Status:
COMPLETED
Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
Pfizer
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in patients with COVI...
Detailed Description
COVID-19 is a viral disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that can cause severe pneumonia and ARDS. Respiratory viral load may peak withi...
Eligibility Criteria
Inclusion
- Male or female participants older than 18 years
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) prior to Day 1.
- Evidence of pneumonia assessed by radiographic imaging (chest x-ray or chest CT scan).
- Hospitalized for less than 72 hours and receiving supportive care for COVID-19
Exclusion
- Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization
- History of or known current thrombosis. Only if current thrombosis is suspected by the investigator, imaging testing is recommended (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 (eg, azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
- Severe hepatic impairment, defined as Child-Pugh class C.
- Severe anemia (hemoglobin \<8 g/dL).
- Absolute lymphocyte count \<500 cells/mm;
- Absolute neutrophil count \<1000 cells/mm.
- Known allergy to tofacitinib.
- 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.
- Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) including but not limited to: active herpes zoster infection; known active tuberculosis or history of inadequately treated tuberculosis; known B hepatitis, C hepatitis, or HIV.
- Have received any of these within 4 weeks prior to the first dose of study intervention: any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (eg, tocilizumab) or IL-1 inhibitors (eg, anakinra) within the past 30 days; any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer.
- Have received estrogen-containing contraception or treatment with herbal supplements within 48 hours prior to the first dose of study intervention.
- Have received treatment with corticosteroids equivalent to prednisone or methylprednisolone \>20 mg/day for equal or more than 14 consecutive days prior to screening.
- Current participation in other trials.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2021
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT04469114
Start Date
September 16 2020
End Date
January 9 2021
Last Update
August 9 2021
Active Locations (17)
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1
Centro de Pesquisa Clínica do Coração
Aracaju, Brazil
2
Hospital Universitário São Francisco de Assis Na Providência de Deu
Bragança Paulista, Brazil
3
Irmandade do Sr. Bom Jesus dos Passos da Santa Casa de Misericórdia de Bragança Paulista
Bragança Paulista, Brazil
4
Hospital do Coração do Brasil
Brasília, Brazil