Promising COVID-19 treatment trial pulled before it began

NCT ID NCT05137795

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 was designed to test whether an inhaled drug called ZYESAMI could help people with severe COVID-19 avoid getting worse and needing a ventilator. It was a Phase 3 trial, meaning it was in the final stage of testing. However, the study was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

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

Active substance
ZYESAMI (aviptadil acetate)
What this could lead to
If it had worked, this could have pointed toward a new inhaled treatment to prevent severe COVID-19 from getting worse.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no results are available. It is unclear if the treatment would have been safe or effective.

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.

Expected to start

Dec 2021

An estimate. Start dates often move.

Expected to finish

Aug 2022

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 85 years

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: 1. Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting ONE of the following: Respiratory rate ≥ 30 per minute Heart rate ≥ 125 per minute SpO2 ≤ 93% on room air at sea level PaO2/FiO2 \< 300 mmHg or SpO2/FiO2 \< 315 mmHg 2. Positive test by standard RT-PCR assay or equivalent within last 7 days 3. Physician determination that patient is on SOC therapy, and will receive standard of care if patient progresses to Critical COVID-19, patient must be full CODE Exclusion criteria: 1. Evidence of Critical COVID-19 2. Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications 3. Age \<12 years; 4. Mean arterial pressure \< 65 mm Hg after initial hospital stabilization, 5. Non-COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality; 6. Immunosuppressive treatment for transplant or other diseases associated with high mortality; 7. Stage IV cancer or cancer on active treatment with chemotherapy immunotherapy or checkpoint inhibitors; acute renal failure or chronic renal insufficiency with GFR less than 30; CHF New York Heart Association class III or IV, new neurologic disorder in the last 3 months or chronic neurologic disorder or other that would impact on assessing the resolution of severe COVID-19 respiratory failure 8. Myocardial Infarction in previous six months or troponin \>0.5 9. Recent history of venous thrombotic events (PE / DVT) within the last 3 months. 10. New diagnosis of atrial fibrillation within the last 3 months. Acceptable if greater than 3 months and well controlled in the opinion of the investigator 11. Watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes 12. Pregnancy

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lung injury/acute respiratory distress syndrome (ARDS) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.