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Clinical Trial 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.


Clinical Trial Description

Part 1 of the study includes up to 3 ascending dose cohorts, each comprised of 8 subjects (6 receiving TD-0903 and 2 receiving placebo). Part 2 of the study will evaluate one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo. Part 2 is targeting 198 subjects total. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04402866
Study type Interventional
Source Theravance Biopharma
Contact
Status Completed
Phase Phase 2
Start date June 24, 2020
Completion date April 21, 2021

See also
  Status Clinical Trial Phase
Completed NCT04350736 - First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19 Phase 1