A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Bemcentinib
Bemcentinib capsules will be administered orally.
Other: SoC
The SoC will be administered based on local guidelines.
|
| Active Comparator: Standard of Care The SoC will be administered based on local guidelines in place at the time of treatment during the study. |
Other: SoC
The SoC will be administered based on local guidelines.
|
Outcome Measures
Primary Outcome Measures
- Time to Sustained Clinical Improvement of at Least 2 Points (from randomization) [Up to Day 29]
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.
Secondary Outcome Measures
- Percentage of Participants not Deteriorating According to the Ordinal Scale by 1, 2, or 3 Points [At Days 2, 8, 15, and 29]
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.
- Duration of Oxygen Use [Up to Day 29]
Duration of oxygen use in terms of days will be reported.
- Number of Oxygen-free Days [Up to Day 29]
Number of oxygen-free days will be reported.
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [At Days 1, 3, 5, 8, 11, 15, and 29]
SARS-CoV-2 viral load will be determined by polymerase chain reaction (PCR) in oropharyngeal/nasal swab while hospitalized.
- Duration of Ventilation [Up to Day 29]
Duration of ventilation will be reported in terms of days.
- Number of Ventilation-free Days [Up to Day 29]
Number of ventilation-free days will be reported.
- Number of Participants with Any Form of New Ventilation Use [Up to Day 29]
Number of participants with any form of new ventilation use will be reported.
- Duration of New Ventilation Use [Up to Day 29]
Duration of new ventilation use will be reported in terms of days.
- Duration of Organ Support [Up to Day 29]
Duration of organ support (e.g., including respiratory, renal, and cardiac support) will be calculated in days.
- Number of Participants with Response [At Days 2, 8, 15, and 29]
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.
- Time to Live Discharge From the Hospital [Up to Day 29]
Time to live discharge from the hospital will be reported.
- Time From Treatment Start Date to Death [Up to Day 60]
Time from treatment start date to death will be reported.
- Overall Mortality [At Days 15, 29, and 60]
Number of deaths will be reported.
- Change in the Ratio of Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) [From randomization to Day 15, hospital discharge, or death (Up to 90 days)]
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.
- Number of Participants with Physical Examination Abnormalities [Day 1]
Number of participants with physical examinations (including presenting signs, height, weight) abnormalities will be reported.
- Number of Participants with Clinical Laboratory Abnormalities [Up to Day 29]
Number of participants with clinical laboratory (Haematology, chemistry, liver function tests, coagulation) abnormalities will be reported.
- Number of Participants with Vital Signs (blood pressure/heart rate/temperature/respiratory rate) Abnormalities [Up to Day 29]
Number of participants with vital signs (blood pressure/heart rate/temperature/respiratory rate) abnormalities will be reported.
- Number of Participants with Adverse Events (AEs) [From Baseline to Day 90]
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.
- Duration of Intensive Care Unit (ICU) and Hospitalization [Up to 90 days]
Duration of ICU and hospitalization will be evaluated.
- National Early Warning Score 2 (NEWS2) [At Days 15 and 29]
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).
- Time to NEWS2 of <=2, Maintained for at Least 24 Hours [At Days 15 and 29]
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).
- Ranked Trajectory [29 days]
Ranked trajectory will be calculated over 29 days, with trajectory ranked of the ordinal scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults (greater than or equal to [>=] 18 years) with SARS-CoV-2 infection.
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Participants with symptoms and/or signs consistent with COVID-19, requiring treatment.
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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.
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- Male Participants:
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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.
- 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:
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Not a woman of childbearing potential. OR
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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.
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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).
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Ability to provide informed consent signed by the study Participant or legally authorized representative.
Exclusion Criteria:
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Participants who have previously had a score of 6 or 7 on the 9-point ordinal scale.
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Inability to swallow capsules (administration via nasogastric tube is permitted in Participants who become unable to swallow after starting the study drug).
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History of the following cardiac conditions:
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Myocardial infarction within 3 months prior to the first dose
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Unstable angina
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History of clinically significant dysrhythmias (long QT features on electrocardiogram [ECG], sustained bradycardia [less than or equal to {<=} 55 beats per minute ]), 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.
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Screening 12-lead ECG with a measurable QT interval according to Fridericia correction (QTcF) greater than (>) 470 msec.
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Clinically significant hypokalaemia.
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Therapeutic anticoagulation with vitamin K antagonists.
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Previous bowel resection that would interfere with drug absorption.
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Any participant whose interests are not best served by study participation, as determined by a senior attending clinician.
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Alanine aminotransferase/aspartate aminotransferase >5 × the upper limit of normal.
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Current treatment for human immunodeficiency virus (HIV) or tuberculosis (TB).
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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.
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Stage 4 severe chronic kidney disease.
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Anticipated transfer to another hospital that is not a study center within 72 hours.
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Allergy to any study treatment.
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Experimental off-label usage of medicinal products as treatments for COVID-19 at the time of enrolment.
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Participants participating in another clinical study of an investigational medicinal product.
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Current or planned treatment for TB.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nirmal Hospital Private Limited | Surat | Gujarat | India | 395002 |
| 2 | Kasturba Medical College | Mangalore | Karnataka | India | 575001 |
| 3 | JSS Hospital | Mysuru | Karnataka | India | 570 004 |
| 4 | Chopda Medicare & Research Centre Pvt. Ltd (CMARC) - Magnum Heart Institute | Nashik | Maharashtra | India | 422005 |
| 5 | Sahyadri Specialty Hospital | Pune | Maharastra | India | 411004 |
| 6 | Krishna Institute of Medical Sciences (KIMS Hospitals) | Secunderabad | Telangana | India | 500003 |
| 7 | Maulana Azad Medical College | New Delhi | India | 110002 | |
| 8 | Worthwhile Clinical Trials, Lakeview Hospital | Mowbray | Benoni | South Africa | |
| 9 | Tiervlei Trial Centre | Bellville | Cape Town | South Africa | |
| 10 | Vergelegen Mediclinic | Somerset West | Cape Town | South Africa | |
| 11 | Into Research | Groenkloof | Pretoria | South Africa | |
| 12 | Clinical Projects Research | Worcester | South Africa |
Sponsors and Collaborators
- BerGenBio ASA
Investigators
- Study Chair: Hani Gabra, BerGenBio ASA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGBC020