CTRI/2021/05/033739 [Registered on: 21/05/2021] Trial Registered Prospectively
Last Modified On:
12/11/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Clinical Study to Test the Use of Capsule Molnupiravir in COVID-19 Patients with Mild Symptoms and without Lung Involvement
Scientific Title of Study
A Phase III, Multicentric, Prospective, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Molnupiravir in Adult Indian Patients with Mild COVID-19
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
HCR/III/MOLCOV/04/2021-01; Version 3.0 Dated 07/May/2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Sreenivasa Chary S
Designation
General Manager
Affiliation
Hetero Labs Limited
Address
7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India.
Hyderabad TELANGANA 500018 India
Phone
04023704923
Fax
Email
sreenivasa.chary@heterodrugs.com
Details of Contact Person Public Query
Name
Dr Shubhadeep Sinha
Designation
Sr. Vice President
Affiliation
Hetero Labs Limited
Address
7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India.
Institutional Human Ethics Committee, 1st Floor College Building, GMERS Medical College&Hospital,Gotri,Vadodara-390021,Gujarat, India ECR/28/Inst/GJ/2013/RR-19
Approved
Institutional Ethics Committee National Institute of Medical Sciences and Research(NIMS) Shobha Nagar, Jaipur-Delhi Highway NH-11C Jaipur-303121 ECR/665/Inst/RJ/2014/RR-17
Approved
Institutional Ethics Committee ,Gandhi Medical College/ Hospital, Musheerabad, Secunderabad,Telangana-500003 ECR/180/Inst/AP/2013/RR-19
Approved
Institutional Ethics Committee for Human Research, Jail Road, Indira Avenue, Vadodara, Gujarat 390001 ECR/85/Inst/GJ/2013/RR-19
Submittted/Under Review
Institutional Ethics Committee GGMC, Mumbai Grant Govt Medical College J.J Road J.J Hospital Compound Mumbai -400008 Maharashtra ECR/382/Inst/MH/2013/RR-19
Approved
Institutional Ethics Committee Jawahar Lal Nehru Medical College, Kala Bagh,Ajmer-305001,Rajasthan ECR/1156/Inst/RJ/2018
Approved
Institutional Ethics Committee, ACSR Government Medical College & Hospital,Dargamitta,Nellore-524004 ECR/961/Inst/AP/2017/RR-20
Approved
Institutional Ethics Committee, Government Medical College & Govt. General Hospital, Srikakulam - 532001 Andhra Pradesh, India ECR/492/Inst/AP/2013/RR-20
Approved
Institutional Ethics Committee, Nirmal Hospital Institutional Ethics Committee, Nirmal Hospital , Jhansi Opp Gate no 3, MLB Medical college, Jhansi (U.P),284128- India ECR/325/Inst/UP/2013/RR-19
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Molnupiravir and Standard of Care
Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 hours for 5 days
AND
Standard of Care
Comparator Agent
Standard of Care
Standard of Care as per the ICMR Clinical Management Protocol
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Patients aged ≥18 and ≤60 years and voluntarily willing to provide signed and dated informed consent.
2. 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.
4. 4. 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.
ExclusionCriteria
Details
1. Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation.
2. 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]
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Rate of hospitalization
Up to Day 14
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="1218" Sample Size from India="1218" Final Enrollment numbers achieved (Total)= "1218" Final Enrollment numbers achieved (India)="1218"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized, multicentric, parallel, open-label, phase III clinical
study for evaluating the efficacy and safety of Molnupiravir combined with
standard of care compared to standard of care alone in adult Indian patients
with mild Coronavirus Disease of 2019 (COVID-19). This is a parallel study in which eligible patients will be randomized 1:1
ratio into Test: Reference arm. Patients in Test arm will receive Molnupiravir
800 mg (4 capsules of
200 mg) plus standard of care while the reference arm
will receive standard of care alone.