A Clinical Study to Test the Use of Capsule Molnupiravir in COVID-19 Patients with Mild Symptoms and without Lung Involvement

Phase 3

Completed

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

• Registration Number: CTRI/2021/05/033739
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This is a randomized, multicentric, parallel, open-label, phase III clinicalstudy for evaluating the efficacy and safety of Molnupiravir combined withstandard of care compared to standard of care alone in adult Indian patientswith mild Coronavirus Disease of 2019 (COVID-19). This is a parallel study in which eligible patients will be randomized 1:1ratio into Test: Reference arm. Patients in Test arm will receive Molnupiravir800 mg (4 capsules of200 mg) plus standard of care while the reference armwill receive standard of care alone.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-05-08
• Study Start: 2021-05-24
• Last Update Posted: 2021-12-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1218

Inclusion Criteria

• Patients aged ≥18 and ≤60 years and voluntarily willing to provide signed and dated informed consent.
• Patients with laboratory confirmed COVID-19 by SARS CoV2 positive RT-PCR test (within 48 hours prior to enrollment) 3.
• Patients with mild COVID-19 disease without any evidence of breathlessness.
• For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his/her partner during the study period and for at least 28 days following the last study treatment.

Exclusion Criteria

• Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation.
• Patients with moderate disease or severe disease 3.
• Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN 4.
• Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days 5.
• Patients with a history of acute pancreatitis within 3 months 6.
• Severe renal impairment [creatinine clearance (CrCl) <30 mL/min].

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of hospitalization	Up to Day 14

Secondary Outcome Measures

Name	Time	Method
Rate of hospitalization	Up to Day 28
Proportion of patients with clinical improvement	End of Treatment, Day 10 and Day 14
Mortality rate	Day 14 and Day 28
Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab	End of Treatment, Day 10 and Day 14
Incidence and severity of TEAEs (clinical and laboratory)	All Visits
Proportion of patients discontinued the study drug due to adverse events	All Visits

Trial Locations

Locations (15)

ACSR Government Medical College & Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

All India Institute of Medical Science; 🇮🇳 Raipur, CHHATTISGARH, India

Down Town Hospital; 🇮🇳 Golaghat, ASSAM, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

GMERS Medical College & Hospital; 🇮🇳 Vadodara, GUJARAT, India

Government Medical College & Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Jawahar Lal Nehru Medical College; 🇮🇳 Ajmer, RAJASTHAN, India

Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

MLB Medical College; 🇮🇳 Jhansi, UTTAR PRADESH, India

Narayana Medical College and Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

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ACSR Government Medical College & Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr S K Noushad Ali

Principal investigator

9494828694

mddbnoal@gmail.com