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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Pfizer
Study ID
NCT04412252
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
  • Placebo — OTHER
    Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days

Study Details

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.

Key Dates

Start date
Jul 6, 2020
Status verified
Jul 2020
Primary completion
Sep 16, 2020
Completion
Oct 18, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    Participants will receive tofacitinib 10 mg twice per day for 14 days and standard of care therapy.
  • Placebo Comparator: Placebo
    Participants will receive tofacitinib-matching placebo twice per day for 14 days and standard of care therapy.

Primary Outcome Measure

Clinical status using ordinal scale [ Time Frame: Day 28 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Hartford Hospital (HH)HartfordConnecticut06102-
University of IowaIowa CityIowa52242-
University of Iowa Hospitals & Clinics Investigational Drug ServicesIowa CityIowa52242-
LSUHSC-ShreveportShreveportLouisiana71103-
Ochsner LSU Health Shreveport Academic Medical CenterShreveportLouisiana71103-
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Hartford, CT

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Hartford Hospital (HH)· Hartford, CTUniversity of Iowa· Iowa City, IAUniversity of Iowa Hospitals & Clinics Investigational Drug Services· Iowa City, IALSUHSC-Shreveport· Shreveport, LAOchsner LSU Health Shreveport Academic Medical Center· Shreveport, LAUniversity Hospitals Cleveland Medical Center· Cleveland, OH

Related Studies