Trial · NCT04402866

TD-0903 for ALI Associated With COVID-19

NCT04402866, Phase 2, Completed, Theravance Biopharma; results first posted 2022-03-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. TD-0903 for ALI Associated With COVID-19. Trials, record NCT04402866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04402866

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: TD-0903 for ALI Associated With COVID-19
NCT number: NCT04402866
Status: Completed
Phases: Phase 2
Enrollment: 235 participants, actual
Lead sponsor: Theravance Biopharma
Conditions: Acute Lung Injury (ALI) Associated With COVID-19, Lung Inflammation Associated With COVID-19
Interventions: TD-0903, Placebo
First posted: 2020-05-27
Last updated: 2022-03-17
Other registries' IDs: eudract:2020-001807-18
Results first posted: 2022-03-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28	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).
Secondary	Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7	Baseline and Day 7	SaO2/FiO2 ratio was calculated as SaO2 divided by FiO2.
Secondary	Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	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
Secondary	Part 2: Number of Participants Alive and Respiratory Failure-free on Day 28	Day 28	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28	Randomization to Day 28	ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.	days	MEDIAN
SECONDARY	Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7	Baseline and Day 7	ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.	ratio measure	LEAST_SQUARES_MEAN
SECONDARY	Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Days 7, 14, 21 and 28	ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Part 2: Number of Participants Alive and Respiratory Failure-free on Day 28	Day 28	ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28	Part 2: Matching Placebo		21.0	Inter-Quartile Range 15.0 to 23.0	days
Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28	Part 2: TD-0903 - 3 mg		21.0	Inter-Quartile Range 17.5 to 23.0	days
Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7	Part 2: Matching Placebo		88.97	Standard Error 7.769	ratio measure
Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7	Part 2: TD-0903 - 3 mg		88.46	Standard Error 7.654	ratio measure
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Part 2: Matching Placebo	Day 7 / Score 1	6		Participants
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Part 2: TD-0903 - 3 mg	Day 7 / Score 1	8		Participants
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Part 2: Matching Placebo	Day 7 / Score 2	12		Participants
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Part 2: TD-0903 - 3 mg	Day 7 / Score 2	9		Participants
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Part 2: Matching Placebo	Day 7 / Score 3	1		Participants
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28	Part 2: TD-0903 - 3 mg	Day 7 / Score 3	1		Participants

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Part 1: Matching Placebo	6
Overall Study	STARTED	Part 1: TD-0903 - 1 mg	6
Overall Study	STARTED	Part 1: TD-0903 - 3 mg	7
Overall Study	STARTED	Part 1: TD-0903 - 10 mg	6
Overall Study	STARTED	Part 2: Matching Placebo	104
Overall Study	STARTED	Part 2: TD-0903 - 3 mg	106
Overall Study	Randomized and Treated With Study Drug	Part 1: Matching Placebo	6
Overall Study	Randomized and Treated With Study Drug	Part 1: TD-0903 - 1 mg	6
Overall Study	Randomized and Treated With Study Drug	Part 1: TD-0903 - 3 mg	7
Overall Study	Randomized and Treated With Study Drug	Part 1: TD-0903 - 10 mg	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events288

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cough	Respiratory, thoracic and mediastinal disorders	Part 1: Matching Placebo	0	6
other	Cough	Respiratory, thoracic and mediastinal disorders	Part 1: TD-0903 - 1 mg	0	6
other	Cough	Respiratory, thoracic and mediastinal disorders	Part 1: TD-0903 - 3 mg	0	7
other	Cough	Respiratory, thoracic and mediastinal disorders	Part 1: TD-0903 - 10 mg	3	6
other	Cough	Respiratory, thoracic and mediastinal disorders	Part 2: Matching Placebo	1	102
other	Cough	Respiratory, thoracic and mediastinal disorders	Part 2: TD-0903 - 3 mg	3	103
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Part 1: Matching Placebo	0	6
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Part 1: TD-0903 - 1 mg	1	6
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Part 1: TD-0903 - 3 mg	0	7
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Part 1: TD-0903 - 10 mg	1	6

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: Matching Placebo	2	6
Total, all-cause mortality	Part 1: TD-0903 - 1 mg	1	6
Total, all-cause mortality	Part 1: TD-0903 - 3 mg	0	7
Total, all-cause mortality	Part 1: TD-0903 - 10 mg	0	6
Total, all-cause mortality	Part 2: Matching Placebo	13	102
Total, all-cause mortality	Part 2: TD-0903 - 3 mg	6	103
Total, other adverse events	Part 1: Matching Placebo	6	6
Total, other adverse events	Part 1: TD-0903 - 1 mg	4	6
Total, other adverse events	Part 1: TD-0903 - 3 mg	1	7
Total, other adverse events	Part 1: TD-0903 - 10 mg	5	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37460276	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Part 2: TD-0903 - 3 mg vs Part 2: Matching Placebo: Part 2: Number of Participants Alive and Respiratory Failure-free on Day 28

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04402866

GET https://conductscience.org/api/trials/v1/NCT04402866/results?page=2

API reference For AI assistants