Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia
NCT04469114
ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Male or female participants older than 18 years
2. 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.
3. Evidence of pneumonia assessed by radiographic imaging (chest x-ray or chest CT scan).
4. Hospitalized for less than 72 hours and receiving supportive care for COVID-19
1. Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal
membrane oxygenation (ECMO) on Day 1 at the time of randomization
2. 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.
3. Have a personal or first-degree family history of blood clotting disorders.
4. Participants who are immunocompromised, with known immunodeficiencies, or taking
potent immunosuppressive agents (eg, azathioprine, cyclosporine).
5. Participants with any current malignancy or lymphoproliferative disorders that
requires active treatment
6. Severe hepatic impairment, defined as Child-Pugh class C.
7. Severe anemia (hemoglobin <8 g/dL).
8. Absolute lymphocyte count <500 cells/mm;
9. Absolute neutrophil count <1000 cells/mm.
10. Known allergy to tofacitinib.
11. 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.
12. 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.
13. 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.
14. Have received estrogen-containing contraception or treatment with herbal supplements
within 48 hours prior to the first dose of study intervention.
15. Have received treatment with corticosteroids equivalent to prednisone or
methylprednisolone >20 mg/day for equal or more than 14 consecutive days prior to
screening.
16. Current participation in other trials.
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Descriptive Information | |||||||
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Brief Title ICMJE | Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia | ||||||
Official Title ICMJE | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Trial of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia | ||||||
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 COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia. | ||||||
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 within 5 days after onset, while symptoms are still mild. Many patients rapidly (within 1 to 2 weeks of infection) develop dyspnea and pneumonia and require hospitalization for respiratory support. Preliminary clinical data from COVID-19 patients indicate that severe symptoms with SARS-CoV-2 infection are associated with an exaggerated immune response driven by interleukin (IL)-6 IL-10, tumor necrosis factor (TNF)?, and other cytokines. The ultimate result is progressive destruction of the alveolar epithelium leading to pneumonia and/or ARDS. Moreover, the exudative phase of ARDS is thought to be due to an influx of myeloid cells (neutrophils and macrophages) and elevations of inflammatory cytokines, with higher levels of both IL-6 and IL-8 levels being correlated with increased mortality. Therefore, immunomodulatory therapy may be beneficial in reducing the deleterious effects of lung inflammation and mitigating progressive lung injury. Tofacitinib is an inhibitor of Janus kinase (JAKs) 1 and 3, with partial selectivity to JAK 2. Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and ARDS in patients with COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia. 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 72h hours after admission to the hospital to determine eligibility. Eligible participants will be randomized on Day 1 to the tofacitinib plus standard of care treatment group or the placebo plus standard of care treatment group in a 1:1 ratio, stratified by site and need for oxygen Participants will receive treatment for up to 14 days or until discharge from the hospital, whichever is earlier. Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 14 and on Day 28. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Covid19 | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE | 260 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | March 1, 2021 | ||||||
Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Brazil | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04469114 | ||||||
Other Study ID Numbers ICMJE | 34810620.0.1001.0071 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hospital Israelita Albert Einstein | ||||||
Study Sponsor ICMJE | Hospital Israelita Albert Einstein | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Hospital Israelita Albert Einstein | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |