| CTRI Number |
CTRI/2021/12/039011 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Assess the Safety and Efficacy of Remdesivir in COVID-19 infected Indian patients |
|
Scientific Title of Study
|
A Multi-Center, Open label, Post approval for restricted use under emergency situation study to assess the Safety and Efficacy of Remdesivir in moderate to severe SARS CoV2 infection (COVID 19) in Indian patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JUB-REM-001 version 3.0 dated 24 Aug 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devanshu Garg |
| Designation |
Director -Pharmacovigilance |
| Affiliation |
Jubilant Generics Limited |
| Address |
C-46, Sector 62
Noida, UP, India Pin – 201307
Gautam Buddha Nagar
UTTAR PRADESH
201307
India |
| Phone |
91-120-4364000 |
| Fax |
|
| Email |
devanshu.garg@jubl.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 Delhi Mathura Road, Near Saraj Khwaja Metro Station Faridabad
Haryana- 121003 India
Faridabad
HARYANA
121003
India |
| Phone |
918800799887 |
| Fax |
|
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Head- 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
Delhi Mathura Road, Near Saraj Khwaja Metro Station Faridabad
Haryana 121003 India
Faridabad
HARYANA
121003
India |
| Phone |
9771407484 |
| Fax |
|
| Email |
jayashri.krishnan@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Jubilant Generics Limited
C-46, Sector 62
Noida, UP, India Pin – 201307
|
|
|
Primary Sponsor
|
| Name |
Jubilant Generics Limited |
| Address |
C-46, Sector 62 Noida, UP, India Pin – 201307 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jabir M P |
Aster MIMS hospital |
Department of General Medicine,
Room No.127B, First floor,
Aster MIMS Calicut,
Govindapuram
P.O Calicut 673016.
Ernakulam
KERALA |
91-6235707744
jabir.zubair@gmail.com |
| DrAmbanna Gowda |
Citizen hospital |
Department of General Medicine,
Consultation room,
Ground floor,
No-14, 2nd, Main Road,
Dispensary Road,
Kalasipalyam,
Bangalore 560002, India.
Bangalore
KARNATAKA |
9845270377
dr.ambanagowda@gmail.com |
| Dr Virendra CPatil |
Krishna Institute of Medical Sciences Deemed to be University |
Clinical Trial unit,
Second floor of medical college,
Krishna Institute of Medical Sciences Deemed to be University
Pune- Bangalore Highway-4,
Malkapur road
Karad,
District-Satara,
Maharashtra-415539
Satara
MAHARASHTRA |
8806111140
virendracpkimsu@rediffmail.com |
| Dr Badal Kumar Sahu |
Nil Ratan Sircar Medical college and hospital |
Department of General Medicine,
5th floor,
No138, Acharya
Jadadish Chandra Bose Road,
Sealdah,
Kolkata-700014, West Bengal.
Kolkata
WEST BENGAL |
8240184543
drbadal08@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee C/3 Shree Complex, Opposite Mahavir Nagar, Manapada Road, Dombivali (E), Maharashtra-421201, India |
Approved |
| Citizen Hospital Institutional Ethics Committee, Citizen Wellness LLP, new 14, 2nd Main Road, Kalasipalya Extn. Bangalore Urban – 560002 |
Approved |
| Ethics Committee, N.R.S Medical college, EC address: NRS Medical college and hospital NRS Medical College 138 A.J.C Bose Road, Kolkata, West Bengal- 700014, India. |
Approved |
| IEC of Krishna Institute of Medical Sciences Krishna Institute of Medical Sciences Deemed to be University Karad Pune- Bangalore Highway-4, Malkapur Karad, District-Satara, Maharashtra-415539 |
Approved |
| Institutional Ethics Committee Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad-500082, Telangana, India |
Approved |
| Institutional Ethics Committee for ESIC Faridabad, ESIC Medical College And Hospital, NH-3, NIT, Behind BK Hospital, Faridabad, Haryana, India – 121001 |
Approved |
| MIMS IEC Malabar Institute of Medical Sciences Mini Bypass Road P.O.Govindapuram Kozhikode Kerala – 673016,lndia |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Remdesivir for Injection 100mg Lyophilized Powder |
a single loading dose of 200 mg infused intravenously over 30 to 120 minutes on Day 1 followed by once-daily maintenance doses of 100 mg infused intravenously over 30 to 120 minutes for 4 days (day 2 through day 5).
Dose, Frequency Route of Administration & duration of therapy:
The recommended dosage in adults -
The dosage of remdesivir is a single loading dose of 200 mg infused intravenously over 30 to 120 minutes on Day 1 followed by once-daily maintenance doses of 100 mg infused intravenously over 30 to 120 minutes for 4 days (day 2 through day 5).
Treatment period
It will be of 5-day duration.
Same has been updated in the respective section on the portal for your kind consideration and acceptance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age -18 years and above (no upper age limit)
2. Patients admitted in hospital with a proven diagnosis of moderate to severe COVID 19 infection.
3. Patients with moderate disease defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
4. Patients with severe disease defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
2. Inability of subject or legally authorized representative to provide written informed consent.
3. Patients with <40 kg body weight
4. eGFR less than 30 mL per minute
5. Pregnant or nursing women
6. Patients with ALT/AST ≥ 5 times the upper limit of normal at baseline
7. Evidence of multiorgan failure
8. Mechanically ventilated (including Veno-Venous ECMO) ≥ 5 days, or any duration of Veno-Arterial ECMO
9. Exposed to other investigational drugs within 30 day of first administration of Remdesivir.
10. Unsuitable for the study in the opinion of the Investigator. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time to recovery [ Time Frame: Day 1 through Day 28]
2.Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
3.Percentage of subjects with improvement of at least 2 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28]
4.Mortality rate at Day 28 |
28 days of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of subjects with improvement of at least 1 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28]
2. Proportion of subjects with viral clearance (SARS CoV-2 negativity) at Day 7 and Day 14 or at hospital discharge (whichever is earlier)
3. Incidence of laboratory adverse events
4. Incidence of clinical adverse events
5. Incidence of serious adverse events (SAEs) |
28 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2022 |
| 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
|
COVID-19 is a respiratory illness that has led to a pandemic affecting more than 200 countries in the world. It is caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has a significant genomic homology to SARS and MERS viruses. It is caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has a significant genomic homology to SARS and MERS viruses. Remdesivir is authorized for use for treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and moderate to severe disease Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate. As per the definition of MoHFW guidelines: Moderate disease is defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute. Severe disease is defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air. |