COVID-19 Clinical Trial
Official title:
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
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.
n/a
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