A study of Favipiravir in patients with mild to moderate coronavirus disease (COVID-19)
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/06/025799
- Lead Sponsor
- Cipla Ltd
- Brief Summary
The studyis a randomized, open label,prospective, comparative, parallel group, multicentre study to evaluateefficacy and safety of Favipiravir with
supportivecare versus supportive care alone in subjects with mild to moderatecoronavirus disease (COVID-19)
The objectiveof study is to evaluate efficacy andsafety of Favipiravir with supportive care versus supportive care alone insubjects with mild to moderate coronavirus disease (COVID-19).
CRO for this trial will be CBCC Global Research
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 156
- A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative.
- Subjects of either gender and age between 18 and 75 years.
- Confirmed diagnosis of mild to moderate COVID-19.
- (positivity in RTPCR 2019-nCoV test on respiratory tract specimens).
- In case of moderate COVID-19, subjects with CT or Chest X-ray documented pneumonia.
- Subjects with pyrexia (axillary ≥37℃ or oral ≥37.5℃, or rectal≥38℃) or either respiratory rate >24/min and <30/min or cough.
- Subjects within 7 days from symptom onset or within 48 hours of laboratory diagnosis of SARS-CoV2.
- Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care.
- Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR<30ml/min).
- Subjects with oxygen saturation (SPO2) ≤90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg. 4.
- 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.
- Subjects with gout or hyperuricemia.
- Pregnant or breast-feeding subjects.
- Subject is using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
- Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
- Subject has a history of alcohol or drug abuse in the previous 6 months.
- Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- Anticipated transfer to another hospital which is not a study site within 72 hours.
- Participated in any other clinical trial or taken investigational drug within 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour] Up to 28 days
- Secondary Outcome Measures
Name Time Method Time from randomization to clinical recovery(clinical recovery:normalization of pyrexia,respiratory rate and SPO2 and relief of cough that is maintained for at least 72 hours).Incidence of deterioration/aggravation of pneumonia.Time from randomization to resolution of pyrexia.Time from randomization to relief of cough.Time from randomization to relief of dyspnoea.Time to discharge from hospital.ICU admission rate. Adverse events(Serious/Non-serious,Expected/Unexpected,Related/Not Related) Up to 28 days. Till discharge/death whichever is earlier (up to Day 28)
Trial Locations
- Locations (8)
B.J.G.M College and Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
Fortis Hospital
🇮🇳Kolkata, WEST BENGAL, India
Global Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Government Medical College & Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Noble Hospital
🇮🇳Pune, MAHARASHTRA, India
Smt. Kashibai Navale Medical College and General Hospital
🇮🇳Pune, MAHARASHTRA, India
Sterling Cancer Hospital
🇮🇳Ahmadabad, GUJARAT, India
B.J.G.M College and Sassoon General Hospital🇮🇳Pune, MAHARASHTRA, IndiaDr Rohidas BorsePrincipal investigator9923912525Rohidas_borse@yahoo.co.in