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

Phase 3

Completed

• Conditions: Covid19
• Interventions: Biological: Aviptidil; Biological: Aviptidil Placebo; Drug: Corticosteroid

• Registration Number: NCT06729606
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

This study looks at the safety and effectiveness of Aviptidil 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 Aviptidil plus current standard of care (SOC), or with placebo plus current SOC.

Detailed Description

This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Aviptidil 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 Aviptidil 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2022-08-22
• Study Completion: 2022-11-20
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

Refer to the master protocol (NCT04843761)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aviptidil + SOC	Aviptidil	-
Aviptidil + SOC	Corticosteroid	-
Placebo + SOC	Aviptidil Placebo	-
Placebo + SOC	Corticosteroid	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants Who Died Through Day 90	Through Day 90	Time to death through Day 90
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
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
Number of Participants Who Died Through Day 180	Through Day 180	Time to death through Day 180

Trial Locations

Locations (40)

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, District of Columbia, United States

Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.; 🇺🇸 Washington, District of Columbia, United States

Massachusetts General Hospital (Site 202-002), 55 Fruit Street; 🇺🇸 Boston, Massachusetts, United States

Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.; 🇺🇸 Atlanta, Georgia, United States

Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street; 🇺🇸 Springfield, Massachusetts, United States

Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street; 🇺🇸 Bronx, New York, 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

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

The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue; 🇺🇸 Columbus, Ohio, United States

Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road; 🇺🇸 Garfield Heights, Ohio, United States

Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road; 🇺🇸 Mayfield Heights, Ohio, United States

Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.; 🇺🇸 Portland, Oregon, United States

Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive; 🇺🇸 Nashville, Tennessee, United States

Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.; 🇺🇸 Dallas, Texas, United States

Houston Methodist Hospital (Site 301-028), 6565 Fannin Street; 🇺🇸 Houston, Texas, United States

Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266; 🇺🇸 Houston, Texas, United States

University of Texas Health Science Center (Site 203-006), 7000 Fannin St.; 🇺🇸 Houston, Texas, United States

Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street; 🇺🇸 Murray, Utah, United States

University of Utah Hospital (Site 211-002), 50 North Medical Drive; 🇺🇸 Salt Lake City, Utah, United States

UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.; 🇺🇸 Charlottesville, Virginia, United States

Harborview Medical Center (Site 208-001), 325 9th Ave.; 🇺🇸 Seattle, Washington, United States

Swedish Medical Center (Site 208-005), 747 Broadway; 🇺🇸 Seattle, Washington, United States

West Virginia University Medicine (Site 301-023), One Medical Center Drive; 🇺🇸 Morgantown, West Virginia, United States