Trial · NCT06729606

Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

NCT06729606, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-10-09

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial). Trials, record NCT06729606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06729606

On this page

Trial

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

Title: Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
NCT number: NCT06729606
Status: Completed
Phases: Phase 3
Enrollment: 471 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Covid19
Interventions: Aviptadil, Aviptadil Placebo, Corticosteroid
First posted: 2024-12-11
Last updated: 2025-10-09
Results first posted: 2025-10-09

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Status on Day 90	The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.
Secondary	Number of Participants Who Died Through Day 90	Through Day 90
Secondary	Number of Participants With a Safety Outcome Through Day 5	Through Day 5	Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5
Secondary	Number of Participants With a Safety Outcome Through Day 28	Through Day 28	Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28
Secondary	Number of Participants Who Died Through Day 180	Through Day 180

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	Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Status on Day 90	6 participants in the Aviptadil+SOC arm and 5 participants in the Placebo+SOC arm did not have the day 90 status available to compute the primary endpoint. These participants were excluded from the analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Died Through Day 90	Through Day 90		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With a Safety Outcome Through Day 5	Through Day 5		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With a Safety Outcome Through Day 28	Through Day 28		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Died Through Day 180	Through Day 180		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Units
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Aviptadil + SOC	category 1 = at home and off oxygen (recovered) for at least 77 days	36	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Placebo + SOC	category 1 = at home and off oxygen (recovered) for at least 77 days	31	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Aviptadil + SOC	category 2 = at home and off oxygen for 49-76 days	37	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Placebo + SOC	category 2 = at home and off oxygen for 49-76 days	35	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Aviptadil + SOC	category 3 = at home and off oxygen for 1-48 days	43	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Placebo + SOC	category 3 = at home and off oxygen for 1-48 days	32	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Aviptadil + SOC	category 4 = not hospitalized but either on supplemental oxygen or not at home	15	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Placebo + SOC	category 4 = not hospitalized but either on supplemental oxygen or not at home	31	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Aviptadil + SOC	category 5 = hospitalized or in hospice care	8	Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90	Placebo + SOC	category 5 = hospitalized or in hospice care	13	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Aviptadil + SOC	234
Overall Study	STARTED	Placebo + SOC	237
Overall Study	COMPLETED	Aviptadil + SOC	231
Overall Study	COMPLETED	Placebo + SOC	230
Overall Study	NOT COMPLETED	Aviptadil + SOC	3
Overall Study	NOT COMPLETED	Placebo + SOC	7

Source ClinicalTrials.gov

Adverse events484

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 + SOC	6	231	6
other	Anaemia	Blood and lymphatic system disorders	Placebo + SOC	4	230	4
other	Blood loss anaemia	Blood and lymphatic system disorders	Aviptadil + SOC	1	231	1
other	Blood loss anaemia	Blood and lymphatic system disorders	Placebo + SOC	2	230	2
other	Coagulopathy	Blood and lymphatic system disorders	Aviptadil + SOC	1	231	1
other	Coagulopathy	Blood and lymphatic system disorders	Placebo + SOC	0	230	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Aviptadil + SOC	0	231	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Placebo + SOC	2	230	2
other	Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Aviptadil + SOC	0	231	0
other	Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Placebo + SOC	1	230	1

1 to 10 of 484Source ClinicalTrials.gov

See all 484 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aviptadil + SOC	90	231
Total, all-cause mortality	Placebo + SOC	86	230
Total, other adverse events	Aviptadil + SOC	200	231
Total, other adverse events	Placebo + SOC	176	230
Total, serious adverse events	Aviptadil + SOC	25	231
Total, serious adverse events	Placebo + SOC	23	230

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 comparisons6

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

Comparison	Source
Aviptadil + SOC vs Placebo + SOC: Number of Participants With a Safety Outcome Through Day 28	Trial comparisons
Aviptadil + SOC vs Placebo + SOC: Number of Participants Who Died Through Day 180	Trial comparisons
Aviptadil + SOC vs Placebo + SOC: deaths from any cause	Trial comparisons
Aviptadil + SOC vs Placebo + SOC: Number of Participants With a Safety Outcome Through Day 5	Trial comparisons
Aviptadil + SOC vs Placebo + SOC: Number of Participants Who Died Through Day 90	Trial comparisons
Aviptadil + SOC vs Placebo + SOC: 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/NCT06729606

GET https://conductscience.org/api/trials/v1/NCT06729606/events?page=2

API reference For AI assistants