CompletedPhase 2

TD-0903 for ALI Associated With COVID-19

United States235 participantsStarted 2020-06-24

Plain-language summary

This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.

Who can participate

Age range18 Years – 80 Years

SexALL

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Exclusion criteria

✕. Methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment
✕. Azathioprine or cyclophosphamide within 12 weeks prior to enrollment
✕. Monoclonal antibodies targeting B cells (e.g., rituximab) within 12 weeks prior to enrollment
✕. Tumor necrosis factor-alpha (TNFα)) inhibitors within 4 weeks prior to enrollment

What they're measuring

Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28

Timeframe: Randomization to Day 28

Trial details

NCT IDNCT04402866

SponsorTheravance Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-21

Results submitted2022-02-25

View on ClinicalTrials.gov More Acute Lung Injury (ALI) Associated With COVID-19 trials