Study Stopped
Due to the pursuit of other SARS-CoV-2-related research including alternative trials with tofacitinib, this trial was canceled prior to subject enrollment.
Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy
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
1 other identifier
interventional
N/A
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2020
Shorter than P25 for phase_2 covid19
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
July 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2020
CompletedJuly 31, 2020
July 1, 2020
2 months
May 30, 2020
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical status using ordinal scale
Death or respiratory failure (1, 2, or 3, on an 8-point ordinal scale of disease severity) at Day 28. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Day 28
Secondary Outcomes (4)
Clinical status using ordinal scale
Day 14
Status of alive and not using mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
Day 14 and Day 28
Status of discharged or not requiring supplemental oxygen
Day 28
Mortality
Day 60
Study Arms (2)
Tofacitinib
EXPERIMENTALParticipants will receive tofacitinib 10 mg twice per day for 14 days and standard of care therapy.
Placebo
PLACEBO COMPARATORParticipants will receive tofacitinib-matching placebo twice per day for 14 days and standard of care therapy.
Interventions
10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (6)
Hartford Hospital (HH)
Hartford, Connecticut, 06102, United States
University of Iowa Hospitals & Clinics Investigational Drug Services
Iowa City, Iowa, 52242, United States
University of Iowa
Iowa City, Iowa, 52242, United States
LSUHSC-Shreveport
Shreveport, Louisiana, 71103, United States
Ochsner LSU Health Shreveport Academic Medical Center
Shreveport, Louisiana, 71103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2020
First Posted
June 2, 2020
Study Start
July 6, 2020
Primary Completion
September 16, 2020
Study Completion
October 18, 2020
Last Updated
July 31, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
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/data\_requests.