Clinical trial NCT04890509: A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
Official title: A Multicentre, Phase 2, Randomised Study to Assess the Efficacy and Safety of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: BerGenBio ASA
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Time to Sustained Clinical Improvement of at Least 2 Points
timeFrame: From randomization up to Day 29
Secondary outcomes:
measure: Percentage of Participants Not Deteriorating According to the Ordinal Scale by 1, 2, or 3 Points
timeFrame: At Days 2, 8, 15, and 29
measure: Duration of Oxygen Use (in Percentage)
timeFrame: Up to Day 29
measure: Duration of Oxygen-free Days (in Percentage)
timeFrame: Up to Day 29
measure: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
timeFrame: Day 1 (Baseline), 3, 5, 8, 11, 15, and 29
measure: Duration of Ventilation Use (in Percentage) by Hospital Survival Status
timeFrame: Up to Day 29
measure: Duration of Ventilation-free Days (in Percentage)- by Hospital Survival Status
timeFrame: Up to Day 29
measure: Number of Participants With Any Form of New Ventilation Use
timeFrame: Up to Day 29
measure: Duration of New Ventilation Use (in Percentage) by Hospital Survival Status
timeFrame: Up to Day 29
measure: Duration of Organ Support (in Percentage)
timeFrame: Up to Day 29
measure: Number of Participants With Response
timeFrame: At Days 2, 8, 15, and 29
measure: Time to Live Discharge From the Hospital
timeFrame: Up to Day 29
measure: Time to Death
timeFrame: Up to Day 60
measure: Overall Mortality
timeFrame: At Days 15, 29, and 60
measure: Change From Baseline in the Ratio of Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2)
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 90
measure: Duration of Intensive Care Unit (ICU)- (in Percentage)
timeFrame: Up to 90 days
measure: Duration of Hospitalization
timeFrame: Up to 90 days
measure: National Early Warning Score 2 (NEWS2)
timeFrame: At Days 15 and 29
measure: Time to NEWS2 of <=2, Maintained for at Least 24 Hours
timeFrame: Up to Day 29
measure: Ranked Trajectory Over 29 Days
timeFrame: 29 days
Other outcomes:
Locations:
city: Surat
country: India
facility: Unity Trauma Center and ICU, Unity Hospital
state: Gujarat
city: Mangalore
country: India
facility: Kasturba Medical College
state: Karnataka
city: Mysuru
country: India
facility: JSS Hospital
state: Karnataka
city: Nashik
country: India
facility: Chopda Medicare & Research Centre Pvt. Ltd (CMARC) - Magnum Heart Institute
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Specialty Hospital
state: Maharastra
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences (KIMS Hospitals)
state: Telangana
city: New Delhi
country: India
facility: Maulana Azad Medical College
city: Mowbray
country: South Africa
facility: Lakeview Hospital
state: Benoni
city: Bellville
country: South Africa
facility: Tiervlei Trial Centre
state: Cape Town
city: Somerset West
country: South Africa
facility: Vergelegen Mediclinic
state: Cape Town
city: Groenkloof
country: South Africa
facility: Into Research
state: Pretoria
city: Worcester
country: South Africa
facility: Clinical Projects Research
Study officials:
affiliation: BerGenBio ASA
name: Hani Gabra
role: STUDY_CHAIR
References: