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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04890509
• Other study ID #: BGBC020
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: October 2021
• Source: BerGenBio ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Bemcentinib
Bemcentinib capsules will be administered orally.

Other:
• SoC
The SoC will be administered based on local guidelines.

Locations

Country	Name	City	State
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	Maulana Azad Medical College	New Delhi
India	Sahyadri Specialty Hospital	Pune	Maharastra
India	Krishna Institute of Medical Sciences (KIMS Hospitals)	Secunderabad	Telangana
India	Nirmal Hospital Private Limited	Surat	Gujarat
South Africa	Tiervlei Trial Centre	Bellville	Cape Town
South Africa	Into Research	Groenkloof	Pretoria
South Africa	Worthwhile Clinical Trials, Lakeview Hospital	Mowbray	Benoni
South Africa	Vergelegen Mediclinic	Somerset West	Cape Town
South Africa	Clinical Projects Research	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
BerGenBio ASA

Countries where clinical trial is conducted

India,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Sustained Clinical Improvement of at Least 2 Points (from randomization)	Sustained clinical improvement is defined as improvement without subsequent worsening. Time to sustained clinical improvement of at least 2 points (from randomization) on a 9-point category ordinal scale. Live discharge from the hospital, or considered fit for discharge whichever comes first, by Day 29 will be reported.	Up to Day 29
Secondary	Percentage of Participants not Deteriorating According to the Ordinal Scale by 1, 2, or 3 Points	Percentage of participants not deteriorating according to the 9-point category Ordinal Scale (0= uninfected and 8= Death), by 1, 2, or 3 Points will be reported.	At Days 2, 8, 15, and 29
Secondary	Duration of Oxygen Use	Duration of oxygen use in terms of days will be reported.	Up to Day 29
Secondary	Number of Oxygen-free Days	Number of oxygen-free days will be reported.	Up to Day 29
Secondary	Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	SARS-CoV-2 viral load will be determined by polymerase chain reaction (PCR) in oropharyngeal/nasal swab while hospitalized.	At Days 1, 3, 5, 8, 11, 15, and 29
Secondary	Duration of Ventilation	Duration of ventilation will be reported in terms of days.	Up to Day 29
Secondary	Number of Ventilation-free Days	Number of ventilation-free days will be reported.	Up to Day 29
Secondary	Number of Participants with Any Form of New Ventilation Use	Number of participants with any form of new ventilation use will be reported.	Up to Day 29
Secondary	Duration of New Ventilation Use	Duration of new ventilation use will be reported in terms of days.	Up to Day 29
Secondary	Duration of Organ Support	Duration of organ support (e.g., including respiratory, renal, and cardiac support) will be calculated in days.	Up to Day 29
Secondary	Number of Participants with Response	Response Rate will be assessed on a 9-point category ordinal scale. Number of participants with response (defined as sustained clinical improvement of at least 2 points (from randomization) 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) will be reported.	At Days 2, 8, 15, and 29
Secondary	Time to Live Discharge From the Hospital	Time to live discharge from the hospital will be reported.	Up to Day 29
Secondary	Time From Treatment Start Date to Death	Time from treatment start date to death will be reported.	Up to Day 60
Secondary	Overall Mortality	Number of deaths will be reported.	At Days 15, 29, and 60
Secondary	Change in the Ratio of Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2)	Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2) will be measured daily from randomization to Day 15, hospital discharge, or death.	From randomization to Day 15, hospital discharge, or death (Up to 90 days)
Secondary	Number of Participants with Physical Examination Abnormalities	Number of participants with physical examinations (including presenting signs, height, weight) abnormalities will be reported.	Day 1
Secondary	Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical laboratory (Haematology, chemistry, liver function tests, coagulation) abnormalities will be reported.	Up to Day 29
Secondary	Number of Participants with Vital Signs (blood pressure/heart rate/temperature/respiratory rate) Abnormalities	Number of participants with vital signs (blood pressure/heart rate/temperature/respiratory rate) abnormalities will be reported.	Up to Day 29
Secondary	Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	From Baseline to Day 90
Secondary	Duration of Intensive Care Unit (ICU) and Hospitalization	Duration of ICU and hospitalization will be evaluated.	Up to 90 days
Secondary	National Early Warning Score 2 (NEWS2)	The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst).	At Days 15 and 29
Secondary	Time to NEWS2 of <=2, Maintained for at Least 24 Hours	The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements. The score ranges from 0 (best) to 23 (worst).	At Days 15 and 29
Secondary	Ranked Trajectory	Ranked trajectory will be calculated over 29 days, with trajectory ranked of the ordinal scale.	29 days