Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy

NCT04412252

Last updated date
Study Location
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COVID-19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

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


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy
Official Title  ICMJE A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE SAFETY AND EFFICACY OF TOFACITINIB IN HOSPITALIZED PARTICIPANTS WITH COVID-19 PNEUMONIA WHO ARE RECEIVING STANDARD OF CARE THERAPY
Brief Summary

The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.

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 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1.

Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate.

Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60.

An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Tofacitinib
    10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
    Other Name: xeljanz
  • Other: Placebo
    Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days
Study Arms  ICMJE
  • Experimental: Tofacitinib
    Participants will receive tofacitinib 10 mg twice per day for 14 days and standard of care therapy.
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Placebo
    Participants will receive tofacitinib-matching placebo twice per day for 14 days and standard of care therapy.
    Intervention: Other: 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: June 4, 2020)
240
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2020)
265
Estimated Study Completion Date  ICMJE October 18, 2020
Estimated Primary Completion Date September 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04412252
Other Study ID Numbers  ICMJE A3921377
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP