CTRI/2022/02/040649 [Registered on: 25/02/2022] Trial Registered Prospectively
Last Modified On:
02/03/2023
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 TM 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 Efficacy and Safety of DESREMTM in Patients with Moderate to Severe Covid-19 in Indian Population.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
REMD-ILS-4001 Version 2.0 Dated 29 Sep 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
09771407484
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
08800799887
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
09771407484
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.
DEC-Health Care Center, 16/2/219, Pogathota, Nellore, Andhra Pradesh–524001, India. Nellore ANDHRA PRADESH
9700487720
manojkumarmddec@gmail.com
Dr K Sudhakar
Government General Hospital
Government General Hospital, Department of General Medicine, IP Building, Main Road Guntur, Andhra Pradesh-522004 India. Guntur ANDHRA PRADESH
9848233703
sudhahealer@gmail.com
Dr Anand MK
Jubilee Mission Medical College & Research Institute
St. Thomas Block, Floor no.02, Room No.1210, Bishop Alappat Road, Thrissur-680005, Kerala, India. Thrissur KERALA
9645276743
dranandmk86@gmail.com
Dr Kamminana Geeta Priyadarsini
King George Hospital
Clinical research room, Rajendra Prasad ward, King George hospital, Maharanipeta, Visakhapatnam – 530002, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9989364536
drkgpriyadarsiniresearch@gmail.com
Dr Chandrashekar Valupadas
Mahatma Gandhi Memorial Hospital
1st Floor, Clinical Research Department, Mahatma Gandhi Memorial Hospital, Sherpura, Warangal Urban- 506002, Telangana. Warangal TELANGANA
9346950050
drchandrasekhar.krcwgl@gmail.com
Dr E Caezar Ennis
NIMS Medicity, Trivandrum
2nd Floor, Room No:204
NIMS Medicity,
Aralummodu, Neyyattinkara, Trivandrum-695123, Kerala, India Thiruvananthapuram KERALA
9778425559
drceaserennis12@gmail.com
Dr Aparna N Kodre
Noble Hospital Pvt. Ltd.
Basement Floor, Room No: 5 & 6, Noble Hospital, 153, Road, Magarpatta, Hadapsar, Pune, Maharashtra 411013, India. Pune MAHARASHTRA
9850136436
draparnankodre@gmail.com
Dr Pravin Nagulal Soni
PCMC’s PGI Yashwantrao Chavan Memorial Hospital
2nd Floor, Department of General Medicine, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018 Pune MAHARASHTRA
9822057511
drpravinsoni18@gmail.com
Dr Kannan Rajendran
Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam, Chennai-602 105, Tamil Nadu, India. Kancheepuram TAMIL NADU
9710071284
drkannancrf@gmail.com
Dr Pooja Khosla
Sir Ganga Ram Hospital
Sir Ganga Ram Hospital Marg, Old Rajinder Nagar, New Rajinder Nagar, New Delhi, Delhi 110060 Central DELHI
9818288194
drpoojakhosla@yahoo.com
Dr Sujith H
Subbaiah Institute of Medical Sciences
Ground Floor, Main OPD block,
Subbaiah Institute of Medical Sciences
NH-13, HH Road Purle Shivamogga Karnataka -577202
Shimoga KARNATAKA
ETHICS COMMITTEE GMC and GGH Guntur Medical College, Kannavari Thota Main Road Guntur Guntur Andhra Pradesh - 522004 India
Approved
Ethics Committee Subbaiah Institute of Medical Sciences NH-13, HH Road Purle Shivamogga (Shimoga) Karnataka -577222 India
Approved
IEC King George Hospital, Maharanipeta, Collector Office Junction, Visakhapatnam- 530002, Andhra Pradesh, India
Approved
IEC NIMS, NIMS Medicity, Aralumoodu P.O., Neyyattinkara, Thiruvananthapuram Kerala - 695123 India
Approved
IEC-Saveetha Medical College Hospital, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu - 602105 India
Approved
Institutional Ethics Committee Kakatiya Medical College SVP Road Rangampet Street Warangal Urban Telangana - 506007 India
Approved
Institutional Ethics Committee Jubilee Mission Medical College Research Institute JMMCRI Jubilee Mission P.O Thrissur, Thrissur, Kerala-680005, India
Approved
Institutional Ethics Committee Yashwantrao Chavan Memorial Hospital, Pimpri. Sant Tukaram Nagar, Near D.Y. Patil Medical College, Vallabhnagar, Near Fire Brigade Station, Pimpri, Pune Maharashtra - 411018, India.
Approved
Noble Hospital Institutional Ethics Committee, Noble Hospitals Pvt. Ltd. ,Room No 5, Clinical Research Department Noble Annex, 153 A, Magarpatta City Road, Hadapsar Hadapsar (India) - 411013 India
Approved
Sir Ganga Ram Hospital Ethics Committee Sir Ganga Ram Hospital Marg, Old Rajinder Nagar, New Rajinder Nagar, New Delhi, Delhi 110060
Approved
Vijaya Ethics Committee, Vijaya Super Specialty Hospital, 16 -II/41 A. Raghava Cine Complex Road, Pogathota, Nellore, Andhra Pradesh – 524001, 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,
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
65.00 Year(s)
Gender
Both
Details
1. Admitted to a hospital and has confirmed Covid-19 infection (Moderate to Severe
2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures, understand and agrees to comply with planned study procedures
3. Male and non-pregnant female subjects aged 18 years and above
4. 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
5. Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare Directorate General of Health Services) Clinical Management Protocol COVID 19(Dated 03 Jul 2020): Clinical severity of moderate to severe.
6. 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
7. 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 DESREMTM
8. Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment
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
Percentage of patients with at least two-point improvement from baseline in clinical status on the 8-point Ordinal scale
Mortality rate
Day 14
Day 28
Secondary Outcome
Outcome
TimePoints
Incidence of Treatment Emergent AEs
Day 1 to Day 28
Proportion of patients with viral clearance (SARS CoV-2 negativity)
Day 7, Day 14/ Time of Discharge
Time to Recovery
Day 14
Time to SpO2 94 % on room air
Day 14 & Day 28
Time to first fever normalization
Day 14 & Day 28
Mean Change from Baseline
Assessment day upto Day 28
Target Sample Size
Total Sample Size="130" Sample Size from India="130" 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 4
Date of First Enrollment (India)
02/03/2022
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="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nil
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 DESREMTM in Indian patients with moderate to
severe Covid-19 disease.
Primary objective:
To determine the efficacy of DESREMTM
in patients with moderate to severe Covid-19, assessed by two-point
improvement from baseline in clinical status on the 8-point ordinal scale at
Day 14.
To determine the mortality rate in patients
with moderate to severe Covid-19 at Day 28 treated with DESREMTM
Secondary
objective:
Key
secondary Objective: To assess the safety and tolerability of DESREMTM
in patients with moderate to severe Covid-19.
Other secondary objectives: To assess efficacy
of DESREMTM in patients with moderate to severe Covid-19, by viral
clearance, fever normalization and time to
SpO2 ≥ 94% on room air.