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
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
Approved
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
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.
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).
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"
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.
