| CTRI Number |
CTRI/2021/07/034588 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
03/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with mild COVID-19 disease |
|
Scientific Title of Study
|
A Phase 3 Prospective Open Label, Randomized Multicenter Parallel Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with mild COVID-19 disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR216-21 Version 2.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhra Lahiri |
| Designation |
Vice President |
| Affiliation |
AXIS Clinicals Ltd |
| Address |
AXIS Clinicals Ltd
1-121/1 Miyapu
AXIS Clinicals Ltd
1-121/1 Miyapur Hyderabad500049
Telangana INDIA
Medchal
TELANGANA
500049
India |
| Phone |
8886221089 |
| Fax |
40408060 |
| Email |
Subhra.L@axisclinicals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhra Lahiri |
| Designation |
Vice President |
| Affiliation |
AXIS Clinicals Ltd |
| Address |
AXIS Clinicals Ltd
1-121/1 Miyapu
AXIS Clinicals Ltd
1-121/1 Miyapur Hyderabad500049
Telangana INDIA
TELANGANA
500049
India |
| Phone |
8886221089 |
| Fax |
40408060 |
| Email |
Subhra.L@axisclinicals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhra Lahiri |
| Designation |
Vice President |
| Affiliation |
AXIS Clinicals Ltd |
| Address |
AXIS Clinicals Ltd
1-121/1 Miyapu
AXIS Clinicals Ltd
1-121/1 Miyapur Hyderabad500049
Telangana INDIA
TELANGANA
500049
India |
| Phone |
8886221089 |
| Fax |
40408060 |
| Email |
Subhra.L@axisclinicals.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aurobindo Pharma Limited |
| Address |
APL Research Centre-II,
Aurobindo Pharma Limited,
Sy No.71&72Indrakaran VSangareddy M Medak Dist-502329, Telangana, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPankaj Bharatbhai Vyas |
AnandSurgicalHospitalPrivateLimited |
MemcoCrossRoadNarodaRoad Ahmedabad382345
Ahmadabad
GUJARAT |
9726630128
nirmit.clinicalreserach@gmail.com |
| Dr Smit Shah |
DHS Multispecialty Hospital |
Vastrapur
Lake –Himalaya mall link Road,Vastrapur,
Ahmedabad-380054
Ahmadabad
GUJARAT |
7405310006
contactsmit@gmail.com |
| Dr Gofne Sandip Krishnrao |
District Civil Hospital |
District Civil Hospital Department of Medicine
Near Airport Jalna Road, Chikalthana
Aurangabad-431007
Maharashtra.
Aurangabad
MAHARASHTRA |
9579268780
ankesh@dphsindia.com |
| Dr Devineni Sai Sahul |
Dr. Devineni Sai Sahul |
Sri Sri Holistic Hospitals MIG113114Rd NumberKukatpally Housing Board ColonyKukatpally HyderabadTelangana 500072Â Â
Hyderabad
TELANGANA |
9642099111
drsaisahul@gmail.com |
| Dr Vaibhav Lotake |
Dr. Vaibhav Lotake, Pulse Multispeciality Hospital |
Vishwa Arcade, Near Bombay Bangalore Highway,
Narhe, Pune, 411041
Pune
MAHARASHTRA |
8552003274
sanjivanee.clinithink@gmail.com |
| Dr Uppe Abhay Gangadhar |
Dr.DY.Patil Hospital Research Centre |
Department Of Pulmonary MedicineOPD691stFloorDr D.Y.Patil Hospital ResearchcentreSector5,NerulNaviMumai400706Maharashtra India
Mumbai
MAHARASHTRA |
9769319554
abhayuppe@yahoo.com |
| DrSoumik Chowdhury |
Health Point Hospital |
21, Prannath Pandit Street, Opposite Lansdown Padmapukur
Kolkata
WEST BENGAL |
9432164842
nilendu@indorivclinical.com |
| Dr Surender Katta |
Induss Hospital |
Opp. Kothapet Fruit Market,
Near Gaddiannaram Municipal Office
Krishnaveni Nager Colony
Kothapet
Hyderabad
TELANGANA |
9700565999
drksrkatta@gmail.com |
| DrMicky Patel |
Lotus Multi Speciality Hospital |
Lotus Multi Speciality Hospital,
N Block Krupa Society,
Beside Swastik School,
Motera Stadium Road,Motera,
Ahmedabad-380005
Ahmadabad
GUJARAT |
9909007305
hirenshukla89@gmail.com |
| Dr Sahebrao Toke |
Ojas Multispeciality Hospital |
D.Y Patil College Road, Bhondave Chowk, Ravet
Pune- 412101
Pune
MAHARASHTRA |
9503553685
dr.sahebrao@gmail.com |
| DrJayesh Ambaliya |
Pagarav Hospital & ICU |
Plot no.St,
2/1, Nr. Circle, Opp.SBI, Sector -23.
Gandhinagar ,382023
Gujarat, India.
Gandhinagar
GUJARAT |
9998310174
jayeshambaliya05.ja@gmail.com |
| DrParthasarthi Karmakar |
RGKAR MedicalColleg andHospital |
1KhudiramBoseSaraniKolkata 700004West Bengal
Kolkata
WEST BENGAL |
7679634227
clin.crc.rtdrgkar@gmail.com |
| Dr Prabhakar K |
ST. Theresa’s Hospital |
(A Unit of St. Thereas’s Convert Society)
PAN: AAATS7437D
Sanathnager Hyderabad-500018
Hyderabad
TELANGANA |
9052734387
cpdstth@gmail.com |
| DrKhobragade Akash Ashokkumar |
StGeorges Hospital |
StGeorgesHospitalSirJJGroup ofHospitalsMelloRoadMumbai 400008
Mumbai
MAHARASHTRA |
9702658822
drakashk.research@gmail.com |
| Dr Lily Rodrigues |
Surakshaka Diabetic Center Private Limited |
MIG 218, NH65, KPHB Phase1Â Kukatpally
Hyderabad
TELANGANA |
9704799955
surakshakacrr@gmail.com |
| Dr Nilesh Patil |
Vedant Multispeciality Hospital |
Vedant Multispeciality Hospital,
Sambhaji Nagar Pune 411019
Maharashtra.
Pune
MAHARASHTRA |
7720005912
neeleshp84@gmail.com |
| Dr Dhaiwat Shukla |
VS General Hospital, |
Elisbridge, Ahmedabad
Ahmadabad
GUJARAT |
980024107
dhruval_doshi@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Amena Kathun Hospital Ethics Committee |
Approved |
| Amena khatun hospital Ethics committee |
Approved |
| Ethics committee of Pulse Multispecialty hospital |
Approved |
| Ethics committee St. Theresas hospital |
Approved |
| Ethics committee St. Theresas hospital |
Approved |
| Ethics Committeeajanta Superspeciality hospital |
Approved |
| Health Point Ethics Committee |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional ethics committee Vedant multispeciality hospital |
Approved |
| Institutional Ethics committeeDY |
Approved |
| Kanoria Ethics Committee |
Approved |
| Lotus Ethics Committee |
Approved |
| ojas Multispeciality Hospital Ethics Committee |
Approved |
| Pagarav Ethics Committee |
Approved |
| sree Ramachandra health services PVT.LTD |
Approved |
| Suraksha Ethics committee |
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 |
Molnupiravir pluse standard of care and standard of care alone As per ICMR.
Duration of Treatment : 5 days oral twice daily (800mg) |
| Comparator Agent |
Standard of care therapy |
standard of care therapy will be given to the subjects as per the institution practice
Duration of Treatment : 5days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and/or female patients aged ≥ 18 and ≤ 60 years of age (both inclusive).
2.Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent.
3.Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization.
4.Patients with uncomplicated upper respiratory tract symptoms may have one of the symptoms of fever, cough, sore throat, nasal congestion, malaise, headache or any other signs and COVID-19 symptoms without any evidence of breathlessness or hypoxia (normal saturation) within 5 days prior to the randomization.
5.Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on).
6.Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit.
7.Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization.
Medically acceptable forms of contraceptive include:
a.Hormonal contraceptives (at least 1 month before screening visit)
b.Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide)
c.Intrauterine device (IUD)
|
|
| ExclusionCriteria |
| Details |
1.Patients with known hypersensitivity to any of the excipients of the study medication or to any other similar class of drugs.
2.Patients who participated in any other clinical trial of an experimental treatment for COVID-19 within 90 days prior to randomization.
3.Patients infected post vaccination of either 1st or 2nd dose.
4.Patients with one of the following symptoms at the time of screening.
a. Respiratory rate ≥ 24/min, breathlessness
b. SpO2: ≤ 93% on room air
5.Patients with pulse rate < 50 beats per minute at rest at the time of screening and randomization
6.Patients are currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization.
7.Patients have 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.
8.Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization.
9.Patients with AIDS-defining illness in the past 6 months.
10.Patients with uncontrolled co-morbid conditions such as hypertension, diabetes, cardiovascular disease, chronic lung/ liver/ kidney disease, cerebro-vascular disease as per the investigator’s discretion.
11.Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation.
12. Patients with Absolute Neutrophil Count (ANC) < 500 mm3.
13.Patients currently administering immunosuppressive treatments within 30 days of prior to randomization or systemic corticosteroids.
14.Female patients who are pregnant and/ or breast feeding.
15.Patients who have any medical condition(s) or has any medical condition(s) which would likely interfere with the conduct or interpretation of the study as per the investigator’s discretion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of hospitalization of patients from randomization up to Day 14.
Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate ≥ 24/ minute and SpO2≤93% in room air requiring oxygen supplementation. |
Rate of hospitalization of patients from randomization up to Day 14.
Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate ≥ 24/ minute and SpO2≤93% in room air requiring oxygen supplementation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Rate of hospitalization of patients from randomization up to Day 28.
• Proportion of patients with clinical improvement at end of treatment, Days 10 and 14.
|
28 days.
Day 10 and 14. |
|
|
Target Sample Size
|
Total Sample Size="1220"
Sample Size from India="1220"
Final Enrollment numbers achieved (Total)= "1220"
Final Enrollment numbers achieved (India)="1220" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2021 |
| Date of Study Completion (India) |
18/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a phase 3, prospective, open label, randomised, multicentre, parallel study in patients with mild COVID-19 disease. This study will be conducted in approximately 20 sites across India. The total duration of study for each patient will be approximately 5 weeks including screening period. |