A platform to investigate the safety and effectiveness of several new medicines for the treatment of COVID-19 in hospitalised patients

Phase 2

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN57085639
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32736596/ (added 13/08/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37868151/ (added 06/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-24
• Study Completion: 2021-09-04
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Adults (=18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests
2. A score of Grade 3 to 5 on the 9-point ordinal scale.
3. Is a woman who is not of childbearing potential or The patient, and their partner(s), agree to use medically-accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study and for at least 6 weeks after termination of study therapy
4. Ability to provide informed consent signed by the study patient or legally authorised representative.

Exclusion Criteria

1. Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale
2. Any patient whose interests are not best served by study participation, as determined by a senior attending clinician
3. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit of normal (ULN)
4. Known active infection with HIV or hepatitis B or C
5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate <30 ml/min/1.73 m²)
6. History of the following cardiac conditions:
6.1. Myocardial infarction within 3 months prior to the first dose
6.2. Unstable angina
6.3. History of clinically significant dysrhythmias (long QT features on electrocardiogram [ECG], sustained bradycardia [=55 bpm]), left bundle branch block, cardiac pacemaker or ventricular arrhythmia) or history of familial long QT
7. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) > 500 ms
8. Anticipated transfer to another hospital that is not a study centre within 72 hours
9. Allergy to any study medication
10. Experimental off-label usage of medicinal products as treatments for COVID-19
11. Patients participating in another clinical study of an investigational medicinal product

Sub-protocol for candidate agent Bemcentinib:
Additional exclusion criteria that are specific to the subprotocol are as follows:
12. Inability to swallow capsules (administration via nasogastric tube is permitted)
13. Current treatment with any agent known to cause QT prolongation. The treatment can be discontinued, with sufficient time (5 half lives) for washout, to allow inclusion of the patient
14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) >450 ms
15. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once
16. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included.
17. Previous bowel resection that would interfere with drug absorption

Study & Design

• Study Type: Interventional
• Study Design: Not specified