A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients

NCT ID: NCT04890509

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2021-05-25

Brief Summary

The primary objective of the study is to evaluate the efficacy of bemcentinib as an add-on therapies to standard of care (SoC) in participants hospitalized with coronavirus disease 2019 (COVID-19).

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care + Bemcentinib

Bemcentinib will be administered for up to 15 days, or until discharge from hospital, whichever comes sooner. SoC will be administered based on local guidelines.

Group Type: EXPERIMENTAL

Bemcentinib

Intervention Type: DRUG

Bemcentinib capsules will be administered orally.

SoC

Intervention Type: OTHER

The SoC will be administered based on local guidelines.

Standard of Care

The SoC will be administered based on local guidelines in place at the time of treatment during the study.

Group Type: ACTIVE_COMPARATOR

SoC

Intervention Type: OTHER

The SoC will be administered based on local guidelines.

Interventions

Bemcentinib

Bemcentinib capsules will be administered orally.

Intervention Type: DRUG

SoC

The SoC will be administered based on local guidelines.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (greater than or equal to [>=] 18 years) with SARS-CoV-2 infection.
• Participants with symptoms and/or signs consistent with COVID-19, requiring treatment.
• A score of Grade 3 to 5 on the 9-point ordinal scale. In India; only Participants with a score of Grade 4 or 5 will be enrolled.
• a) Male Participants:
• A male Participant must agree to use contraception 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 Participants:

• A female Participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

1. Not a woman of childbearing potential. OR

2. A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

• 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).
• Ability to provide informed consent signed by the study Participant or legally authorized representative.

Exclusion Criteria

• Participants who have previously had a score of 6 or 7 on the 9-point ordinal scale.
• Inability to swallow capsules (administration via nasogastric tube is permitted in Participants who become unable to swallow after starting the study drug).
• History of the following cardiac conditions:

1. Myocardial infarction within 3 months prior to the first dose

2. Unstable angina

3. History of clinically significant dysrhythmias (long QT features on electrocardiogram [ECG], sustained bradycardia [less than or equal to {<=} 55 beats per minute {bpm}]), left bundle branch block, or ventricular arrhythmia) or history of familial long QT. Participants with an implantable cardioverter defibrillator device in place, will be allowed to enroll. Atrial fibrillation will not be a reason for exclusion.

• Screening 12-lead ECG with a measurable QT interval according to Fridericia correction (QTcF) greater than (>) 470 msec.
• Clinically significant hypokalaemia.
• Therapeutic anticoagulation with vitamin K antagonists.
• Previous bowel resection that would interfere with drug absorption.
• Any participant whose interests are not best served by study participation, as determined by a senior attending clinician.
• Alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal.
• Current treatment for human immunodeficiency virus (HIV) or tuberculosis (TB).
• 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.
• Stage 4 severe chronic kidney disease.
• Anticipated transfer to another hospital that is not a study center within 72 hours.
• Allergy to any study treatment.
• Experimental off-label usage of medicinal products as treatments for COVID-19 at the time of enrolment.
• Participants participating in another clinical study of an investigational medicinal product.
• Current or planned treatment for TB.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BerGenBio ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hani Gabra

Role: STUDY_CHAIR

BerGenBio ASA

Locations

Unity Trauma Center and ICU, Unity Hospital

Surat, Gujarat, India

Kasturba Medical College

Mangalore, Karnataka, India

JSS Hospital

Mysuru, Karnataka, India

Chopda Medicare & Research Centre Pvt. Ltd (CMARC) - Magnum Heart Institute

Nashik, Maharashtra, India

Sahyadri Specialty Hospital

Pune, Maharashtra, India

Krishna Institute of Medical Sciences (KIMS Hospitals)

Secunderabad, Telangana, India

Maulana Azad Medical College

New Delhi, , India

Lakeview Hospital

Mowbray, Benoni, South Africa

Tiervlei Trial Centre

Bellville, Cape Town, South Africa

Vergelegen Mediclinic

Somerset West, Cape Town, South Africa

Into Research

Groenkloof, Pretoria, South Africa

Clinical Projects Research

Worcester, , South Africa

Countries

India; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BGBC020

Identifier Type: -

Identifier Source: org_study_id