This study is to evaluate benefit of adding Molnupiravir over standard treatments in mild COVID-19 subjects

Phase 3

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/06/033938
• Lead Sponsor: Dr Reddys Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Subjects will be enrolled in the study if they meet all the following criteria:

2.Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements

3.Male or female patients between 18 and 60 years of age (both inclusive)

4.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected <=5 days prior to randomization)

5.Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization.

6.Patients with mild COVID-19 and have following symptoms and signs prior to randomization <=5 days prior to randomization

7.Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia.

8.As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Directorate General Of Health Services) Ministry of Health & Family Welfare, Government of India- clinical guidance for management of adult COVID-19 patients, dated 22-Apr-2021.

9.Is willing and able to take oral medication

10.Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient

Exclusion Criteria

Subjects will be entered into the study only if they meet none of the following criteria

1.Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization

2.Pregnancy or lactation

3.History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment

4.Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation

5.Tested positive for Human immunodeficiency virus (HIV),

Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection

6.Abnormal laboratory findings at screening

Aspartate aminotransferase (AST) >3X upper limit of normal

Alanine aminotransferase (ALT) >3X upper limit of normal

Absolute neutrophil count <500/mm3 or per microliter

Platelet count <100,000 per microliter or /mm3

Patients who received a platelet transfusion in the 5 days prior to randomization

7.Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to:

8.Participants who are not expected to survive longer than 48 hours at the time of randomization, or

Participants with a recent history of mechanical ventilation, or

Participants with conditions that could limit gastrointestinal absorption of capsule contents

9.Receipt of following medication/treatment:

Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment

Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit)

10.Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer)

Study & Design

• Study Type: Interventional
• Study Design: Not specified