Trial · NCT04311697

Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

NCT04311697, Phase 2, Phase 3, Completed, APR Applied Pharma Research s.a.; results first posted 2023-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure. Trials, record NCT04311697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04311697

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Trial

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

Title: Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
NCT number: NCT04311697
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 203 participants, actual
Lead sponsor: APR Applied Pharma Research s.a.
Conditions: Critical COVID-19 With Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Corona Virus Infection, Acute Lung Injury
Interventions: Aviptadil by intravenous infusion + standard of care, Normal Saline Infusion + standard of care
First posted: 2020-03-17
Last updated: 2023-07-24
Results first posted: 2023-07-24

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)	Day 28	Participant is Alive and Free of Respiratory Failure (without subsequent relapse over 7 days) determined as no longer requiring acute care or more than low flow oxygen
Secondary	Number of Participants Alive at Day 60	Day 60	Survival probability on logistic regression through day 60
Secondary	Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60	Day 60	Achievement of score 6-8 on NIAID Ordinal Scale through day 60 The NIAID score is the patient's status on the following 8-point scale:1)Death2)Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO),3)Hospitalized, on non-invasive ventilation or high flow oxygen devices4)Hospitalized, requiring supplemental oxygen5)Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)6)Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care7)Not hospitalized, limitation on activities and/or requiring home oxygen8)Not hospitalized, no limitations on activities-- a lower NIAID score is a worse outcome.
Secondary	Oxygenation Index as Measured by PaO2:FiO2 Ratio	Day 7	oxygenation index (also known as Respiratory Distress Ratio) as measured by PaO2:FiO2 ratio (Respiratory Distress while on mechanical ventilation). RDR: PaO2:FiO2 represents an intermediate clinical endpoint that is known to be predictive of survival. RDR can only be measured in patients on mechanical ventilation because of its reliance on arterial blood gas measurements that are not routinely collected in non-intubated patients. A higher score indicates a better clinical outcome.
Other	Change in IL-6	Day 28	Change in IL-6, an inflammatory marker

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)	Day 28		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Alive at Day 60	Day 60		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60	Day 60		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Oxygenation Index as Measured by PaO2:FiO2 Ratio	Day 7	only patients with observations were analyzed	PaO2:FiO2 ratio	MEAN
OTHER_PRE_SPECIFIED	Change in IL-6	Day 28		IL-6 picogram/mL	MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)	Aviptadil IV in Escalating Doses + Standard of Care	72		Participants
Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)	Placebo + Standard of Care	33		Participants
Number of Participants Alive at Day 60	Aviptadil IV in Escalating Doses + Standard of Care	85		Participants
Number of Participants Alive at Day 60	Placebo + Standard of Care	35		Participants
Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60	Aviptadil IV in Escalating Doses + Standard of Care	76		Participants
Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60	Placebo + Standard of Care	35		Participants
Oxygenation Index as Measured by PaO2:FiO2 Ratio	Aviptadil IV in Escalating Doses + Standard of Care	139.2	Standard Deviation 77.0	PaO2:FiO2 ratio
Oxygenation Index as Measured by PaO2:FiO2 Ratio	Placebo + Standard of Care	116.2	Standard Deviation 41.77	PaO2:FiO2 ratio
Change in IL-6	Aviptadil IV in Escalating Doses + Standard of Care	19.8	Standard Deviation 39.9	IL-6 picogram/mL
Change in IL-6	Placebo + Standard of Care	23.5	Standard Deviation 39.7	IL-6 picogram/mL

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Aviptadil IV in Escalating Doses + Standard of Care	136
Overall Study	STARTED	Placebo + Standard of Care	67
Overall Study	COMPLETED	Aviptadil IV in Escalating Doses + Standard of Care	85
Overall Study	COMPLETED	Placebo + Standard of Care	35
Overall Study	NOT COMPLETED	Aviptadil IV in Escalating Doses + Standard of Care	51
Overall Study	NOT COMPLETED	Placebo + Standard of Care	32

Source ClinicalTrials.gov

Adverse events284

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	anaemia	Blood and lymphatic system disorders	Aviptadil IV in Escalating Doses + Standard of Care	8	131	8
other	anaemia	Blood and lymphatic system disorders	Placebo + Standard of Care	4	65	4
other	leukocytosis	Blood and lymphatic system disorders	Aviptadil IV in Escalating Doses + Standard of Care	8	131	8
other	leukocytosis	Blood and lymphatic system disorders	Placebo + Standard of Care	5	65	5
other	thrombocytopenia	Blood and lymphatic system disorders	Aviptadil IV in Escalating Doses + Standard of Care	2	131	2
other	thrombocytopenia	Blood and lymphatic system disorders	Placebo + Standard of Care	5	65	5
other	atrial fibrillation	Cardiac disorders	Aviptadil IV in Escalating Doses + Standard of Care	15	131	18
other	atrial fibrillation	Cardiac disorders	Placebo + Standard of Care	3	65	3
other	bradycardia	Cardiac disorders	Aviptadil IV in Escalating Doses + Standard of Care	9	131	9
other	bradycardia	Cardiac disorders	Placebo + Standard of Care	3	65	4

1 to 10 of 284Source ClinicalTrials.gov

See all 284 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aviptadil IV in Escalating Doses + Standard of Care	46	131
Total, all-cause mortality	Placebo + Standard of Care	30	65
Total, other adverse events	Aviptadil IV in Escalating Doses + Standard of Care	102	131
Total, other adverse events	Placebo + Standard of Care	49	65
Total, serious adverse events	Aviptadil IV in Escalating Doses + Standard of Care	58	131
Total, serious adverse events	Placebo + Standard of Care	32	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36044317	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 comparisons5

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

Comparison	Source
Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60	Trial comparisons
Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)	Trial comparisons
Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: Number of Participants Alive at Day 60	Trial comparisons
Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: deaths from any cause	Trial comparisons
Aviptadil IV in Escalating Doses + Standard of Care vs Placebo + Standard of Care: 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/NCT04311697

GET https://conductscience.org/api/trials/v1/NCT04311697/events?page=2

API reference For AI assistants