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CTRI Number  CTRI/2020/10/028602 [Registered on: 23/10/2020] Trial Registered Prospectively
Last Modified On: 19/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Phase II Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients 
Scientific Title of Study   A Multicentre, Phase 2, Randomised Study to Assess the Efficacy and Safety of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients 
Secondary IDs if Any  
Secondary ID  Registry 
BGBC020 dated 08-Oct-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Scientific Query
 
Name  Suneela Thatte  
Address  IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station Andheri East Mumbai 400 069 Mumbai Mumbai MAHARASHTRA 400 069 India

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242   
Fax    
Email  suneela.thatte@iqvia.com  
 
Details Contact Person
Public Query
 
Name  Suneela Thatte  
Address  IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station Andheri East Mumbai 400 069 Mumbai Mumbai MAHARASHTRA 400 069 India


MAHARASHTRA
400069
India 
Phone  912266774242   
Fax    
Email  suneela.thatte@iqvia.com  
 
Source of Monetary or Material Support  
BerGenBio ASA Jonas Lies vei 91 5009 Bergen NORWAY  
 
Primary Sponsor  
Name  BerGenBio ASA 
Address  Jonas Lies vei 91 5009 Bergen NORWAY  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDSIndia Pvt Ltd  2nd Floor, Etamin Block, Prestige Technology Park II Sarjapur-Marathahalli Outer Ring Road, Bangalore-560103 Karnataka  
 
Countries of Recruitment     India
South Africa  
Sites of Study  
No of Sites = 7  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Manojkumar Chopada  Chopda Medicare & Research Centre Pvt Ltd  Dept of Cardiology, Ground Floor,NA – OPD ,Magnum Heart Institute, 3/5, Patil Lane No, Laxmi Nagar, Near K.B.H Vidyalaya, Canada Corner, Nashik – 422005, Maharashtra
Nashik
 
9823021613
02532313613
drchopdamanoj@gmail.com 
Dr Prathibha Pereira  JSS Hospital  Dept of Geriatric , 1st Floor, 1002, MG Road, Mysuru – 570004, Karnataka
Mysore
 
9448282506
0821-2335556
ppatta08@gmail.com 
Dr John Ramapuram  Kasturba Medical College Hospital (a constituent institution of MAHE, Manipal)  Dept of Medicine,1st Floor,14,Attavar, Mangaluru-575001, Karnataka
Udupi
 
9880735516
08242428379
john@ramapuram.net 
Dr Sambit Sahu  Krishna Institute of Medical Sciences Limited  Dept of Medicine,Block 3, 5th floor,MICU 3 ,1-8-31/1, Minister Road, Secunderabad -500003, Telangana
Hyderabad
 
9989005763
04027840980
Sambit2k@yahoo.com 
Dr Naresh Kumar  Maulana Azad Medical College  Dept of Medicine,1st Floor,125, B L Taneja Block, Maulana Azad Medical College, New Delhi- 110002, Delhi
New Delhi
 
9953946064

drnareshmamc@gmail.com 
Dr Atul Arvind Joshi  Sahyadri Super Specialty Hospital  Dept of General Medicine and Critical Care ,1st floor , NA – OPD, 30 C, Erandwane, Karve Road, Pune – 411004, Maharashtra
Pune
 
9822430776
09102025449117
aj@sahyadrihospitals.com 
Dr Maheshkumar Sutariya  Unity Hospital  Intensive Care Unit ,3rd Floor, Nr. D.R. World, Opp Raghuvir Business Empire, Aai Mata Rd, Parvat Patiya, Surat- 395010, Gujarat
Surat
 
9978803833

sutariyadrmahesh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
3rd floor, Intensive Care Unit, Unity Hospital Ethics Committee, Unity Trauma Center And ICU, N-4 Janki Park Society,Aai Mata Road, Paravat Patiya Surat– 395010  Approved 
OPD, 1st floor , Dept of General Medicine and Critical Care, Sahyadri Hospital Ltd Ethics Committee, Sahyadri Clinical Research and Development Center, 33/34B Makaranda, Bhave Path, Karve Road, Pune – 411038  Approved 
OPD, Ground Floor, Dept of Cardiology, Magna-care Ethics Committee Chopda Medicare and Research Centre Pvt. Ltd, Magnum Heart Institute Canada Corner Nashik- 422005  Approved 
Room No: 1002, 1st floor, Dept of Geriatric, Institutional Ethics Committee JSS Medical College, JSS Medical College and Hospital, Sri Shivarathreeshwara Nagar, Mysuru-570015  Approved 
Room No: 125, 1st floor, Dept of Medicine, Lok Nayak Hospital 1st floor 24 emergency gate no 4, New Delhi – 110002  Submittted/Under Review 
Room No: 14, Dept of Medicine, 1st Floor, MAHE Ethics Committee Manipal Academy of Higher Education, manipal.edu bldg Madhav Nagar, Manipal Udupi– 576104  Approved 
Room No: MICU 3, Block 3, 5th floor, Dept of Medicine, KIMS Ethics Committee, 1-8-31/1, Krishna Institute of Medical Sciences Limited, Minister Road, Secunderabad – 500003  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients   
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Bemcentinib (BGB324) 100mg Oral   1)400mg of will be given on Day 1 through Day 3 2)200mg of will be given on Day 4 through Day 15  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of theInvestigator, it is relevant to ongoing COVID 19).
2.Patients with symptoms and/or signs consistent with COVID-19, requiring treatment.
3.A score of Grade 3 to 5 on the 9-point ordinal scale.In India; only patients with a score of Grade 4 or 5 will be enrolled.
4. a) Male patients:
•A male patient must agree to use contraception as detailed in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
b) Female patients:
•A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
i Not a woman of childbearing potential
OR
iiA woman of childbearing potential who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment.
5.Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded).
6.Ability to provide informed consent signed by the study patient or legally authorised representative.

 
 
ExclusionCriteria 
Details  1.Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale.
2.Inability to swallow capsules (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug)
3.History of the following cardiac conditions:
a)Myocardial infarction within 3 months prior to the first dose
b)Unstable angina
c)History of clinically significant dysrhythmias (long QT features on ECG, sustained bradycardia [≤55 bpm]), left bundle branch block, or ventricular arrhythmia) or history of familial long QT.Patients with an implantable cardioverter defibrillator device in place, will be allowed to enrol. Atrial fibrillation will not be a reason for exclusion.
4.Screening 12-lead ECG with a measurable QT interval according to Fridericia correction (QTcF) >470 msec. In the presence of a cardiac pacemaker, QTcF will need to be calculated from an ECG which has been recorded during a period where ventricular (QRS) complexes without pacing are present. If no unpaced ventricular complexes are present to allow calculation of QTcF, the patient should not be enrolled in this protocol
5.Clinically significant hypokalaemia: Individuals who do not meet this criterion may be rescreened once, after correction of 6.Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included.
7.Previous bowel resection that would interfere with drug absorption.
8.Any patient whose interests are not best served by study participation, as determined by a senior attending clinician.
9.Alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal electrolyte abnormality.
10.Current treatment (or planned initiation of treatment during the first 15 days of the study) for human immunodeficiency virus (HIV) or tuberculosis (TB).
11.Positive serologic assay at screening for hepatitis B virus (Hep B surface antigen) or hepatitis C virus (hepatitis C PCR or hepatitis C core antigen) at local laboratory.
12.Stage 4 severe chronic kidney disease.
13.Anticipated transfer to another hospital that is not a study centre within 72 hours.
14.Allergy to any study treatment.
15.Experimental off-label usage of medicinal products as treatments for COVID-19 (except where the product has either been given a positive opinion under the Early Access to Medicines Scheme [EAMS] or is a SARS-CoV-2 vaccine) at the time of enrolment.
16.Patients participating in another clinical study of an investigational medicinal product.
17.Current or planned treatment for tuberculosis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the efficacy of bemcentinib as add-on therapy to standard of care (SoC) in patients hospitalised with coronavirus disease 2019 (COVID-19)  Time to sustained clinical improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the “responder” for the response rate analyses). 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
-To evaluate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load  Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and 29 
-To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points  The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, and 29  
-To evaluate the number of oxygen-free days  Duration (days) of oxygen use and oxygen-free days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/11/2020 
Date of First Enrollment (Global)  20/10/2020 
Estimated Duration of Trial   Years="0"
Months="3"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
NIL 
Brief Summary  

BGBC020 is a study designed to rapidly seek and determine the nature of signals of efficacy and safety of bemcentinib in the treatment of hospitalised patients with SARS-CoV2. The study design is analogous to the first stage of the ACCORD-2 platform protocol, a multicentre national UK government sponsored protocol in the United Kingdom in which bemcentinib is being evaluated.

 BGBC020 will include hospitalised adult patients (≥18 years) who have infection with SARS-CoV-2, the virus that causes COVID-19, as confirmed by laboratory tests and/or validated point of care tests. For inclusion, patients will need to have clinical status of Grade 3 (hospitalised - mild disease, no oxygen therapy) to Grade 5 (hospitalised – severe disease, non-invasive ventilation or high-flow oxygen), as defined by a 9-point ordinal scale. In India, only patients with Grade 4 or 5 will be enrolled as patients not requiring oxygen (Grade 3) are not admitted to hospital in accordance with national therapeutic guidelines.

 Patients will be randomised (1:1) to treatment arm to receive bemcentinib (as an add-on to standard of care [SoC]) or to control arm where only SoC will be administered.

 

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