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TD-0903 for ALI Associated with COVID-19
||Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated with COVID-19
Covid-19, Acute Lung Injury
||Nicholas Hill, MD
Part 2 is a randomized, double-blind, parallel-group study evaluating efficacy and safety of one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo in hospitalized subjects with confirmed symptomatic COVID-19 who require supplemental oxygen. Approximately 99 subjects per group (198 subjects total) will be enrolled in Part 2.
Eligible subjects will be stratified by baseline age (≤ 60 vs > 60 years) and concurrent use of antiviral medications (yes or no) (e.g., remdesivir) at baseline. Within each stratum, subjects will be randomized 1:1 to receive placebo or TD-0903. Approximately 20% of participants will be enrolled with a baseline clinical status score of six (NIPPV or high flow oxygen device) based on the 8-point ordinal scale (Table 3). The study drug will be administered once-daily or twice daily in divided doses (as determined by results from Study TD-0903-0183 and from Part 1 of this study) for up to 7 days or until discharge from the hospital, whichever is earlier. Subjects will be followed for up to 28 days or until death, whichever is earlier.
Sparse sampling for assessment of TD-0903 plasma concentrations will be collected for population PK analysis.
- Onset of COVID-19 -related symptoms > 2 days and < 14 days prior to hospital admission
- Age 18 to 80 years old
- Hospitalized (or documentation of a plan to admit to the hospital if the subject is in an emergency department) and requiring supplemental oxygen to maintain saturation > 90%
- Subjects currently receiving invasive mechanical ventilation.
- Presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer)
- Evidence of serious active infections other than COVID-19
Subjects will be assessed daily while hospitalized, with evaluations performed according to the Protocol Schedule of Events. In Part 2, if subjects are discharged from the hospital before Days 14, 21 or 28 and are known to be alive at discharge, they will undergo a telephonic study visit on Days 14, 21, and/or 28 to provide data relating to clinical status, adverse events and concomitant medications. Subjects will be on study for 28 days or until death occurs. There are no scans. On study days where a number of blood samples are collected over the day, a cannula (thin plastic tube inserted into a vein) may be used to collect blood samples, which will be taken during the first week of hospitalization.