BIOLOGICAL
Aviptadil
Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr.
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
Status
Completed
Phase
Phase 3
Enrollment
471
Locations
40
Results
Posted
Publications
0
Study summary
What the protocol is testing.
This study looks at the safety and effectiveness of Aviptadil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.
Full detailed description
This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Aviptadil at improving outcomes for patients with acute respiratory failure related to COVID-19. This protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol. This protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs. The protocol is for a Phase 3 study. Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days. This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for Aviptadil versus placebo with use of the ordinal outcome. The planned sample size is 320 participants. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio. Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) at enrollment. Other agent-specific stratification factors may be considered. An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.
Interventions
Treatment arms and agents.
BIOLOGICAL
Aviptadil Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.
DRUG
Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Timeline
From registration to results.
First posted
Dec 11, 2024
Study start
Apr 20, 2021
Primary completion
Aug 22, 2022
Study completion
Nov 20, 2022
Results posted
Oct 9, 2025
Registry updated
Oct 9, 2025
Outcomes
What the study measures.
Primary outcomes
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90
Time frame · 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 outcomes
Number of Participants Who Died Through Day 90
Time frame · Through Day 90
Number of Participants With a Safety Outcome Through Day 5
Time frame · 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
Number of Participants With a Safety Outcome Through Day 28
Time frame · 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
Number of Participants Who Died Through Day 180
Time frame · Through Day 180
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: Refer to the master protocol (NCT04843761) Exclusion Criteria: Refer to the master protocol (NCT04843761) Additional Exclusion Criteria: * Refractory hypotension * Severe diarrhea * Current C. difficile infection * Pregnancy or current breast-feeding * End-stage liver disease
Study locations
40 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
Tucson, Arizona, United States
UCSF Fresno (Site 203-005), 155 N. Fresno Street
Fresno, California, United States
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
Loma Linda, California, United States
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
Los Angeles, California, United States
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
San Francisco, California, United States
UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.
San Francisco, California, United States
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
Stanford, California, United States
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
Aurora, Colorado, United States
Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B
Denver, Colorado, United States
MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
Washington D.C., District of Columbia, United States
Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.
Atlanta, Georgia, United States
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
Boston, Massachusetts, United States
Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street
Springfield, Massachusetts, United States
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place
New York, New York, United States
Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.
New York, New York, United States
Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street
The Bronx, New York, United States
Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street
The Bronx, New York, United States
Duke University Hospital (Site 301-006), 2301 Erwin Road
Durham, North Carolina, United States
Wake Forest Baptist Health (Site 210-001), Medical Center Blvd
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740
Cincinnati, Ohio, United States
Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Ave.
Cleveland, Ohio, United States
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.
Cleveland, Ohio, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Aviptadil.
NCT IDStudyPhase / statusEnrollmentUpdated
Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19
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Phase 3
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Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
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2024-01
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
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2023-07
A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
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Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
APR Applied Pharma Research s.a. · SARS-CoV 2 · COVID
Phase 2 / Phase 3
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2023-02
ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)
APR Applied Pharma Research s.a. · Critical COVID-19 With Respiratory Failure
Not applicable
No Longer Available
—
2023-02
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Put the record in context.
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