Helping alleviate the longer-term consequences of COVID-19

Not Applicable

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

• Registration Number: ISRCTN15851697
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-21
• Last Update Posted: 29 January 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1245

Inclusion Criteria

1. Greater than or equal to 18 years of age
2. Hospitalised patient approaching the end of their admission (estimated planned discharge at any point within the next 5 days)
3. SARS-CoV-2 infection-associated disease (laboratory-confirmed SARS-CoV-2 infection on this hospital admission)
4. Written informed consent obtained from participant or participant’s legal representative

Exclusion Criteria

Generic exclusion criteria:
1. Known hypersensitivity to trial medication (patient will be excluded from specific arm)
2. Long-term pre-hospital administration of trial medication (patient will be excluded from specific arm
3. Previous medical history of significant complication with trial medication or trial medication drug class
4. Medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial.
5. Participant not expected to survive 14 days from hospital discharge

Apixaban exclusion criteria:
1. Active clinically significant bleeding
2. Childs-Pugh C, or worse, chronic liver disease
3. Known pregnancy or breast-feeding
4. Coagulopathy: INR greater than 1.7 or platelet count below 70
5. Lesion or condition considered by the investigator as a significant risk factor for major bleeding. This may include recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities
6. Concomitant treatment following discharge with any other anticoagulant agent, including but not limited to unfractionated heparin, low molecular weight heparins (e.g. enoxaparin, dalteparin), heparin derivatives (e.g. fondaparinux), and other oral anticoagulants (e.g. warfarin, rivaroxaban, dabigatran

Atorvastatin exclusion criteria:
1. Childs-Pugh C, or worse, chronic liver disease
2. Unexplained persistent elevation of serum transaminases exceeding five times the upper limit of normal
3. Known pregnancy or breast-feeding.
4. Treatment with the hepatitis C antivirals glecaprevir/pibrentasvir. Ciclosporin, or HIV protease inhibitors
5. Serum creatine kinase concentration exceeding 10 times the upper limit of normal.
6. Long-term pre-hospital administration of any statin therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital-free survival collected via linkage to electronic health records or case report form up to 12 months after randomisation.