) capable of giving signed informed consent.
Exclusion
- Medical Conditions:
- Require mechanical ventilation or ECMO on Day 1 at the time of randomization.
- Have current, or history of, venous thromboembolism (deep vein thrombosis or pulmonary embolism).
- Have a personal or first-degree family history of blood clotting disorders.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (eg, azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
- Females of child bearing potential who are pregnant or breastfeeding
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Anticipated survival \< 72 hours as assessed by the Investigator.
- Infection History:
- • Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) including but not limited to:
- Secondary bacterial pneumonia;
- Active herpes zoster infection;
- Known active tuberculosis or history of inadequately treated tuberculosis;
- Known HBV, HCV, or HIV.
- Prior/Concomitant Therapy:
- Have received any of the following treatment regimens specified in the timeframes outlined below:
- Within 4 weeks prior to the first dose of study intervention:
- Prior treatment with any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (eg, tocilizumab) or IL-1 inhibitors (eg, anakinra);
- Prior treatment with any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer.
- Within 48 hours prior to the first dose of study intervention:
- o Treatment with herbal supplements.
- Received \>/= 20 mg/day of prednisone or equivalent for \>/=14 consecutive days in the 4 weeks prior to screening.
- Diagnostic Assessments:
- Severe hepatic impairment, defined as Child-Pugh class C.
- Severe anemia (hemoglobin \<8 g/dL).
- ANY of the following abnormalities in clinical laboratory tests at screening, confirmed by a single repeat, if deemed necessary:
- WBC \<1000/mm3
- Absolute lymphocyte count \<500 cells/mm3;
- Absolute neutrophil count \<1000 cells/mm3.
- Alanine transaminase/aspartate transaminase (ALT/AST) \> 5 times the upper limit of normal;
- Estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m2);
- Other Exclusions:
- Known allergy to tofacitinib.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04415151
Start Date
October 14 2020
End Date
February 28 2021
Last Update
March 28 2025
Active Locations (1)
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1
Yale New Haven Health System
New Haven, Connecticut, United States, 06511