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

NCT04890509 | Completed Phase 2 Results DMC

• 1 other identifier: BGBC020
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• Time to Sustained Clinical Improvement of at Least 2 Points

  Sustained clinical improvement is defined as improvement without subsequent worsening. Time to sustained clinical improvement (in days) from randomization is defined as the number of days to a sustained improvement of at least 2 points on a 9-point category ordinal scale, or live discharge from the hospital, or fit for discharge, whichever occurs first by Day 29. 9-point category ordinal scale: 0-Uninfected, no clinical or virological evidence of infection; 1-Ambulatory, no limitation of activities; 2-Ambulatory, limitation of activities; 3-Hospitalised - mild disease, no oxygen therapy; 4-Hospitalized - mild disease, oxygen by mask or nasal prongs; 5-Hospitalized - severe disease, non-invasive ventilation or high-flow oxygen; 6-Hospitalized - severe disease, intubation and mechanical ventilation; 7-Hospitalized - severe disease, ventilation and additional organ support - vasopressors, renal replacement therapy, extracorporeal membrane oxygenation; 8-Death.

  From randomization up to Day 29

Secondary Outcomes (20)

• Percentage of Participants Not Deteriorating According to the Ordinal Scale by 1, 2, or 3 Points

  At Days 2, 8, 15, and 29

• Duration of Oxygen Use (in Percentage)

  Up to Day 29

• Duration of Oxygen-free Days (in Percentage)

  Up to Day 29

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load

  Day 1 (Baseline), 3, 5, 8, 11, 15, and 29

• Duration of Ventilation Use (in Percentage) by Hospital Survival Status

  Up to Day 29

Study Arms (2)

Standard of Care + Bemcentinib

EXPERIMENTAL

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.

Drug: Bemcentinib; Other: SoC

Standard of Care

ACTIVE COMPARATOR

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

Other: SoC

Interventions

Bemcentinib DRUG

Bemcentinib capsules will be administered orally.

Standard of Care + Bemcentinib

SoC OTHER

The SoC will be administered based on local guidelines.

Standard of Care; Standard of Care + Bemcentinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Not a woman of childbearing potential. OR
• 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.

You may not qualify if:

• 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:
• Myocardial infarction within 3 months prior to the first dose
• Unstable angina
• 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.

Sponsors & Collaborators

• BerGenBio ASA: lead

Study Sites (12)

Unity Trauma Center and ICU, Unity Hospital

Surat, Gujarat, 395002, India

Location

Kasturba Medical College

Mangalore, Karnataka, 575001, India

Location

JSS Hospital

Mysuru, Karnataka, 570 004, India

Location

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

Nashik, Maharashtra, 422005, India

Location

Sahyadri Specialty Hospital

Pune, Maharashtra, 411004, India

Location

Krishna Institute of Medical Sciences (KIMS Hospitals)

Secunderabad, Telangana, 500003, India

Location

Maulana Azad Medical College

New Delhi, 110002, India

Location

Lakeview Hospital

Mowbray, Benoni, South Africa

Location

Tiervlei Trial Centre

Bellville, Cape Town, South Africa

Location

Vergelegen Mediclinic

Somerset West, Cape Town, South Africa

Location

Into Research

Groenkloof, Pretoria, South Africa

Location

Clinical Projects Research

Worcester, South Africa

Location

MeSH Terms

Conditions

COVID-19

Interventions

bemcentinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: BerGenBio Clinical Team
• Organization: BerGenBio ASA

cmo@bergenbio.com

+ 47 559 61 159

Study Officials

• Hani Gabra

  BerGenBio ASA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: October 20, 2020
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Proposal should be directed to HYPERLINK "mailto:clinical@bergenbio.com" clinical@bergenbio.com. To gain access, data requestors will need to sign a data access agreement.

Locations

IN (7); ZA (5)