Trial · NCT04478071

Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

NCT04478071, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2025-03-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19). Trials, record NCT04478071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04478071

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Trial

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

Title: Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
NCT number: NCT04478071
Status: Completed
Phases: Phase 2
Enrollment: 448 participants, actual
Lead sponsor: The University of Texas Health Science Center, Houston
Conditions: Acute Respiratory Distress Syndrome, Coronavirus Infection
Interventions: vadadustat, placebo
First posted: 2020-07-20
Last updated: 2025-03-26
Results first posted: 2025-03-26

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale	day 14	National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities
Secondary	Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 14	Modified Sequential Organ Failure Assessment (MSOFA) scale: Each of 5 organ systems is given a score of 0 to 4.The MSOFA scale total score is the sum of the score for the 5 organ systems. Total score ranges from 0 to 20, a higher score indicates a worse outcome. Discharged patients will be assigned a score of 0 and dead patients a score of 20.
Other	Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 7	Modified Sequential Organ Failure Assessment (MSOFA) scale: Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. * Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (\> 400); 1 (≤ 400); 2 (≤ 315); 3 (≤ 235); 4 (≤ 150) * Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) * Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP \< 70 mm Hg); 2 (Dopamine ≤ 5 or dobutamine any dose); 3 (Dopamine \> 5, Epinephrine ≤ 0.1, Norepinephrine ≤ 0.1); 4 (Dopamine \> 15, Epinephrine \> 0.1, Norepinephrine \> 0.1) * Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (\< 6) * Renal, Creatinine mg/dL: 0 (\< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (\> 5.0)
Other	Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 14	Modified Sequential Organ Failure Assessment (MSOFA) scale: Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. * Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (\> 400); 1 (≤ 400); 2 (≤ 315); 3 (≤ 235); 4 (≤ 150) * Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) * Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP \< 70 mm Hg); 2 (Dopamine ≤ 5 or dobutamine any dose); 3 (Dopamine \> 5, Epinephrine ≤ 0.1, Norepinephrine ≤ 0.1); 4 (Dopamine \> 15, Epinephrine \> 0.1, Norepinephrine \> 0.1) * Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (\< 6) * Renal, Creatinine mg/dL: 0 (\< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (\> 5.0)
Other	Ventilator-free Survival	day 7
Other	Ventilator-free Survival	day 14
Other	Overall Survival	day 7
Other	Overall Survival	day 14
Other	Number of Participants With Hypotension	day 7	Hypotension is defined as Mean Arterial Pressure (MAP) \<70 mm Hg or requirement for inotropes or vasopressors to maintain blood pressure.
Other	Number of Participants With Hypotension	day 14	Hypotension is defined as Mean Arterial Pressure (MAP) \<70 mm Hg or requirement for inotropes or vasopressors to maintain blood pressure.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale	day 14		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 14	Data were not collected for 2 participants in the vadadustat arm.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 7
OTHER_PRE_SPECIFIED	Score on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	day 14
OTHER_PRE_SPECIFIED	Ventilator-free Survival	day 7
OTHER_PRE_SPECIFIED	Ventilator-free Survival	day 14
OTHER_PRE_SPECIFIED	Overall Survival	day 7
OTHER_PRE_SPECIFIED	Overall Survival	day 14
OTHER_PRE_SPECIFIED	Number of Participants With Hypotension	day 7
OTHER_PRE_SPECIFIED	Number of Participants With Hypotension	day 14

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group4

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

Outcome	Group	Value	Units
Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale	Vadadustat	43	Participants
Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale	Placebo	53	Participants
Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	Vadadustat	156	Participants
Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	Placebo	157	Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vadadustat	221
Overall Study	STARTED	Placebo	227
Overall Study	Completed Day 7	Vadadustat	217
Overall Study	Completed Day 7	Placebo	223
Overall Study	Completed Day 14	Vadadustat	216
Overall Study	Completed Day 14	Placebo	223
Overall Study	Completed Day 28	Vadadustat	215
Overall Study	Completed Day 28	Placebo	221
Overall Study	COMPLETED	Vadadustat	215
Overall Study	COMPLETED	Placebo	221

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events98

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	Events
other	Alanine aminotransferase increased	Investigations	Vadadustat	69	221	70
other	Alanine aminotransferase increased	Investigations	Placebo	51	227	51
other	Anemia	Blood and lymphatic system disorders	Vadadustat	30	221	30
other	Anemia	Blood and lymphatic system disorders	Placebo	38	227	39
other	Aspartate aminotransferase increased	Investigations	Vadadustat	30	221	30
other	Aspartate aminotransferase increased	Investigations	Placebo	32	227	33
other	Hyperkalemia	Metabolism and nutrition disorders	Vadadustat	24	221	27
other	Hyperkalemia	Metabolism and nutrition disorders	Placebo	21	227	21
other	Hypermagnesemia	Metabolism and nutrition disorders	Vadadustat	17	221	17
other	Hypermagnesemia	Metabolism and nutrition disorders	Placebo	33	227	34

1 to 10 of 98Source ClinicalTrials.gov

See all 98 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vadadustat	19	221
Total, all-cause mortality	Placebo	19	227
Total, other adverse events	Vadadustat	109	221
Total, other adverse events	Placebo	116	227
Total, serious adverse events	Vadadustat	61	221
Total, serious adverse events	Placebo	73	227

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons4

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

Comparison	Source
Vadadustat vs Placebo: Number of Participants With a Total Score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) Scale	Trial comparisons
Vadadustat vs Placebo: Number of Participants Who Are Classified 8 (Dead), 7 (Hospitalized, on Invasive Mechanical Ventilation or ECMO), or 6 (Hospitalized, on Non-invasive Ventilation or High Flow Oxygen Devices) on the NIAID Ordinal Scale	Trial comparisons
Vadadustat vs Placebo: deaths from any cause	Trial comparisons
Vadadustat vs Placebo: serious adverse events	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/NCT04478071

GET https://conductscience.org/api/trials/v1/NCT04478071/events?page=2

API reference For AI assistants