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New hope for COVID-19 patients on ventilators: drug combo trial completed

NCT ID NCT04843761

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested two drugs—remdesivir and aviptadil—in hospitalized COVID-19 patients with severe breathing failure. About 473 participants received either a study drug plus standard care or a placebo plus standard care. The goal was to see if these drugs could safely improve outcomes for the sickest patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remdesivir and Aviptadil (vasoactive intestinal peptide)
What this could lead to
If successful, these drugs could provide effective treatments for severe COVID-19 respiratory failure, potentially reducing deaths and speeding recovery.
What could go wrong
This is a completed Phase 3 trial, but results may not show clear benefit over standard care. Side effects from the drugs or placebo effects could complicate findings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

473 people

The number who actually took part.

Started

Apr 2021

Finished

Nov 2022

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent. * Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19 (not for purely public health or quarantine purposes). * Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO used to treat acute hypoxemic respiratory failure). * SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization. * Respiratory failure is believed to be due to SARS-CoV-2 pneumonia. Exclusion Criteria: * Known allergy to investigational agent or vehicle. * More than 4 days since initiation of support for respiratory failure. * Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion). * Moribund patient (i.e. not expected to survive 24 hours). * Active use of "comfort care" or other hospice-equivalent SOC. * Expected inability to participate in study procedures. * In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments. * Previous enrollment in TESICO Additional agent-specific criteria also apply, and are listed in the substudy records Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606) Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease Coronaviridae Infections COVID-19 Nidovirales infectious disease RNA Virus Infections severe acute respiratory syndrome viral infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID19

Contacts and locations

Locations

  • Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue

    Tucson, Arizona, 85719, United States

  • Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.

    Dallas, Texas, 75246, United States

  • Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street

    Springfield, Massachusetts, 01199, United States

  • Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Ave.

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road

    Mayfield Heights, Ohio, 44124, United States

  • Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road

    Garfield Heights, Ohio, 44125, United States

  • Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.

    New York, New York, 10032, United States

  • Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B

    Denver, Colorado, 80204, United States

  • Duke University Hospital (Site 301-006), 2301 Erwin Road

    Durham, North Carolina, 27710, United States

  • Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.

    Atlanta, Georgia, 30322, United States

  • Harborview Medical Center (Site 208-001), 325 9th Ave.

    Seattle, Washington, 98104, United States

  • Houston Methodist Hospital (Site 301-028), 6565 Fannin Street

    Houston, Texas, 77030, United States

  • Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street

    Murray, Utah, 84107, United States

  • Massachusetts General Hospital (Site 202-002), 55 Fruit Street

    Boston, Massachusetts, 02114, United States

  • MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214

    Charleston, South Carolina, 29425, United States

  • Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street

    The Bronx, New York, 10467, 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, 10029, United States

  • Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.

    Portland, Oregon, 97239-3098, United States

  • Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza

    Los Angeles, California, 90095, United States

  • Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.

    Stanford, California, 94305, United States

  • Swedish Medical Center (Site 208-005), 747 Broadway

    Seattle, Washington, 98122, United States

  • Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266

    Houston, Texas, 77030, United States

  • The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue

    Columbus, Ohio, 43210, United States

  • UCSF Fresno (Site 203-005), 155 N. Fresno Street

    Fresno, California, 93701, United States

  • UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.

    San Francisco, California, 94143, United States

  • UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.

    San Francisco, California, 94115, United States

  • UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.

    Charlottesville, Virginia, 22908, United States

  • University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue

    Aurora, Colorado, 80045, United States

  • University of Texas Health Science Center (Site 203-006), 7000 Fannin St.

    Houston, Texas, 77030, United States

  • University of Utah Hospital (Site 211-002), 50 North Medical Drive

    Salt Lake City, Utah, 84132, United States

  • VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street

    Loma Linda, California, 92357, United States

  • Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Health (Site 210-001), Medical Center Blvd

    Winston-Salem, North Carolina, 27157, United States

  • Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.

    Washington D.C., District of Columbia, 20422, United States

  • West Virginia University Medicine (Site 301-023), One Medical Center Drive

    Morgantown, West Virginia, 26506, United States

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