Clinical trial NCT04551768: Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID19
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the clinical status severity (CSS) rating from the first dose date up to the completion of treatment
timeFrame: 7 days
Secondary outcomes:
measure: Time to recover gas exchange to a PaO2/FiO2 ≥300 for at least 24 hours.
timeFrame: 7 days
measure: Time to reach peripheral capillary oxygen saturation (Sp02) >94% for at least 24 hours.
timeFrame: 7 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Bausch Health Site 201
state: Attika
city: Athens
country: Greece
facility: Bausch Health Site 203
state: Attika
city: Alexandroupoli
country: Greece
facility: Bausch Health Site 204
state: Evros
city: Tijuana
country: Mexico
facility: Bausch Site 304
state: Zona Rio
Study officials:
affiliation: Bausch Health
name: Anya Loncaric
role: STUDY_DIRECTOR
References: