CTRI/2021/05/033904 [Registered on: 31/05/2021] Trial Registered Prospectively
Last Modified On:
03/09/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
To Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19)
Scientific Title of Study
A Prospective, Randomized, Parallel, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
MOLN/MSN/P3-M1/2021 Version 3.1 Dated 18 May 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Pranjal Ausekar
Designation
Director & Head - Clinical Operations
Affiliation
Ardent Clinical Research Services
Address
Ardent Clincal Research Services
Office 304, Level 3, Gagan Kapital Biulding Above Anna Idlirestraunt, Opposite Hotel Kapila, Dhole Patil Road Pune -411001, Maharashtra India. Pune MAHARASHTRA 411001 India
MSN House, Plot No: C-24, Industrial Estate, Sanathnagar, Hyderabad – 500018, Telangana, India Hyderabad TELANGANA 500018 India
Phone
914030438712
Fax
914030438719
Email
krreddy@msnlabs.com
Details of Contact Person Public Query
Name
Mr C Devanpally
Designation
Founder & Director
Affiliation
Ardent Clinical Research Services
Address
Ardent Clincal Research Services
Office 304, Level 3, Gagan Kapital Biulding, Above Anna Idli restraunt, Opposite Hotel Kapila, Dhole Patil Road Pune -411001, Maharashtra India.
Pune MAHARASHTRA 411001 India
Phone
9545817447
Fax
-
Email
cdevanpally@ardent-cro.com
Source of Monetary or Material Support
Ms MSN Laboratories Private Limited,
MSN House : Plot No: C-24, Industrial Estate, Sanathnagar, Hyderabad -500 018, Telangana, India.
Department of Medicine, Golden Nest Phase 1 Rd, near Seven square academy, Golden Nest Phase 1, Queens Park, Mira Road Mumbai MAHARASHTRA
9082805199 - drajitavhadfch@gmail.com
Dr Mahendra Pal Singh
Ganesh Shankar Vidyarthi Memorial Medical College
Department of Medicine, Kanpur Kanpur Nagar UTTAR PRADESH
8765379671 - drmahnedrapalsingh@gmail.com
Dr S S V V Narasinga Rao
Government Medical College and Government General Hospital
Department of Medicine, Srikakulam 532001 Srikakulam ANDHRA PRADESH
9908611119 - drnarasingaraossvv@yahoo.com
Dr Bindumathi Narmada Gottipatti
Guntur Medical College and govt general hospital
Department of Medicine, GGH Internal Road, Sambasiva Pet, Guntur Guntur ANDHRA PRADESH
8099033844 - bindunarmadagottipati@gmail.com
Dr Yandrapati Gnana Sundara Raju
King George Hospital
Clinical research department, 1st floor, ClinicalResearch room, Internal medicine division , King George Hospital, Maharanipeta, Collector office junction, Visakhapatnam ANDHRA PRADESH
9573606609 - drysundarrajuresearch@gmail.com
Dr Jayprakash Appajigol
KLEs Dr. Prabhakar Kore Hospital & M.R.C
2nd Floor, SMO Office, NH Service road, Basava Circle, Chikodi, Nehru Nagar, Belgaum Belgaum KARNATAKA
9844595659 - jayaprakashappajigol@gmail.com
Dr Ajay Bulle
Meditrina Institute of Medical Sciences
Department of Medicine,278, Central Bazar Road, Ramdaspeth, Nagpur, Maharashtra 440012 Nagpur MAHARASHTRA
9921981109 - ajaybulle@yahoo.com
Dr Shiva Kumar
MSHRI- Hitech Covid care Center
MSHRI - Hitech Corvid care Center, 17, Mysore road, next to nayanhalli bus stand, pathanapalya, Bangalore 560039 Mysore KARNATAKA
09060102094 - drshivakumargowda80@gmail.com
Dr Jagadeesh K N
Primary Health Care
Hospital Road, Near Bus stand, Hosapet, Huliyurdurga, Kunigal (taluk), Karnataka, India Tumkur KARNATAKA
9686823666
maruthiclinical23@gmail.com
Dr Vedantha Srinivas Jagadeesan
SIMS Hospital
Department of medicine, Metro Station, No.1, Jawaharlal Nehru Rd, next to Vadapalani, Landmark:, Vadapalani, Chennai, Chennai TAMIL NADU
9677715361 - drvedantha.sj@simshospitals.com
Dr K Vijay Babu
SKS Hospital & Post Graduate Medical Institute
OPD Department, Room No. 10, Ground Floor, SKS hospital road Alagapuram, Salem Salem TAMIL NADU
9944293939 - drvijaymd@hotmail.com
Dr Akash Khobragade
St. Georges Hospital,
Saint George Hospital, Research Department,Supretendant building Grant Medical College and Sir J. J. Group of Hospitals, P DMello Rd, opposite GPO, beside CST Mumbai MAHARASHTRA
9702658822 - drakashk.jj@gmail.com
Dr Satish Chandra
St. Theresas Hospital
Department of Medicine, Erragadda Main Rd, opposite Erragadda Rythu Bazar, Jet Colony, Sanath Nagar, Hyderabad TELANGANA
9440040662 - drvenkateshwarraoavula@gmail.com
Dr Karshan Nandaniya
Surat Institute of Digestive Sciences
2nd floor, room 1, Critical Care Medicine dept, Vijay Nagar Gate 3, Ring Rd, opp. Gandhi College, Majura Gate, Surat GUJARAT
9726610510 - dr_kc79@yahoo.co.in
Dr Dnyaneshwar Halnor
Vijay Vallabh Hospital & Medical Research Centre
Ground Floor, OPD NO, 06, General Medicine, Plot No 423, Tirupati Nagar, Phase 1, Bolinj, Virar [west], Palghar Mumbai MAHARASHTRA
7507779219 - halnordyanu@gmail.com
Dr Changlva Premdeep
Vijaya Hospital
Vijaya Hospital, 16 II, 41-A, Raghava Cine Complex Rd, Pogathota, Nellore, Andhra Pradesh 524001
Nellore ANDHRA PRADESH
Ethics Committee GUntur Medical College and Govt. general hospital
Approved
Ethics committee, GSVM Medical College
Approved
Ethics Committee, St. Theresas Hospital
Approved
Institutional Ethic Committee SKS Hospital & Medical Centre
Approved
Institutional Ethics Committee
Approved
INSTITUTIONAL ETHICS COMMITTEE , GGMC, MUMBAI Grant Govt Medical College JJ Road, JJ Hospital compound Mumbai Central Mumbai Mumbai City Maharashtra - 400008 India ECR/382/Inst/MH/2013/RR-19
Institutional Ethics Committee, King George Hospital
Approved
Intitutional Ethics Committee of KLE and academy of higher education and research
Approved
Meditrina Institute of Medical Sciences, Institutional Ethics Committee.
Approved
MEDSTAR Specialty Hospital Ethics Committee
Approved
SRI DURGAMBA INDEPENDENTETHICS COMMITEE
Approved
Surat Institute of Digestive Sciences Ethics Committee
Approved
VIJAYA ETHICS COMMITTEE
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 200 mg
4 capsules of Molnupiravir 200 mg Twice daily for 5 days will be administered in the IP arm to 609 Covid 19 mild patients.
Comparator Agent
Standard of Care for Covid 19 Management
Standard of Care treatment shall be based on the Clinical Guidance for Management of
Adult COVID-19 Patients, dated 22 Apr 2021. AIIMS/ ICMR-COVID-19 National Task
Force/Joint Monitoring Group (Dte. GHS) and recommendations of Ministry of Health and
Family Welfare, Government of India.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Male or female subjects of 18 years to 60 years both inclusive
2. Subject and/or his/her legally accepted representative willing to give written informed
consent.
3. Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RTPCR
(within 48 hours prior to randomization).
4 Subjects having mild grade of COVID-19 as per MoH & FW guidelines on “Clinical
Management Protocol: COVID-19†as updated from time to time.
a. Mild COVID-19: Patients with uncomplicated upper respiratory tract infection,
may have mild symptoms such as fever, cough, sore throat, nasal congestion,
malaise, headache, without evidence of breathlessness or hypoxia (normal
saturation). (Time for symptom onset and baseline should be no more than 7
days).
ExclusionCriteria
Details
1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient.
2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute
3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl)<30ml/min).
4.Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Molnupiravir.
5.Pregnant or breast-feeding subjects will be excluded.
6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening.
8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV); cancer requiring chemotherapy within the preceding 6 months; unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
9.Subject has a history of alcohol or drug abuse in the previous 6 months.
10.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
12.Anticipated transfer to another hospital which is not a study site within 72 hours.
13.Participated in any other clinical trial or taken investigational drug within 1 month.
14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the subject’s safe participation in and completion of the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).
-Rate of hospitalization from randomization up to Day 14
Secondary Outcome
Outcome
TimePoints
Evaluate the safety of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).
-Rate of hospitalization from randomization up to Day 28
-Proportion of patients with clinical improvement at the end of treatment, Day 10 and Day 14
-Time to clinical improvement from randomization up to day 14
-Change in SARS CoV2 viral load (Cycle Threshold (CT) value of RT-PCR test)
from baseline to end of treatment
-Incidence and severity of TEAEs (clinical and laboratory) during the study
Proportion of patients discontinued the study drug due to adverse events
Target Sample Size
Total Sample Size="1218" Sample Size from India="1218" Final Enrollment numbers achieved (Total)= "1218" Final Enrollment numbers achieved (India)="1218"
Molnupiravir is an antiviral drug acts as an analogue to Covid 19 virus RNA . By inserting incorrect sequence in viral RNA it creates incorrect copies of viral RNA, resulting in decreased or no viral infection in the patients.
The Proposed study is planned to evaluate efficacy and safety of Molnupiravir is 200 mg capsule in mild Covid 19 patients. Total 1218 patients will be enrolled in the study in two arms in 1: 1 ratio. 609 mild Covid 19 positive patients will be enrolled in the study. The given treatment will be known to patients and the study investigators. 4 capsules of 200 mg twice daily along with SOC will be administered to the patients in IP arm for 5 days. In other arm patients will receive only SOC for Covid 19 as per Indian regulatory guidelines. Total duration of participation in the study is for 28 days for each patient.
Subjects will be enrolled after obtaining consent form. 6 study visits are planned in the study, screening, baseline, day 5, day 10, day 14 and day 28. Efficacy analysis will be performed considering the parameters like Complete Blood Count (CBC);Liver Function Test: SGOT, SGPT, Total Bilirubin ;Renal Function Test: Serum Creatinine and eGFR, BUN; Random Blood glucose; D-dimer; C-reactive protein, RT PCR, ECG.
Safety Parameters will be assessed by evaluating TEAE and abnormal lab investigation readings.