Promising COVID-19 treatment trial pulled before it began
NCT ID NCT05137795
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 However, the study was withdrawn before any participants were enrolled, so no data was collected.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- The trial was withdrawn before any participants were enrolled, so no results are available.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 Hide 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
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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.
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