CTRI/2021/06/034015 [Registered on: 05/06/2021] Trial Registered Prospectively
Last Modified On:
08/11/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Clinical Study with Molnupiravir Capsules 800mg in COVID-19 Patients with Mild symptoms.
Scientific Title of Study
A Multi-Centre, Prospective, Open Label, Parallel, Randomized, Clinical Trial to
Assess the Efficacy And Safety Of Molnupiravir 800 Mg Capsules And Standard of Care
(SoC) Compared To Standard of Care (SoC) Only In Mild Patients With Polymerase Chain Reaction (PCR)
Confirmed COVID-19.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NV-05-1154-2021, Version No 1.0 Dated 14.05.2021
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Vimla Dsouza
Designation
Associate Director - Clinical Operation
Affiliation
Arcolab Pvt Ltd
Address
19/2, SKR Towers, 15th Cross Rd, Dollar Layout, 4th Phase, J. P. Nagar,
Bengaluru
Bengaluru Bangalore KARNATAKA 560078 India
Phone
09844224041
Fax
Email
Vimla.Dsouza@arcolab.com
Details of Contact Person Scientific Query
Name
Dr Vimla Dsouza
Designation
Associate Director - Clinical Operation
Affiliation
Arcolab Pvt Ltd
Address
19/2, SKR Towers, 15th Cross Rd, Dollar Layout, 4th Phase, J. P. Nagar,
Bengaluru
Bangalore KARNATAKA 560078 India
Phone
9844224041
Fax
Email
Vimla.Dsouza@arcolab.com
Details of Contact Person Public Query
Name
Dr Vimla Dsouza
Designation
Associate Director - Clinical Operation
Affiliation
Arcolab Pvt Ltd
Address
19/2, SKR Towers, 15th Cross Rd, Dollar Layout, 4th Phase, J. P. Nagar,
Bengaluru
Room no 239, Dept of medicine 2nd Floor, OPD. Building, All India Institute of Medical Science, MIHAN, Sumthana, Nagpur-441108, Maharashtra, India Nagpur MAHARASHTRA
9823134598
rajashreekhot.s.khot@gmail.com
Dr Aman Khanna
Aman Hospital and Research Cente
Room # 01, Ground Floor-Aman Hospital and Research Center-15, Shashwat, Opp. E.S.I Hospital, Gotri Road, Vadodara-390021 Vadodara GUJARAT
9904402122
amankhanna1974@gamil.com
Dr Dipu T S
Amrita Institute of Medical Sciences
Amrita Institute of Medical Sciences, Ponekkara, Eapally, Kochi-682041 Ernakulam KERALA
09746106288
diputsmck@gmail.com
Dr Yateesh J
BGS Global Institute of medical sciences and Hospital
Intensivist & HOD ICU, Assistant Professor, Room no 402, 4th floor, Department of General medicine, BGS Global Institute of medical sciences and Hospital,
No.67, BGS Health and Education city, Uttarahalli Main road, Kengeri, Bengaluru Bangalore Rural KARNATAKA
09741333320
Yateeshjbgsgims@gmail.com
DrShibu Raj PS
Dr.SM CSI Medical College Hospital
Dr.SM CSI Medical College HospitalParassala Vellarada Rd, Karakonam, Trivandrum Kerala 695504 Thiruvananthapuram KERALA
09885714189
drshiburajps21@gmail.com
Dr Meenakshi shah
GMERS Medical College and General Hospital
Room # NA, Department of medicine 7th Floor, GMERS Medical College and General Hospital Gotri, Gotri Road, Old TB Campus, Vadodara- 390021, Gujarat India. Vadodara GUJARAT
9558275888
drmeenakshi30@yahoo.com
Dr Vinoth Kumar
GOVERNMENT CHENGALPATTU MEDICAL COLLEGE & HOSPITAL
Room number 35, Senior Resident, Department of Chest and Tuberculosis, Chengalpattu Medical College and Hospital,No.1 G.S.T.Road,Chengalpattu-603001. Kancheepuram TAMIL NADU
9962347572
mbbs.vinoth@gmail.com
Dr Meenakshi Bhattacharya
Government Medical College
Dept of medicine 2nd Floor,Room # NA, Government Medical College, Panchakki road, Aurangabad- 431001, Maharashtra, India. Aurangabad MAHARASHTRA
9922931527
mabhattacharya@gmail.com
Dr Deepti Chand
Government Medical College and Hospital
Room # NA, Department of Research room, 2nd Floor, Near Ward 33, Government Medical College and Hospital, Medical College Square Road, Nagpur-440003, Maharashtra, India. Nagpur MAHARASHTRA
9823257601
dachand.ngp@gmail.com
Dr Sunil Naik
Govt. Medical College & Govt. General Hospital (Old RIMSGGH)
OPD No 13, 1st floor, Dept of general medicine, Govt medical college & general hospital srikakulam-532001 Srikakulam ANDHRA PRADESH
9440828299
rimsresearch@gmail.com
Dr Kanugula Sudheer
Great Eastern Medical School and Hospital
Department of General Medicine, Room No NA, Great Eastern Medical School and Hospital, Ragolu,Srikakulam-532484,Andhra Pradesh, India Srikakulam ANDHRA PRADESH
9666123122
drksudheerresearch@gmail.com
Dr Somanath Dash
GSL Medical college
Department of Pulmonology, Room no -NA GSL Medical college, Lakshmi Puram, Rajahmundry, Andhra Pradesh-533296 East Godavari ANDHRA PRADESH
9490875703
drsomanathdashresearch@gmail.com
Dr Pearlsy Grace Rajan
Hindu Mission Hospital
Room number 42, Dept of General Medicine, Ground floor, Hindu mission hospital, #103, GST road, West Tambaram Chennai -600045 Chennai TAMIL NADU
9566005007
pearlsyrajan@gmail.com
Dr Radha Munje
Indira Gandhi Government Medical College and Hospital
Room # NA, Ground Floor, Dept of respiratory medicine Indira Gandhi Government Medical College and Hospital, C. A Road Nagpur- 440018, Maharashtra, India. Nagpur MAHARASHTRA
9422147752
radhamunje@yahoo.com
Dr Mohammad shameem
Jawaharlal Nehru Medical College
Room No 1, Dept of PB and Respiratory diseases, Ground Floor, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh 202002, Uttar Pradesh, India. Aligarh UTTAR PRADESH
9412731835
mshameem@myamu.ac.in
Dr Jigar Modia
Jupiter Hospital
Room no 3, Dept of General Medicine, Jupiter Hospitals
Sunpharma atladra road,Opp.ICAI Bhavan,atladra, Vadodara, Gujarat, 390012
Vadodara GUJARAT
99913041639
drjigarmodianm@gmail.com
Dr Sundar raju
King George Hospital
Room No 2, Dept of General Medicine, King George Hospital, Rsjendraprasad Ward,Maharanipeta,Visakhapatnam-30002,Andhrapradesh,India. Visakhapatnam ANDHRA PRADESH
9573606609
drysundarrajuresearch@gmail.com
Dr Jayaprakash Appajigol
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre
Room no 11, Departmental of General Medicine,Ground floor, KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi - 590010, Karnataka, India Belgaum KARNATAKA
9844595659
jayaprakashappajigol@gmail.com
Dr Mohammad Mirvaz Zulfikar
Malabar Medical College Hospital and Research Centre
Malabar Medical College Hospital and Research Centre, P.O.Modakkallur, Atholi, Kozhikode- 673623,Kerala Kozhikode KERALA
04962701800
mohammedmzulfikar@gmail.com
Dr Sagar Sudhir Mandlik
Navsanjeevani Hospital Raghukul sankul
Room No. 2, Critical care unit, Floor no 2, Vakratunda Hospital Pvt Ltd, Near Bandhuraj Palace, Mumbai Agra Highway, Pathardi Phara, Nashik -422010
Nashik MAHARASHTRA
9225343885
sagarmandlik007@yahoo.com
Dr Sumer Choudhary
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
Room # NA,3rd Floor, Dept of respiratory medicine & plastic surgery, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur- 440019, Maharashtra, India. Nagpur MAHARASHTRA
9822267975
drsumerchaudhary91@gmail.com
Dr Vivek G
Rajarajeswari Medical College and Hospital(RRMCH)
Room no 5, Dept of Pulmonary medicine, Rajarajeswari Medical College and Hospital ,Ground Floor,202, Kambipura, Mysore Road, Bangalore – 560074, Karnataka Bangalore Rural KARNATAKA
9739701000
vivek.g27@gmail.com
Dr Yogesh Sharma
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Room # NA, Dept of General medicine 2nd Floor, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Belapur Road, Kalwa, Thane-400605, Maharashtra, India Thane MAHARASHTRA
9820192129
dryogeshsharmamd@yahoo.com
Dr B K Gupta
S.P. Medical College and A.G. of Hospitals
HOD room, Room # NA, Near ICU, Dept of medicine Research Cell, Haldi Ram Mool Chand,B-block,PBM hospital campus,SP Medical College and A.G.Hospitals, Bikaner-Rajasthan-India. 334003 Bikaner RAJASTHAN
9829176143
bkgbkn@rediffmail.com
Dr Sandeep Jain
Tagore Hospital And Research Institute
Room # NA, Dept of general medicine Ground Floor, Tagore Hospital and Research Institute, Tagore Lane, Sector-7, Shipra Path, Madhyam Marg, Mansarovar, Jaipur, Rajasthan- 302020, India Jaipur RAJASTHAN
INSTITUTIONAL ETHICS COMMITTEE RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL NO. 202, KAMBIPURA, MYSORE ROAD, BENGALURU, KARNATAKA - 560074 INDIA
Approved
ANAND INSTITUTIONAL ETHICS COMMITTEE, ANAND MULTISPECIALTY HOSPITAL, VADODARA B TOWER SUNDARVAN COMPLEX, BESIDE IOCL PETROL PUMP NEAR GORWA ITI, VADODARA, GUJARAT - 390016 INDIA
Approved
ETHICS COMMITTEE, S.P. MEDICAL COLLEGE & A.G. HOSPITALS, HRMC CARDIOVASC ULA R SCIENCES & RESEARCH CENTER, BIKANER, RAJASTHAN - 334003, INDIA
Approved
Human Ethics Committee Dr. SMCSI Medical College Karakonam Thiruvananthapuram Thiruvananthapuram Thiruvananthapuram Kerala - 695504 India
Approved
IEC KING GEORGE HOSPITAL, KINGGEORGEHOSPITA, MAHARANIPET, COLLECTOROFFICEJUNCTION VISAKHAPATNAM, ANDHRA PRADESH - 530002 INDIA
Approved
INSTITUTIONAL CLINICAL ETHICS COMMITTEE, RGMC AND CHATRAPATI SHIVAJI MAHARAJ HOSPITAL, THANE-BELAPUR RD, KALWA, THANE-400605, MAHARASHTRA - 400605 INDIA
Submittted/Under Review
INSTITUTIONAL ETHICAL COMMITTEE, CHENGALPATTU MEDICAL COLLEGE, GST ROAD, KANCHIPURAM TAMIL NADU - 603001 INDIA
Approved
Institutional Ethics Committee Amrita Institute of Medical Sciences AIMS-Ponekkara Kochi Edappally Ernakulam Kerala - 682041 India
Approved
INSTITUTIONAL ETHICS COMMITTEE AMAN HOSPITAL AND RESEARCH CENTRE 15 SHASHWAT, OPP, E.S.I HOSPITAL SARABHAI, GOTRI ROAD VADODARA GUJARAT - 390021 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE FOR CLINICAL TRIAL, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PLOT NO 2, SECTOR 20 1ST FLOOR, OPD BUILDING, MIHAN, NAGPUR, MAHARASHTRA - 441108 INDIA
Submittted/Under Review
Institutional Ethics Committee Malabar Medical College Hospital,Modakkallur Atholi Kozhikode Kozhikode Kerala - 673323 India
Approved
INSTITUTIONAL ETHICS COMMITTEE, BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES, NO 67, BGS HEALTH AND EDUCATION CITY, UTTARAHALLI ROAD, KENGERI, BENGALURU, KARNATAKA – 560060, INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, GEMS, GREAT EASTERN MEDICAL SCHOOL AND HOSPITAL, RAGOLU SRIKAKULAM SRIKAKULAM, ANDHRA PRADESH - 532484 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE, DEPARTMENT OF PHARMACOLOGY, AURANGABAD, MAHARASHTRA - 431001 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, GOVT. MEDICAL COLLEGE AND GOVT. GENERAL HOSPITAL, BALAGA, SRIKAKULAM, ANDHRA PRADESH - 532001 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, GSLM CGH, GSL MEDICAL COLLEGE HOSPITAL, 6-265, LAKSHMIPURAM NH-16,RAJANAGARAM, RAJAHMUNDRY, ANDHRA PRADESH - 533296 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, HINDU MISSION HOSPITAL, NO 103 GST ROAD , WEST TAMBARAM CHENNAI, KANCHIPURAM, TAMIL NADU - 600045 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI GOVT. MEDICAL COLLEGE , DEPT. OF PHARMACOLOGY, CENTRAL AVENUE ROAD, NEAR MAIN RAILWAY STATION, NAGPUR, MAHARASHTRA- 440018 INDIA
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE, JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL, ALIGARH MUSLIM UNIVERSITY, CIVIL LINE KOIL, ALIGARH, UTTAR PRADESH - 202002 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, KLE UNIVERSITY KLE DR.PK HOSPITAL AND MRC, NEHRU NAGAR, BELAGAVI, KARNATAKA - 590010 INDIA
Approved
INSTITUTIONAL ETHICS COMMITTEE, NKP SALVE INSTITUTE OF MEDICAL SCIENCES, DIGDOH HILLS, HINGNA ROAD NAGPUR MAHARASHTRA - 440019 INDIA
Approved
INSTITUTIONAL HUMAN ETHICS COMMITTEE, GMERS MEDICAL COLLEGE AND HOSPITAL, OLD TB HOSPITAL CAMPUS, GOTRI, VADODARA, GUJARAT - 390021 INDIA
TAGORE HOSPITAL ETHICS COMMITTEE, TAGORE HOSPITAL AND RESEARCH INSTITUTE, TAGORE LANE, SECTOR-7, SHIPRA PATH, MADHYAM MARG, MANSAROVAR, JAIPUR, RAJASTHAN - 302020 INDIA
Submittted/Under Review
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 800 mg capsules
Molnupiravir 800 mg (4 capsules of 200 mg or 2 capsules of 400 mg) (BID) + Standard of care.
Patients will be instructed to take Molnupiravir 800 mg (4 x 200 mg or 2 x 400 mg) capsules every 12 hours, for 5 days-10 doses total) orally one hour before food intake with a glass of water.
Comparator Agent
Standard of Care
The standard of care will be as per physician recommendation or prescription in line to -Revised Guidelines on Clinical Management of COVID-19 by Government of India, Ministry of Health & Family Welfare Directorate General of Health Services, (EMR Division), Version 05, 03rd July 2020..
Treatment may include Oral medications like Ivermectin 12mg, once daily, anti-pyretic, anti-tussive multivitamins, and antibiotics
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements.
Male or female patients between 18 and 60 years of age (both inclusive).
Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected ≤5 days prior to randomization)
Patients with mild COVID-19 (non-hospitalized) and have following symptoms and signs within 3 to 5 days prior to randomization.
Patients having mild COVID-19 with a score of 2 or 3 on the 10-point ordinal scale of clinical status
Patients who are able to consume oral medications.
Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
Females who are not pregnant or breastfeeding
ExclusionCriteria
Details
Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator.
Uncontrolled comorbid medical conditions.
Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization
Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation.
If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient.
If patient has a history of 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.
If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis.
Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, oseltamivir or any other anti-viral treatments) during study participation as per investigator’s discretion.
A baseline heart rate of < 60 beats per minute at rest
If patient 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: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
Rate of hospitalization from randomization up to day 14.
Rate of hospitalization from randomization up to day 14.
Secondary Outcome
Outcome
TimePoints
Rate of hospitalization from randomization up to day 28.
Proportion of patients with clinical improvement at the end of treatment day 10 and 14.
Time to clinical improvement from randomization up to day 14.
Mortality rate at day 14.
Mortality rate at day 28.
28 days
Target Sample Size
Total Sample Size="1220" Sample Size from India="1220" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"