Phase IV Study to Evaluate Safety of Favipiravir Treatment in Patients with COVID-19 Disease.
- Conditions
- Health Condition 1: U071- COVID 19 virus identified
- Registration Number
- CTRI/2022/07/043994
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 196
1. Adults with confirmed COVID 19 infection.
2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
4. Male or non-pregnant female adult 18 to 65 years of age at time of enrollment.
5. Duration of symptoms less than 7 days.
6. Screening ECG without clinically significant ECG abnormalities.
7. Has laboratory confirmed SARS CoV 2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:
i) PCR positive in sample collected less than 72 hours prior to Day 1; OR
ii) PCR positive in sample collected more than or equal to 72 hours prior to Day 1, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking more than 24 hours, etc.) AND progressive disease suggestive of ongoing SARS CoV 2 infection. OR
iii) Positive COVID-19 Antigen Test.
8. Illness of mild or moderate severity as defined below:
Mild:
i) Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache. AND
ii) Without evidence of breathlessness (RR less than 24) or Hypoxia (Normal saturation SpO2 greater than 94 percent).
9. Moderate:
i) Pneumonia with no signs of severe disease.
ii) Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 in range 90 to 94 percent on room air and Respiratory Rate more or equal to 24 per minute.
10. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28. Agrees to not participate in another clinical trial for the treatment of COVID 19 or SARS CoV 2 through Day 28.
1. Patients with clinical signs of pneumonia plus one of the following: respiratory rate more than 30 breaths per min, severe respiratory distress, SpO2.
2. Requiring mechanical ventilation or ECMO at screening.
3. Estimated glomerular filtration rate (eGFR) less than 30 ml per min (including patients receiving hemodialysis or hemofiltration).
4. Pregnancy or breast feeding.
5. Evidence of multiorgan failure.
6. Allergy to any study medication.
7. Patients on medicinal products which are contraindicated to be used with any study medication.
8. Any malignancy or cerebro vascular complications.
9. Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study.
10. Participated in any other clinical trial or taken investigational drug within 1 month.
11. Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Favipiravir.
12. AST/ALT more than 5.0 ULN or bilirubin more than 3.0 ULN.
13. Serum Uric Acid greater than 3.0 ULN or having symptoms of and being treated for active gout.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method