CTRI/2021/12/038637 [Registered on: 15/12/2021] Trial Registered Prospectively
Last Modified On:
13/03/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Clinical Trial to study the safety and efficacy of a drug, DESREM LQTM in patients
with Moderate to Severe Covid-19.
Scientific Title of Study
A post approval for restricted use under emergency situation study to evaluate the Safety and Efficacy of DESREM LQTM in patients with Moderate to Severe Covid-19 in Indian population.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
REMD-IJS-4001, Version 1.2 Dated 13 Aug 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jayashri Krishnan
Designation
Director Operations
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
Faridabad HARYANA 121003 India
Phone
9771407484
Fax
91-129-6613520
Email
jayashri.krishnan@jssresearch.com
Details of Contact Person Scientific Query
Name
Dr Sonika Newar
Designation
General Manager – Medical Monitoring and Safety
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
Faridabad HARYANA 121003 India
Phone
8800799887
Fax
91-129-6613520
Email
sonika.newar@jssresearch.com
Details of Contact Person Public Query
Name
Dr Jayashri Krishnan
Designation
Director Operations
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
Faridabad HARYANA 121003 India
Phone
9771407484
Fax
91-129-6613520
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Mylan Laboratories Limited
Plot No. 564/A/22,
Road No. 92, Jubilee Hills,
Hyderabad – 500 096, Telangana, India.
Primary Sponsor
Name
Mylan Laboratories Limited
Address
Plot No. 564/A/22,
Road No. 92, Jubilee Hills,
Hyderabad – 500 096.
Telangana, India.
Guntur Medical College and Government General Hospital,
Room No. – 103
Floor No. –
Department –General Medicine
Address – Guntur Medical College and
Government General Hospital, GUNTUR - 522 034. ANDHRA PRADESH Guntur ANDHRA PRADESH
9848233703
sudhahealer@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru Medical College
Room No. 99, Ground Floor, OPD Building, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer – 305 001. Rajasthan, India Ajmer RAJASTHAN
9460479888
doctorsanjiv@gmail.com
Dr Anand M K
Jubilee Mission Medical College And Research Institute
Room No 633 B Block, 5th Floor, Jubilee Mission Medical College & Research Institute, Bishop Alappat Road, Thrissur-680 005, Kerala, India. Thrissur KERALA
9645276743
dranandmk86@gmail.Com
Dr Abraham P George
Lourdes Hospital
Department of General Medicine, OP Block, Ground Floor, Room No. 89,
Lourdes Hospital, Ernakulam, Kochi- 682 012, Kerala, India.
Ernakulam KERALA
9645276743
drabrahamgeorge02@gmail.com
Dr V Chandrasekhar
Mahatma Gandhi Memorial Hospital
Department of Medicine, Ground Floor, Mahatma Gandhi Memorial Hospital, Sherpura, Warangal, Telangana 506002. India. Warangal TELANGANA
9346950050
drchandrasekhar.krcwgl@gmail.com
Dr Mohammed Mirvaz Zulfikar
Malabar Medical College Hospital And Research Centre
Clinical Trial Unit,
Pharmacology Department,
4th Floor, Mmc Building,
Malabar Medical College Hospital And Research Centre, P.O. Madakkalur, Ulliyer P.O., Atholi, Kozhikode - 673 323. Kozhikode-Atholi. Kozhikode KERALA
0496-2701800
mohammedmzulfikar@gmail.com
Dr Rajesh Nair
Mar Augustine Golden Jubilee Hospital
Clinical Research Room, Ground Floor,
Near Fever Clinic,
Mar Augustine Golden Jubilee Hospital,
Mookkannoor P.O., Angamaly, Ernakulam – 683 577.
Kerala, India.
Ernakulam KERALA
9400657073
drnairrajesh@gmail.com
Dr Reema Kashiva
Noble Hospital Private Limited
Room No. 08, Ground Floor, Department of Medicine, Noble Hospital Private Limited, No. 153, Moagarpatta city road, Hadapsar, Pune, Maharashtra – 411 013. Pune MAHARASHTRA
9922618286
reemakashiva@gmail.com
Dr Pravin Nagulal Soni
PCMCs PGI Yashwantrao Chavan Memorial (YCM) Hospital
2nd Floor, Department of General Medicine, PCMC’s PGI Yashwantrao Chavan Memorial (YCM) Hospital, YCM Hospital Road, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra - 411 018. Pune MAHARASHTRA
1st Floor, Corporate Building, CRF Department, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai – 602 105. Tamil Nadu, India. Chennai TAMIL NADU
9710071284
drkannancrf@gmail.com
Dr Akash Khobragade
St. George’s Hospital
Medical Superintendents office, 1st Floor, St. George’s Hospital, Grant Government Medical College & Sir JJ Group of Hospitals, P D’Mello Road, CST, Mumbai 400001, Maharashtra, India. Mumbai MAHARASHTRA
9702658822
drakashk.jj@gmail.com
Dr Changalva Premdeep
Vijaya Super Speciality Hospital
Room No. 07, Ground Floor, OPD Main Block, Vijaya Super Speciality Hospital, 16-II/41 A, Raghava Cine Complex Road, Pogathota, Nellore, Andhra Pradesh – 524 001. India. Nellore ANDHRA PRADESH
Institutional Ethics Committee Lourdes Hospital Ernakulam Pachalam, Kerala, India Ernakulam, Kerala-682012 India.
Approved
Institutional Ethics Committee Jubilee Mission Medical College & Research Institute, Bishop Alappat Road, Thrissur-680 005, Kerala, India.
Approved
Institutional Ethics Committee Malabar Medical College Hospital And Research Centre, P.O. Madakkalur, Ulliyer P.O., Atholi, Kozhikode - 673 323. Kozhikode-Atholi.
Approved
Institutional Ethics Committee Mar Augustine Golden Jubilee Hospital, Mookkannoor P.O., Angamaly, Ernakulam – 683 577. Kerala, India.
Approved
Institutional Ethics Committee Noble Hospital Private Limited, Room No. 08, Ground Floor, Department of Medicine, No. 153, Moagarpatta city road, Hadapsar, Pune, Maharashtra – 411 013.
Submittted/Under Review
Institutional Ethics Committee Yashwantrao Chavan Memorial (Ycm) Hospital, Ycm Hospital Road, Sant Tukaram Nagar, Near D.Y. Patil Medical College, Pimpri Colony, Pune, Maharashtra - 411 018.
Submittted/Under Review
Institutional Ethics Committee, Basement, Medical College Building, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer – 305 001. Rajasthan, India.
Approved
INSTITUTIONAL ETHICS COMMITTEE, Grant Govt Medical College, JJ Road, JJ Hospital compound, Mumbai Central, Mumbai, Maharashtra-400008, India.
Approved
Institutional Ethics Committee-Guntur medical college and govt general hospital
Kakatiya Institutional Ethics Committee, Kakatiya Medical College, SVP Road Rangampet StreeT, Warangal Urban Telangana–506007 India.
Approved
Saveetha Medical College and Hospital – Institutional Ethics Committee (SMCH_IEC), Saveetha Nagar, Thandalam, Chennai–602 105, Tamil Nadu, India
Approved
Vijaya Ethics Committee, Room No.: 04/A, Fourth Floor, Surgical Main Block, Vijaya Super Speciality Hospital, 16-II/41 A, Raghava Cine Complex Road, Pogathota, Nellore, Andhra Pradesh–524 001, India.
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
DESREM LQ TM Remdesivir Injection 100mg/20 mL
Route – Intravenous only
Dose – Day 1 started with 200 mg intravenous infusion over 30 to 120 minutes followed by Day 2,3,4, & 5 - maintenance dose of 100 mg daily intravenous infusion over 30 to 120 minutes.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Confirmed Covid-19 infection
2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures
3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
4. Male or non-pregnant female adult ≥ 18 years of age at time of enrollment
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:
• PCR positive in sample collected < 72 hours prior to enrollment; OR
• PCR positive in sample collected ≥ 72 hours prior to enrollment, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
6. Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare, Government of India) Clinical Guidance For Management of Adult COVID-19 Patients (Dated 22 Apr 2021): Clinical severity of moderate to severe.
7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28
8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or any other indications through Day 28
ExclusionCriteria
Details
1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 3 times the upper limit of normal
2. Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration)
3. Pregnancy or breast feeding
4. Subjects with <40 kg body weight
5. Subjects who are on mechanical ventilation or ECMO (Extracorporeal membrane oxygenation)
6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
7. Hypersensitivity to any ingredient of DESREM LQTM
8. Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study
9. Patients who are on or would require any other investigational therapies/products for the treatment of Covid-19 disease.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence of treatment emergent AEs and SAEs
Day 1 to Day 28
Secondary Outcome
Outcome
TimePoints
Mortality
Percentage of patients with atleast Two point improvement from baseline in clinical status on the 8 Point ordinal scale
Time to Recovery
Time to SpO2 94 % on room air
Time to first fever normalization
Day 28
Day 14
Day 14
Day 14
Day 14
Target Sample Size
Total Sample Size="202" Sample Size from India="202" 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 will be a post approval for restricted use under emergency situation study, interventional, prospective, multi-center, open-label study to evaluate the safety and efficacy of DESREM LQTMin Indian patients with moderate to severe Covid-19 disease.
Primary objective is to assess the Safety and Tolerability of DESREM LQ TM in patients with moderate to severe Covid 19, by determining incidence of Adverse events during
DESREM LQ TMtreatment and upto Day 28 from enrollment.
Secondary objective is to determine mortality at day 28