Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia

NCT04469114

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Covid19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 and receiving supportive care for COVID-19

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Covid19Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia
NCT04469114
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: Tofacitinib 10 mg
    Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge
  • Drug: Placebo
    Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge
Study Arms  ICMJE
  • Experimental: Tofacitinib
    Tofacitinib 10mg twice daily for 14 days or until hospital discharge
    Intervention: Drug: Tofacitinib 10 mg
  • Placebo Comparator: Placebo
    Placebo twice daily for 14 days or until hospital discharge
    Intervention: Drug: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2020)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date December 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 and receiving supportive care for COVID-19

Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Otavio Berwanger, MD, PhD+551121515915[email protected]
Contact: Patricia O Guimaraes, MD, PhD+551121515915[email protected]
Listed Location Countries  ICMJE Not Provided
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
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