CTRI Number |
CTRI/2021/08/035424 [Registered on: 04/08/2021] Trial Registered Prospectively |
Last Modified On: |
03/08/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
Study to evaluate the efficacy and safety of Molnupiravir capsules Compare with the with Standard of Care Medications Care alone in patients who are suffering with Moderate 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 Moderate COVID-19 disease |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
CR217-21 |
Protocol Number |
Version 2.0 Dated 08 Jun 2021 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Subhra Lahiri |
Address |
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
Hyderabad TELANGANA 500049 India |
Phone |
8886221089 |
Fax |
40408060 |
Email |
Subhra.L@axisclinicals.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Subhra Lahiri |
Address |
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
Hyderabad TELANGANA 500049 India |
Phone |
8886221089 |
Fax |
40408060 |
Email |
Subhra.L@axisclinicals.com |
|
Details Contact Person Public Query
|
Name |
Dr Subhra Lahiri |
Address |
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
Hyderabad TELANGANA 500049 India |
Phone |
8886221089 |
Fax |
40408060 |
Email |
Subhra.L@axisclinicals.com |
|
Source of Monetary or Material Support
Modification(s)
|
APL Research Centre-II,
Aurobindo Pharma Limited,
Sy No. 71&72,
Indrakaran (V), Sangareddy (M),
Medak Dist-502329, Telangana, India.
|
|
Primary Sponsor
|
Name |
Aurobindo Pharma Limited |
Address |
Aurobindo Pharma Limited
Sy No71&72Indrakaran (V)SangareddyM
Medak Dist 50 2329Telangana, India |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 6 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Pramod Sonba Atole |
Baramati Hospitals Pvt.Ltd |
Behind Kavivarya Moropant Natyamandir,
Ring Road, Baramati-413102
Pune |
9970997767
drpramodatole@gmail.com |
DrSoumik Chowdhury |
Health Point Hospital |
21, Prannath Pandit Street, Opposite Lansdown Padmapukur, Kolkata -700025 Kolkata |
9432164842
shoumikchowdhary0@gmail.com |
Dr Vaibhav Lotke |
Pulse Multispeciality Hospital |
Vishwa Arcade, Near Bombay Bangalore Highway,
Narhe, Pune, 411041
Maharashtra, India
Pune |
8552003274
drlotke.pulse@gmail.com |
Dr Vijaykumar Barge |
RCSM Govt. Medical College and CPR Hospital |
Dasara Chowk, Bhausingji Road, Town HallKolhapur-416012 Kolhapur |
9011066766
drvijaybarge12@gmail.com |
Dr A Venkatshwar Rao |
St Theresas Hospital |
Sanathnagar, Hyderabad-500018 Hyderabad |
9440040662
drvenkateshwarraoavula@gmail.com |
Dr Abhishek Mahadev Karmalkar |
Vedant Multispeciality Hospital |
Sambhaji Nagar, Chinchwad, Pune 411019
Maharashtra
Pune |
9850337271
dr.karmalkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 6 |
Name of Committee |
Approval Status |
Ethics committee of Baramati hospital |
Approved |
Ethics committee of Pulse Multispecialty hospital |
Approved |
Ethics committee St.Theresa’s hospital |
Approved |
Health Point Ethics Committee |
Approved |
IEC of Vedant multispecialty hospital |
Approved |
Kolhapur Institutional Ethics committee 2( RCSMGMCIEC2) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Acute upper respiratory infection,unspecified |
Patients |
Coronavirus as the cause of diseases classified elsewhere |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
Molnupiravir capsules |
05 Days treatment. 1600 mgs/twice a day/Oral |
Comparator Agent |
Standard of Care Therapy |
Standard of Care Therapy as per the Institution Practice and Based on Patient condition |
|
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 presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization.
a. Respiratory rate ≥ 24/min, breathlessness
b. SpO2: 90% to ≤ 93% on room air
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 |
Inclusion Criteria:
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 presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization.
a. Respiratory rate ≥ 24/min, breathlessness
b. SpO2: 90% to ≤ 93% on room air
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)
Exclusion Criteria:
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 pulse rate < 50 beats per minute at rest at the time of screening and randomization.
5. Patient with severe COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO).
6. 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.
7. Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization.
8. Patients with AIDS-defining illness in the past 6 months.
9. 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.
10. Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation.
11. Patients with Absolute Neutrophil Count (ANC) < 500 mm3.
12. Patients currently administering immunosuppressive treatments within 30 days of prior to randomization.
13. Female patients who are pregnant and/ or breast feeding.
14. 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
|
Stratified block randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Proportion of patients with clinical improvement at Day 14.
Clinical improvement is defined as 2-point decrease in clinical progression scale as recommended by WHO.
|
Day 28 |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
• Proportion of patients with clinical improvement at Day 28.
• Time to clinical improvement from randomization up to 28 days.
• Mortality rate at Day 28.
• Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab at the end of treatment, Day 14 and Day 28.
• Change in SARS CoV-2 viral load (Cycle Threshold (CT) value of RT-PCR test) from baseline to end of the treatment, Day 14 and Day 28.
|
Day 28
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="100" Sample Size from India="100" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
10/08/2021 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
No |
Brief Summary
|
This is a phase 3, prospective, open-label,
randomized, multicentre, a parallel study in patients with Moderate COVID-19 disease.
This study will be conducted in two parts. In part 1, the study will be
conducted on 100 patients. Part 2 of this study will be continued to complete
the enrollment of remaining patients to achieve the randomization of 1284 patients
considering two parts. The total duration of study for each patient will be
approximately 5 weeks including a screening period. This study will be conducted
in approximately 20 sites across India. |