Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with mild COVID-19 disease

Phase 3

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2021/07/034588
• Lead Sponsor: Aurobindo Pharma Limited

Brief Summary

This is a phase 3, prospective, open label, randomised, multicentre, parallel study in patients with mild COVID-19 disease. This study will be conducted in approximately 20 sites across India. The total duration of study for each patient will be approximately 5 weeks including screening period.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-09
• Study Completion: 2021-08-18
• Study Start: 2021-10-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1220

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 uncomplicated upper respiratory tract symptoms may have one of the symptoms of fever, cough, sore throat, nasal congestion, malaise, headache or any other signs and COVID-19 symptoms without any evidence of breathlessness or hypoxia (normal saturation) within 5 days prior to the randomization.
• 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 one of the following symptoms at the time of screening.
• Respiratory rate ≥ 24/min, breathlessness b.
• SpO2: ≤ 93% on room air 5.Patients with pulse rate < 50 beats per minute at rest at the time of screening and randomization 6.Patients are currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization.
• 7.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.
• 8.Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization.
• 9.Patients with AIDS-defining illness in the past 6 months.
• 10.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.
• 11.Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation.
• 12.Patients with Absolute Neutrophil Count (ANC) < 500 mm3.
• 13.Patients currently administering immunosuppressive treatments within 30 days of prior to randomization or systemic corticosteroids.
• 15.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
Rate of hospitalization of patients from randomization up to Day 14.	Rate of hospitalization of patients from randomization up to Day 14. | Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate ≥ 24/ minute and SpO2≤93% in room air requiring oxygen supplementation.
Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate ≥ 24/ minute and SpO2≤93% in room air requiring oxygen supplementation.	Rate of hospitalization of patients from randomization up to Day 14. | Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate ≥ 24/ minute and SpO2≤93% in room air requiring oxygen supplementation.

Secondary Outcome Measures

Name	Time	Method
•Rate of hospitalization of patients from randomization up to Day 28.	•Proportion of patients with clinical improvement at end of treatment, Days 10 and 14.

Trial Locations

Locations (17)

AnandSurgicalHospitalPrivateLimited; 🇮🇳 Ahmadabad, GUJARAT, India

DHS Multispecialty Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

District Civil Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Dr. Devineni Sai Sahul; 🇮🇳 Hyderabad, TELANGANA, India

Dr. Vaibhav Lotake, Pulse Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Dr.DY.Patil Hospital Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

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

Induss Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Lotus Multi Speciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Ojas Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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AnandSurgicalHospitalPrivateLimited

🇮🇳Ahmadabad, GUJARAT, India

DrPankaj Bharatbhai Vyas

Principal investigator

9726630128

nirmit.clinicalreserach@gmail.com