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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 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. The trial reports 20 study locations across 10 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04402866
The ClinicalTrials.gov registry entry for NCT04402866 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravance Biopharma, which has 38 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Acute Lung Injury (ALI) Associated With COVID-19
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Lung Inflammation Associated With COVID-19
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California
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