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NCT04402866 · ClinicalTrials.gov registry record · Phase 2
TD-0903 for ALI Associated With COVID-19
A Phase 2 study of Acute Lung Injury (ALI) Associated With COVID-19 and Lung Inflammation Associated With COVID-19, sponsored by Theravance Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 235
- Enrollment target
- 20
- Study locations
NCT04402866: Completed Phase 2 study of Acute Lung Injury (ALI) Associated With COVID-19 and Lung Inflammation Associated With COVID-19, sponsored by Theravance Biopharma.
NCT04402866 is a Phase 2 study of Acute Lung Injury (ALI) Associated With COVID-19 and Lung Inflammation Associated With COVID-19 that has completed, run by Theravance Biopharma. The registered enrollment target is 235 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04402866, a Phase 2 study of Acute Lung Injury (ALI) Associated With COVID-19 and Lung Inflammation Associated With COVID-19, has completed, sponsored by Theravance Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 235 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 cl
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TD-0903
Study Locations (20)
Other
- Theravance Biopharma Investigational Site - Bela Vista
- Theravance Biopharma Investigational Site - Botucatu
- Theravance Biopharma Investigational Site - Caxias do Sul
- Theravance Biopharma Investigational Site - São José do Rio Preto
- Theravance Biopharma Investigational Site - Helsinki
- Theravance Biopharma Investigational Site - Turku
- Theravance Biopharma Investigational Site - Chisinau
- Theravance Biopharma Investigational Site - Bucharest
Massachusetts
- Theravance Biopharma Investigational Site - Boston
- Theravance Biopharma Investigational Site - Fall River
New York
- Theravance Biopharma Investigational Site - Glens Falls
- Theravance Biopharma - Hyde Park
Pennsylvania
- Theravance Biopharma Investigational Site - Allentown
- Theravance Biopharma Investigational Site - Bethlehem
California
- Theravance Biopharma Investigational Site - Duarte
Colorado
- Theravance Biopharma Investigational Site - Denver
Florida
- Theravance Biopharma Investigational Site - Sebring
Montana
- Theravance Biopharma Investigational Site - Kalispell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2021-04-21 |
| Phase | Phase 2 |
What the finished NCT04402866 record still lists
NCT04402866 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher).
The record links to 2 conditions, with Acute Lung Injury (ALI) Associated With COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04402866 names 20 study sites across 10 states, led by Other, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04402866 about?
NCT04402866 is a clinical study titled "TD-0903 for ALI Associated With COVID-19". 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.
What is the current status of trial NCT04402866?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 235 participants. The study started on 2020-06-24. Estimated completion is 2021-04-21.
What conditions does trial NCT04402866 study?
This clinical trial studies the following conditions: Acute Lung Injury (ALI) Associated With COVID-19, Lung Inflammation Associated With COVID-19.
What interventions are being tested in trial NCT04402866?
The interventions under investigation include: Placebo (DRUG), TD-0903 (DRUG).
Who is sponsoring clinical trial NCT04402866?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04402866 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04402866's enrollment target sits among peer trials
235 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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