CTRI/2021/06/033992 [Registered on: 04/06/2021] Trial Registered Prospectively
Last Modified On:
23/09/2021
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 to estimate the efficacy and safety of formulation of Molnupiravir in patients with Mild COVID-19 infection.
Scientific Title of Study
A prospective, randomized, parallel, multicentric, phase III 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 patients with polymerase chain reaction (RT-PCR) confirmed Mild Covid-19 infection.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
OPT-MOL-001, Version Number 3.0, dated 12.05.2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
General Manager- Medical Monitoring and Safety - Monitoring
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India
Faridabad HARYANA 121003 India
Phone
9771407484
Fax
0129-6613520
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Optimus Pharma Pvt Ltd
Sy No37/A & 37/P, Plot 6P 2Fl,
Signature Towers, Kothaguda
Hyderabad, 500084
Telangana, India.
Primary Sponsor
Name
Optimus Pharma Pvt Ltd
Address
Sy No37/A & 37/P, Plot 6P 2Fl,
Signature Towers, Kothaguda
Hyderabad, 500084
Telangana, India.
Ashirwad Hospital and Research Centre, Near Jijamata Udyan Section, Ulhasnagar 421004, Maharashtra, India Thane MAHARASHTRA
919822017445
writetoshrikant@rediffmail.com
Dr Deepak Bhanudas Varade
BAJ RR Hospital Medical & Research Centre
P 14 MIDC Phase 1, College Rd, Dombivali East, Dombivali, Maharashtra 421203 Thane MAHARASHTRA
919870409142
deepak.varade@gmail.com
Dr Ajit Avhad
Family Care Hospitals - Multispeciality Hospital
Family Care Hospital, Golden Nest Phase 1 Rd, near Seven square academy, Golden Nest Phase 1, Queens Park, Mira Road, Maharashtra 401107 Thane MAHARASHTRA
919082805199
drajitavhadfch@gmail.com
Dr SSVV Narasinga Rao
Govt. Medical College & Govt. General Hospital (Old RIMSGGH)
Research Wing, 2nd Floor, Beside FM Ward, Govt. Medical College & Govt. General Hospital ,Srikakulam-532001 , A.P ,India. Srikakulam ANDHRA PRADESH
3rd Floor, Room No 310, Department of Medicine, New India Mill Compound Nr Jetalpur Bridge, Jetalpur Rd, Vadodara, Gujarat 390020 Vadodara GUJARAT
91-9925529932
karishma156@gmail.com
Dr Sumit Poddar
HP Poddar Memorial Clinic and Nursing Home
56H, Beleghata Main Rd, Subhas Sarobar Park, Phool Bagan, Beleghata, Kolkata, West Bengal 700010 Kolkata WEST BENGAL
919830599468
drsumitpoddar@gmail.com
Dr Rakhi Ludam
IMS & SUM Hospital
Department of Pulmonary Medicine, 4th Floor, K8 Lane 1, Kalinganagar, Bhubaneswar, Odisha 751003 Khordha ORISSA
919437258118
drrakhi01@gmail.com
Dr Zabbeuddin Imtiyazuddin Patel
Ishwar Institute of Health Care Memorial Hospital"
MH SH 16, Padegaon, Aurangabad, Maharashtra 431002 Aurangabad MAHARASHTRA
918698131415
ishwarhealthcare@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru Medical College
Ground floor Room No. Department of Pulmonary Medicine, Kala Bagh, Ajmer 305001, Rajasthan, India Ajmer RAJASTHAN
919460479888
doctorsanjiv@gmail.com
Dr Prathibha Pereira
JSS Medical College
JSS Hospital, First floor, Geriatric Dept. M.G Road, Mysuru, Karnataka-570004, India Mysore KARNATAKA
919448282506
ppatta08@gmail.com
Dr Kandregula Padmalatha
King George Hospital
KGH Down Rd, Research Room First Floor Rajendra Prasad Ward Opp KGH OP Gate, Maharani Peta, Visakhapatnam, Andhra Pradesh 530002 Visakhapatnam ANDHRA PRADESH
Medicine OPD Ground floor Building A, Room No. 244 Gate No. 2 , MGM Campus, N-6, CIDCO, Aurangabad, Maharashtra 431003 Aurangabad MAHARASHTRA
919923798702
umarazmed@gmail.com
Dr Aneesh Raj
Noorul Islam Institute of Medical Sciences (NIMS) and Research Foundation Medicity
NIMS Medicity, Aralumoodu P.O, Neyyattinkara, Thiruvanathapuram – 695123, Kerala, India Thiruvananthapuram KERALA
919539688684
draneeshraj@gmail.com
Dr Suresh Kumar
Panimalar Medical College Hospital & Research Institute
Division of Clinical Research
Panimalar Medical College Hospital and Research Institute,
Dept. General Medicine, Ground floor, Room No. 110,Varadharajapuram,
Poonamallee
Chennai,600123
Chennai TAMIL NADU
919994197191
sureshgplus@gmail.com
Dr Pravin Nagulal Soni
PCMCs PGI Yashwantrao Chavan Memorial Hospital
2nd Floor, Department of General Medicine, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018 Pune MAHARASHTRA
919822057511
drpravinsoni18@gmail.com
Dr Pawan Kumar Singh
Pt. B.D. Sharma PGIMS Rohtak
Ground floor, Room no. 16 Dept. of Pulmonary Pt. B.D. Sharma PGIMS Rohtak Medical Road, Rohtak, Haryana 124001 Rohtak HARYANA
91-8437013094
ga.ps.complete@gmail.com
Dr Ramshyam C Agarwal
Sant Dnyaneshwar Hospital (Accord Hospital)
Spine Road Plot No. 1/1 Kendriya Vihar Road, Santa Nagar, Moshi Pradhikaran, Sector Number 4, Pimpri-Chinchwad, Maharashtra 412105 Pune MAHARASHTRA
918087282022
ramshyamagarwal20@gmail.com
Dr Akash Khobragade
St. George’s Hospital
First Floor, Medical
Superintendent Office, St. George’s Hospital, P D’Mello Road, Behind GPO, Fort, Mumbai-400001
Mumbai MAHARASHTRA
Institutional Ethics Committee Govt. Medical College & Govt. General Hospital (Old RIMSGGH) Srikakulam-532001,A.P
Approved
Institutional Ethics Committee Great Eastern Medical School & Hospital, Ragolu, Srikakulam, Andhra Pradesh-532484
Approved
Institutional Ethics Committee IMS & SUM Hospital, Siksha “O†Anusandhan Deemed to be University, Bhubaneswar Odisha 751003
Approved
Institutional Ethics Committee King George Hospital, Maharani Peta, Visakhapatnam, Andhra Pradesh 530002
Approved
Institutional Ethics Committee Kurnool Medical College/Govt. Medical College, Bhudawarapet Bharath Petroleum, Kisan Ghat Rd, Kurnool, Andhra Pradesh 518002
Approved
Institutional Ethics Committee Om -Sai Onco, R.S No. 457/10 C, Dr. Lad Colony, Sugar Mill Corner, Main Road, Kasaba Bawade, Kolhapur – 416 006
Approved
Institutional Ethics Committee PCMCS PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar, Near D.Y. Patil Medical College Vallabhnagar, Near Fire Brigade Station, Pimpri, Pune-411018, Maharashtra
Approved
Institutional Ethics Committee Sai Sneh Hospital & Diagnostic Centre, Opp PMT Bus stop, Katraj, Pune 411046
Institutional Ethics Committee Vijay Vallabh Hospital, 423, Tirupati Nagar Phase 1 Bolinj Virar (W) 401 303, Family Care Hospital Mira Road 401107
Approved
Institutional Ethics Committee, HP Poddar Memorial Clinic and Nursing Home 56H, Dr. Suresh Chandra Banerjee Road, Beleghata, Kolkata -700010 West Bengal
Approved
Institutional Ethics Committee, JSS Hospital, M.G Road, Mysuru, Karnataka-570004, India
Approved
Institutional Ethics Committee, Kala Bagh, Ajmer 305001, Rajasthan, India
Approved
Institutional Ethics Committee, KLES Dr. Prabhakar Kore Hospital & MRC, Basava Circle, Chikodi, Nehru Nagar, Belgaum, Karnataka 590010
Institutional Ethics Committee, Noorul Islam Institute of Medical Sciences and Research Foundation, NIMS Medcity, Aralumoodu PO, Neyyattinkara, Aralumoodu Thiruvananthapuram, Kerala-695123
Approved
Institutional Ethics Committee, PGIMS UHS Rohtak Biomedical Research Ethics Committee Pt. B.D. Sharma, PGIMS, UHS, Rohtak, Haryana-124001, India
Approved
Institutional Ethics Committee, St George’s Hospital Grant Government Medical College & Sir JJ Hospital, Department of Pharmacology, Opposite Central Canteen, Byculla, Mumbai 400008, India
Approved
Institutional Human Ethics Committee (PMCHRI-IHEC), Panimalar Medical College Hospital & Research Institute Varadharajapuram, Poonamallee Chennai,600123
Approved
Kakatiya institutional ethics committee kakatiya medical college Svp road rangampet street warangal Urban Warangal Urban Telangana - 506007
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Molnupiravir 800 mg (4x200 mg or 2x400 mg) capsules twice a day (BID) for 5 days plus standard of care (SOC)
Patients will be instructed to to take Molnupiravir 800 mg capsules twice a day (morning and evening) orally one hour before food intake with a glass of water for 5 days
Comparator Agent
Standard of Care (SOC) only
Standard of Care (SOC) only
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements.
2. Male or female patients between 18 and 60 years of age (both inclusive).
3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected ≤5 days prior to randomization) Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization.
4. Patients with mild COVID-19 and have following symptoms and signs prior to randomization.
Mild: Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia.
5. Patients who are able to consume oral medications.
6. Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
Refrain from donating sperm; and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception.
7. Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.
ExclusionCriteria
Details
1. 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.
2. Uncontrolled comorbid medical conditions.
3. Patient is currently hospitalized or is expected to need hospitalization
for COVID-19 within 48 hours of randomization.
4. Patient is on dialysis or has reduced estimated glomerular filtration rate (73m2eGFR) <30 mL/min/1 by the Modification of Diet in Renal Disease (MDRD) equation.
5. 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.
6. 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.
7. If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
8. Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis.
9. Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigator’s discretion.
10. A baseline heart rate of < 60 beats per minute at rest.
11. 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
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of Molnupiravir to standard of care in confirmed RT-PCR positive patients with Mild COVID-19
Day 1 to Day 5
RT-PCR will be evaluated on screening, end of treatment day (plus 1) or at the time of early discontinuation.
Note: If RT-PCR test is found to be positive for Day 5 (plus 1) sample, the test may be repeated on Day 10 and on Day 14, if it was positive on Day 10
Post treatment follow-up Day 10, Day 14(plus 1 Day), 28 Day ( plus 1 Day)
Rate of hospitalization from randomization up to day 14
Secondary Outcome
Outcome
TimePoints
Incidence and severity of TEAEs (clinical and laboratory)
During the study.
Proportion of patients discontinued the study drug due to adverse events
During the study
Rate of hospitalization
Randomization up to Day 28
Proportion of patients with clinical improvement
End of treatment, Day 10 and 14
Time to clinical improvement
from randomization up to Day 14
Mortality rate
Day 14
Mortality Rate.
At day 28
Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab
End of treatment, Day 10 and Day 15
Change in SARSCoV-2 viral load (Cycle Threshold (CT) value of RT-PCR test)
From Baseline to end of treatment
Target Sample Size
Total Sample Size="1218" Sample Size from India="1218" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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, parallel, multicenter Phase III study. The purpose of this study to estimate Molnupiravir efficacy and safety in COVID-19 patients.
In study duration: Total expected study duration will be approximately 28 days consisting of: Screening period: -3 days (-72 hours) prior to randomization.
Treatment period: 5 days
End of treatment assessment: Day 5 (+1) or at the time of early discontinuation
Post treatment follow-up: Day 10, Day 14 (+1) and Day 28 (+1)
Note: If RT-PCR test is found to be positive for Day 5(+1) sample, the test may be repeated further at Day 10 and on Day 14 (+1), if found positive on Day 10.
Total study participation duration for all the patients will till Day 28.