Study to evaluate the efficacy and safety of Molnupiravir capsules Compare with the with Standard of Care Medications Care alone in patients who are suffering with Moderate COVID-19 disease

Phase 3

Not yet recruiting

• Conditions: Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2021/08/035424
• Lead Sponsor: Aurobindo Pharma Limited

Brief Summary

This is a phase 3, prospective, open-label,randomized, multicentre, a parallel study in patients with Moderate COVID-19 disease.This study will be conducted in two parts. In part 1, the study will beconducted on 100 patients. Part 2 of this study will be continued to completethe enrollment of remaining patients to achieve the randomization of 1284 patientsconsidering two parts. The total duration of study for each patient will beapproximately 5 weeks including a screening period. This study will be conductedin approximately 20 sites across India.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-08
• Study Start: 2021-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Male and/or female patients aged ≥ 18 and ≤ 60 years of age (both inclusive).
• 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.
• Respiratory rate ≥ 24/min, breathlessness b.
• SpO2: 90% to ≤ 93% on room air 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) Inclusion Criteria: 1.Male and/or female patients aged ≥ 18 and ≤ 60 years of age (both inclusive).
• 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 < 50 beats per minute at rest at the time of screening and randomization.
• 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 <100,000/μL or received a platelet transfusion within 5 days prior to randomization.
• 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 investigator’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) < 500 mm3.
• 12.Patients currently administering immunosuppressive treatments within 30 days of prior to randomization.
• Patients who have any medical condition(s) or has any medical condition(s) which would likely interfere with the conduct or interpretation of the study as per the investigator’s discretion.

Exclusion Criteria

• Inclusion Criteria: 1.Male and/or female patients aged ≥ 18 and ≤ 60 years of age (both inclusive).
• 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.
• Respiratory rate ≥ 24/min, breathlessness b.
• SpO2: 90% to ≤ 93% on room air 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 < 50 beats per minute at rest at the time of screening and randomization.
• 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 <100,000/μL or received a platelet transfusion within 5 days prior to randomization.
• 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 investigator’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) < 500 mm3.
• 12.Patients currently administering immunosuppressive treatments within 30 days of prior to randomization.
• Patients who have any medical condition(s) or has any medical condition(s) which would likely interfere with the conduct or interpretation of the study as per the investigator’s discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvement is defined as 2-point decrease in clinical progression scale as recommended by WHO.	Day 28
Proportion of patients with clinical improvement at Day 14.	Day 28

Secondary Outcome Measures

Name	Time	Method
•Proportion of patients with clinical improvement at Day 28.	•Time to clinical improvement from randomization up to 28 days.

Trial Locations

Locations (6)

Baramati Hospitals Pvt.Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Health Point Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Pulse Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

RCSM Govt. Medical College and CPR Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

St Theresas Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Vedant Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Baramati Hospitals Pvt.Ltd

🇮🇳Pune, MAHARASHTRA, India

Dr Pramod Sonba Atole

Principal investigator

9970997767

drpramodatole@gmail.com