Phase II Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
- Conditions
- Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028602
- Lead Sponsor
- BerGenBio ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 Ã?â?? 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of bemcentinib as add-on therapy to standard of care (SoC) in patients hospitalised with coronavirus disease 2019 (COVID-19)Timepoint: 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 ââ?¬Å?responderââ?¬? for the response rate analyses).
- Secondary Outcome Measures
Name Time Method -To evaluate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral loadTimepoint: 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 pointsTimepoint: 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 daysTimepoint: Duration (days) of oxygen use and oxygen-free days