COVID19Phase 1NCT04551768
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
A Phase 1 study testing 50 mg/mL Virazole and 100 mg/mL Virazole in people with COVID19, run by Bausch Health Americas, Inc. at 4 sites in 2 countries.
Trial summary
This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio <300 mmHg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- 50 mg/mL Virazole and 100 mg/mL Virazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Feb 2021to 17 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female ≥ 18 years of age.
- Willing and able to provide written informed consent (or provided by a proxy).
- Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
- PaO2/FiO2 ratio <300 mmHg.
- Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
Show all 9Show fewer
- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR
- Requiring mechanical ventilation and/or supplemental oxygen.
- Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months.
Who cannot join
- Pregnant or breast feeding.
- Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
- Presence of secondary bacterial pneumonia.
- Presence of significant pulmonary fibrosis.
- Hypotension (need for hemodynamic pressors to maintain blood pressure).
- Greater than 7 days on mechanical ventilation.
Show all 12Show fewer
- Anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for race, age and gender.
- History of COPD or bronchospasm prior to COVID-19 infection.
- History of hypersensitivity to ribavirin.
- Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
- Subject is currently participating in any drug or device clinical investigation.
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Greece3 sites
Bausch Health Site 204
Alexandroupoli, Evros, 68100
Bausch Health Site 201
Athens, Attica, 10676
Bausch Health Site 203
Athens, Attica, 11527
About this study
Official title: An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio <300 mmHg).
- Conditions
- COVID19
- Being tested
- 50 mg/mL Virazole, 100 mg/mL Virazole
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg/mL VirazoleDrug
50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
100 mg/mL VirazoleDrug
100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
| Study group | Role | What they receive |
|---|---|---|
| 50 mg/mL Virazole | Experimental | 50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. Receives: Drug: 50 mg/mL Virazole |
| 100 mg/mL Virazole | Experimental | 100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. Receives: Drug: 100 mg/mL Virazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
The severity rating will be based on the ordinal scale of clinical status as follows:
- Death.
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Hospitalized, on non-invasive ventilation or high flow oxygen devices.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, not requiring supplemental oxygen.
- Not hospitalized, limitation on activities.
- Not hospitalized, no limitations on activities.
Measured: 7 days
Secondary outcomes (2)
Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
Measured: 7 days
Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start10 Feb 2021
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551768
- Sponsor's protocol ID
- BHC-RIB-5401-GL
- Status last verified
- Aug 2021
- First submitted
- 15 Sep 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
- ClinicalTrials.gov ID
- NCT04551768
- Acronym / sponsor ID
- BHC-RIB-5401-GL
- Conditions
- COVID19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio <300 mmHg).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 mg/mL Virazole | Experimental | Drug: 50 mg/mL Virazole50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. |
| 100 mg/mL Virazole | Experimental | Drug: 100 mg/mL Virazole100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant female ≥ 18 years of age.
- Willing and able to provide written informed consent (or provided by a proxy).
- Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
- PaO2/FiO2 ratio <300 mmHg.
- Illness of any duration, and at least one of the following:
Key exclusion criteria (12 listed)
- Pregnant or breast feeding.
- Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
- Presence of secondary bacterial pneumonia.
- Presence of significant pulmonary fibrosis.
- Hypotension (need for hemodynamic pressors to maintain blood pressure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg/mL Virazole50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days. | Drug | 50 mg/mL Virazole |
| 100 mg/mL Virazole100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days. | Drug | 100 mg/mL Virazole |
Primary outcome
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
Time frame: 7 days
The severity rating will be based on the ordinal scale of clinical status as follows: 1. Death. 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, not requiring supplemental oxygen. 6. Not hospitalized, limitation on activities. 7. Not hospitalized, no limitations on activities.
2 secondary outcomes
Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
Time frame: 7 days
Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for COVID19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anya Loncaric study director
Bausch Health Americas, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 mg/mL Virazole and 100 mg/mL Virazole in people with COVID19, run by Bausch Health Americas, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.