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COVID-19 drug trial pulled before it even started

NCT ID NCT04356677

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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 However, the trial was withdrawn before enrolling any volunteers, so no results were obtained.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The study was withdrawn before any participants were enrolled, so no results are available.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

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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