COVID-19 drug trial pulled before it even started
NCT ID NCT04356677
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study planned to test an inhaled medicine called Virazole (ribavirin) in adults hospitalized with COVID-19 who had serious breathing trouble. The goal was to see if the drug was safe and could improve oxygen levels. However, the trial was withdrawn before enrolling any volunteers, so no results were obtained.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Virazole (ribavirin) given as an inhaled mist
- What this could lead to
- If it worked, this could point toward a treatment for severe COVID-19 breathing distress.
- What could go wrong
- The study was withdrawn before any participants were enrolled, so no results are available. Ribavirin has known side effects and may not be effective against COVID-19.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
-
May 2021
An estimate. Start dates often move.
- Expected to finish
-
Aug 2021
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 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. Male or non-pregnant female ≥ 18 years of age. 2. Willing and able to provide written informed consent (or provided by a proxy). 3. Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection. 4. PaO2/FiO2 ratio \<300 mmHg. 5. Illness of any duration, and at least one of the following: * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR * Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR * Requiring mechanical ventilation and/or supplemental oxygen. 6. Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months. Exclusion Criteria: 1. Pregnant or breast feeding. 2. Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.). 3. Presence of secondary bacterial pneumonia. 4. Presence of significant pulmonary fibrosis. 5. Hypotension (need for hemodynamic pressors to maintain blood pressure). 6. Greater than 7 days on mechanical ventilation. 7. Anemia defined as hemoglobin or RBC \<75% of the institutional lower limit of normal for race, age and gender. 8. History of COPD or bronchospasm prior to COVID-19 infection. 9. History of hypersensitivity to ribavirin. 10. Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study 11. Subject is currently participating in any drug or device clinical investigation. 12. Subject has received an investigational agent or approved drug that, in the Investigator's judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit.
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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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