Health Condition 1: J069- Acute upper respiratory infection,unspecified Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Molnupiravir capsules: 05 Days treatment. 1600 mgs/twice a day/Oral
Control Intervention1: Standard of Care Therapy: Standard of Care Therapy as per the Institution Practice and Based o
Sponsors
Aurobindo Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and/or female patients aged >= 18 and 2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. 3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. 4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. a. Respiratory rate >= 24/min, breathlessness b. SpO2: 90% to 5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). 6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. 7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. Medically acceptable forms of contraceptive include: a. Hormonal contraceptives (at least 1 month before screening visit) b. Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide) c. Intrauterine device (IUD)
Exclusion criteria
Exclusion criteria: Inclusion Criteria: 1. Male and/or female patients aged >= 18 and 2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. 3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. 4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. a. Respiratory rate >= 24/min, breathlessness b. SpO2: 90% to 5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). 6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. 7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. Medically acceptable forms of contraceptive include: a. Hormonal contraceptives (at least 1 month before screening visit) b. Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide) c. Intrauterine device (IUD) Exclusion Criteria: 1. Patients with known hypersensitivity to any of the excipients of the study medication or to any other similar class of drugs. 2. Patients who participated in any other clinical trial of an experimental treatment for COVID-19 within 90 days prior to randomization. 3. Patients infected post vaccination of either 1st or 2nd dose. 4. Patients with pulse rate 5. Patient with severe COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen >=0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO). 6. Patients have hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X upper limit of normal at screening. 7. Patients with platelet count 8. Patients with AIDS-defining illness in the past 6 months. 9. Patients with uncontrolled co-morbid conditions such as hypertension, diabetes, cardiovascular disease, chronic lung/ liver/ kidney disease, cerebro-vascular disease as per the investigatorâ??s discretion. 10. Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation. 11. Patients with Absolute Neutrophil Count (ANC) 12. Patients currently administering immunosuppressive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinical improvement at Day 14. Clinical improvement is defined as 2-point decrease in clinical progression scale as recommended by WHO. Timepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients with clinical improvement at Day 28. â?¢ Time to clinical improvement from randomization up to 28 days. â?¢ Mortality rate at Day 28. â?¢ Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab at the end of treatment, Day 14 and Day 28. â?¢ Change in SARS CoV-2 viral load (Cycle Threshold (CT) value of RT-PCR test) from baseline to end of the treatment, Day 14 and Day 28. Timepoint: Day 28 | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed