Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Favipiravir 200mg Tablets: Dosage Form: Tablets,
Dosage Frequency: 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days,
Mode of Admi
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures 2. Age > 18 years at the time of signing ICF 3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization) 4. Radiographic evidence of pneumonia 5. Respiratory rate > 24 breaths per minute 6. Any two of the following signs or symptoms suggestive of COVID-19: cough/shortness of breath or difficulty in breathing/fever/chills/muscle pain/sore throat/new loss of taste or smell 7. Oxygen saturation (SpO2) 8. Time interval between symptoms onset and randomization less than 10 days 9. Currently hospitalized and requiring medical care for COVID 19 10. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum pregnancy test 11. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment; 12. Not participating in any other interventional drug clinical studies before completion of the present study.
Exclusion criteria
Exclusion criteria: Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. Severe respiratory distress and PaO2/FiO2 Inability to intake or tolerate oral medications. Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN Gout/history of gout or hyperuricemia (above the ULN) Prolonged QT, defined as QTcF >=450 milliseconds for men and as QTcF >=470 for women Known severely reduced LV function (ejection fraction Heart rate >= 125 beats per minute Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). Known allergy or hypersensitivity to favipiravir or umifenovir Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 Known severe renal impairment [creatinine clearance (CrCl) Asthma or chronic obstructive lung disease Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). Pregnant or lactating women; Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. Clinical prognostic non-survival or requirement of palliative care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to clinical cure (defined as resolution of baseline clinical signs and symptoms of COVID-19 infection and at least 2 point improvement on WHO Ordinal Scale for Clinical Improvement) (Time frame-28 days).Timepoint: Upto 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality rate at day 4/7/10/14/28Timepoint: On day 4/7/10/14;Frequency of serious adverse eventsTimepoint: Randomization to hospital discharge (or day 28, which ever is earlier);Rate of % improvement in radiological findings at dischargeTimepoint: at the time of discharge;Rate of Clinical cure at day 4/7/10/14/28Timepoint: On day 4/7/10/14;Rate of SARS-CoV-2 RT-PCR negativity in both oropharyngeal swab and nasopharyngeal swab at day 4/7/10/14/28Timepoint: On day 4/7/10/14;Time from randomization to first time requirement of non- invasive ventilation/intubation/mechanical ventilation/ECMOTimepoint: From randomization to first use of high flow supplemental oxygen/non-invasive ventilation/mechanical ventilation/ extracorporeal membrane oxygenation (or day 28, which ever is earlier);Time from randomization to hospital dischargeTimepoint: From randomization to hospital discharge (or day 28, which ever is earlier) | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Ltd
Outcome results
None listed