Phase 2
Completed N=115
A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
Source: ClinicalTrials.gov NCT04890509 ↗Enrolled (actual)
115
Serious AEs
8.7%
Results posted
Oct 2024
Primary outcomePrimary: Time to Sustained Clinical Improvement of at Least 2 Points — 7.0; 7.0 days
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sustained Clinical Improvement of at Least 2 Points |
7.0; 7.0 | — |
| SECONDARY Percentage of Participants Not Deteriorating According to the Ordinal Scale by 1, 2, or 3 Points |
95.7; 86.0; 96.6; 87.7; 96.6; 91.2 | — |
| SECONDARY Duration of Oxygen Use (in Percentage) |
53.33; 56.38 | — |
| SECONDARY Duration of Oxygen-free Days (in Percentage) |
46.67; 43.62 | — |
| SECONDARY Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load |
18739475; 882663; 2293266; 5081599; 140383; 742869 | — |
| SECONDARY Duration of Ventilation Use (in Percentage) by Hospital Survival Status |
1.68; 6.20; 31.36; 73.99 | — |
| SECONDARY Duration of Ventilation-free Days (in Percentage)- by Hospital Survival Status |
98.32; 93.80; 68.64; 26.01 | — |
| SECONDARY Number of Participants With Any Form of New Ventilation Use |
1; 6 | — |
| SECONDARY Duration of New Ventilation Use (in Percentage) by Hospital Survival Status |
0.00; 3.26; 31.36; 46.96 | — |
| SECONDARY Duration of Organ Support (in Percentage) |
1.0; 1.0 | — |
| SECONDARY Number of Participants With Response |
1; 4; 37; 32; 54; 50 | — |
| SECONDARY Time to Live Discharge From the Hospital |
7.0; 7.0 | — |
| SECONDARY Time to Death |
NA; NA | — |
| SECONDARY Overall Mortality |
1; 3; 2; 3; 4; 4 | — |
| SECONDARY Change From Baseline in the Ratio of Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) |
1.65; -6.21; 2.31; -2.57; 2.82; -23.03 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
18; 22 | — |
| SECONDARY Duration of Intensive Care Unit (ICU)- (in Percentage) |
32.03; 40.89 | — |
| SECONDARY Duration of Hospitalization |
9.8; 10.5 | — |
| SECONDARY National Early Warning Score 2 (NEWS2) |
1.8; 2.2; 0.8; 0.7 | — |
| SECONDARY Time to NEWS2 of <=2, Maintained for at Least 24 Hours |
4.0; 4.0 | — |
| SECONDARY Ranked Trajectory Over 29 Days |
58.2; 57.8 | — |
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:
- 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.
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:
- Myocardial infarction within 3 months prior to the first dose
- Unstable angina
- History of clinically significant dysrhythmias (long QT features on electrocardiogram [ECG], sustained bradycardia [less than or equal to { ) 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.
Data sourced from ClinicalTrials.gov (NCT04890509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.