Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 (AXL-SolidAct)

Phase 1

• Conditions: SARS CoV-2 (COVID-19); MedDRA version: 21.1Level: LLTClassification code: 10037373Term: Pulmonary disorder Class: 10038738; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2022-500363-12-00
• Lead Sponsor: Oslo University Hospital Hf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-19
• Study Completion: 2023-12-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

GI1. Over 18 years of age, GI2. Documented laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR or antigen test in any specimen not more than 10 days old., GI3. Admitted to hospital., GI4. Informed consent by the participant., GI5. Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed., SI-01. Moderate pulmonary COVID19 disease defined as mainly lower respiratory symptoms and either: i) need of oxygen by mask or nasal prongs, or ii) current radiologic evidence of new pulmonary infiltrates consistent with COVID pneumonitis.

Exclusion Criteria

GE1. Anticipated transfer to another non-trial hospital within 72 hours., SE-01. Unable to swallow capsules., SE-02 Hospitalised for reasons other than pulmonary COVID19 disease, unless developing nosocomial pulmonary COVID-19 during hospitalisation, SE-03. History any 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 ECG, sustained bradycardia [=55 bpm]), left bundle branch block, or ventricular arrhythmia) or history of familial long QT. Note: Patients with an implantable cardioverter defibrillator device in place, will be allowed to enrol. Atrial fibrillation will not be a reason for exclusion., SE-04. Screening 12-lead ECG with a measurable QT interval according to Fridericia correction (QTcF) >470 msec (triplicate at baseline)., SE-05. Treatment with a concomitant medication with increased risk of Torsade-de-Pointes arrhythmia or significant electrocardiographic QT prolonging effect that cannot be safely discontinued. Note: The list includes but is not limited to (in alphabetical order) Amiodarone, Astemizole, Azithromycin, Chloroquine, Citalopram, Clarithromycin, Cocaine, Disopyramide, Droperidol, Erythromycin, Escitalopram, Fluconazole, Haloperidol, Ketoconazole, Methadone, Moxifloxacin, Ondansetron, Petamidine, Pimozide, Procainamide, Quinidine, Sotalol, Terfenadine, Thioridazine, Voriconazole. Concomitant treatment with CYP 3A4 substrates that have a narrow therapeutic window should also be discontinued (with the exception of fluticasone detailed below). The following should be discontinued (in alphabetical order) Alfentanyl, Cisapride, Cyclosporine, Ergotamine/ Dihydroergotamine, Fentanyl , Sirolimus, Tacrolimus. Fluticasone may continue without interruption when administered either nasally or inhaled. Note: If a medication can be safely discontinued, the 2-day bemcentinib loading regime may be started as long as the QTcF on prior therapy is not prolonged above that required for eligibility (470 ms)., SE-06. Therapeutic anticoagulation with vitamin K antagonists., SE-07. Previous bowel resection/ bowel dysfunction that would interfere with drug absorption., SE-08. Alanine aminotransferase/aspartate aminotransferase = 5 × the upper limit of normal., SE-17. Experimental off-label usage of medicinal products as treatments for COVID-19 at the time of enrolment unless these are defined as SOC., SE-18. Neutrophil count <500 cells/uL, SE-09. Severe chronic kidney disease. Subjects with estimated glomerular filtration rate (eGFR) <30 millilitre/minute/1.73 meters squared are excluded., SE-19. Known uncontrolled chronic viral infection (including HIV, HBV, HCV). Note: Screening for viral infections is not mandatory., SE-10. Individuals with clinically significant hypokalaemia (<3.0 mmol/l) are excluded. Note: Individuals who do not meet this criterion may be rescreened once, after correction of electrolyte abnormality., SE-11: Patients on current or planned pharmaceutical treatment for tuberculosis., SE-12. Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study. Note: Women of childbearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements for women and men., SE-13. Participation in other therapeutic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified