| CTRI Number |
CTRI/2021/05/033864 [Registered on: 28/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19) |
|
Scientific Title of Study
|
A Prospective, Randomized, Parallell, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MOLN/MSN/P3-M2/2021 version 1.0 dated 12-May-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Antaryami Maharana |
| Designation |
Medical Monitor |
| Affiliation |
Abiogenesis Clinpharm PVT LTD |
| Address |
Abiogenesis Clinpharm PVT LTD, 2nd Floor Plot No. 69,
8-2-248/1/7/69, Nagarjuna Hills, Punjagutta, Hyderabad-500082,
Telangana,India
Hyderabad
TELANGANA
500082
India
Hyderabad
TELANGANA
500082
India |
| Phone |
7702186021 |
| Fax |
|
| Email |
antaryami@abiogenesisclinpharm.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Antaryami Maharana |
| Designation |
Medical Monitor |
| Affiliation |
Abiogenesis Clinpharm PVT LTD |
| Address |
Abiogenesis Clinpharm PVT LTD, 2nd Floor Plot No. 69,
8-2-248/1/7/69, Nagarjuna Hills, Punjagutta, Hyderabad-500082,
Telangana,India
Hyderabad
TELANGANA
500082
India
Hyderabad
TELANGANA
500082
India |
| Phone |
7702186021 |
| Fax |
|
| Email |
antaryami@abiogenesisclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
K Ravinder Reddy |
| Designation |
Indian Regulatory Affairs -GM |
| Affiliation |
MSN Group of Companies |
| Address |
MSN Group of Companies,
MSN House, Plot No: C-24,
Industrial Estate, Sanathnagar,
Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
04030438712 |
| Fax |
|
| Email |
krreddy@msnlabs.com |
|
|
Source of Monetary or Material Support
|
| MSN Laboratories Private Limited |
|
|
Primary Sponsor
|
| Name |
MSN Laboratories Private Limited |
| Address |
MSN Laboratories Private Limited.,
MSN House : Plot No: C-24, Industrial Estate, Sanathnagar, Hyderabad -500 018, Telangana, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit jain |
DIVINE Multispecialty Hospital and Cancer Centre |
Emergency department, Ground floor,Divine Multispecialty Hospital and cancer center, 102/2, Main Jagatpur Road, Near street No.14, Wazirabad. Delhi 110084
North
DELHI |
9212410444
rohitjain4783@gmail.com |
| Dr Sunil Nayak |
Govt. Medical College Govt. General Hospital |
Department of General Medicine, Room no. 13, 2nd floor, Govt. Medical College Govt. General Hospital Hudco Colony, Balaga, Srikakulam 532001
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaikggh@gmail.com |
| Dr Anshul Jain |
MLB Medical college |
Department of Anesthesia, PMSSY Block, COVID Hospital. MLB Medical College. Jhansi-284128
Jhansi
UTTAR PRADESH |
9411685406
dranshuljain81@gmail.com |
| Dr Vijaykumar Bhagwan Barge |
RCSMGMC and CPR General Hospital |
Department of medicine, Ground floor, Room no. 7, Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur, Dasara Chowk, Townhall, Bhausingji Road, Maharashtra- 416012
Kolhapur
MAHARASHTRA |
9011066766
drvijaybarge12@gmail.com |
| Dr AV Rao |
St Theresa Hospital |
Department-General medicine, Division- General Medicine, Room No-03. Erragadda Main Rd, opposite Erragadda Rythu Bazar, Jet Colony, Sanath Nagar, Hyderabad
Hyderabad
TELANGANA |
9440040662
drvenkateshwarraoavula@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, MLB Medical College |
Approved |
| Ethics Committee, St Theresa Hospital |
Approved |
| Institutional Ethics Committee for Sehgal Nursing Home |
Approved |
| Institutional Ethics Committee Government Medical College and Govt General Hospital |
Approved |
| RCSMGMCIEC2,RCSMGMC and CPR Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 Clinical Guidance for Management of Adult COVID-19 by ICMR |
|
|
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 age (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 RT-PCR (within 48 hours prior to randomization).
4.Subjects having moderate COVID-19 as per MoH & FW guidelines on “Clinical Management Protocol: COVID-19†as updated from time to time.
o Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 ≤93% (range 90-93%) on room air, respiratory rate more or equal to 24 per minute. (Time for symptom onset and baseline should be no more than 10 days).
|
|
| ExclusionCriteria |
| Details |
1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient.
2.Subjects with severe COVID-19: severe pneumonia. with clinical signs of pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90%.
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.Subjects with oxygen saturation (SPO2) below 90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg.
5.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.
6.Pregnant or breast-feeding subjects will be excluded.
7.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).
8.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening.
9.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.
10.Subject has a history of alcohol or drug abuse in the previous 6 months.
11.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
12.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
13.Anticipated transfer to another hospital which is not a study site within 72 hours.
14.Participated in any other clinical trial or taken investigational drug within 1 month.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with clinical improvement at Day fourteen
|
Proportion of patients with clinical improvement at Day fourteen
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with clinical improvement |
Day 28 |
| Mortality rate |
Day 28 |
| Rate of SARS CoV2 RT-PCR negativity in nasopharyngeal swab and/or oropharyngeal swab |
End of treatment, Day 14 and Day 28 |
| Change in SARS CoV2 viral load (Cycle Threshold (CT) value of RT-PCR test) |
From baseline to end of treatment, Day 14 and Day 28 |
| Incidence and severity of TEAEs (clinical and laboratory) |
All the visits |
| Proportion of patients discontinued the study drug due to adverse event |
All the visits |
|
|
Target Sample Size
|
Total Sample Size="1282"
Sample Size from India="1282"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of the study is to evaluate the
efficacy of Molnupiravir Capsule compared to standard of care in confirmed
RT-PCR positive patients with moderate Coronavirus Disease of 2019 (COVID-19).
Primary Objective:
To evaluate the efficacy of
Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive
patients with moderate Coronavirus Disease of 2019 (COVID-19).
Secondary Objective:
To evaluate the safety of
Molnupiravir compared to standard of care in confirmed RT-PCR positive patients
with moderate Coronavirus Disease of 2019 (COVID-19).
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.
|