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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
235
Theravance Biopharma Investigational Site
Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28
An RFD was defined as a day that a participant was alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) from randomization through Day 28. The number of RFDs was 0 for participants who used respiratory support for 28 days or longer or for participants who died on or before Day 28. A clinical status score of ≤ 4 on a given day was equivalent to an RFD. The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. A clinical status score of 4 was defined as a participant who was hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19).
Time frame: Randomization to Day 28
Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7
SaO2/FiO2 ratio was calculated as SaO2 divided by FiO2.
Time frame: Baseline and Day 7
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. The scale was as follows: * Score 1: Not hospitalized, no limitations on activities * Score 2: Not hospitalized, but with limitations on activities and/or requiring home oxygen * Score 3: Hospitalized, not requiring supplemental oxygen, and no longer requiring ongoing medical care * Score 4: Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19) * Score 5: Hospitalized, requiring supplemental oxygen * Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen devices * Score 7: Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation * Score 8: Death
Time frame: Days 7, 14, 21 and 28
Part 2: Number of Participants Alive and Respiratory Failure-free on Day 28
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Duarte, California, United States
Theravance Biopharma Investigational Site
Denver, Colorado, United States
Theravance Biopharma Investigational Site
Sebring, Florida, United States
Theravance Biopharma Investigational Site
Boston, Massachusetts, United States
Theravance Biopharma Investigational Site
Fall River, Massachusetts, United States
Theravance Biopharma Investigational Site
Kalispell, Montana, United States
Theravance Biopharma Investigational Site
Glens Falls, New York, United States
Theravance Biopharma
Hyde Park, New York, United States
Theravance Biopharma Investigational Site
Columbus, Ohio, United States
Theravance Biopharma Investigational Site
Allentown, Pennsylvania, United States
...and 14 more locations
Defined as participants who were alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) on Day 28.
Time frame: Day 28