HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID)

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

HEAL-COVID is jointly Sponsored by Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge.

The acute effects of COVID-19 are now well described. Evidence is emerging of serious longer-term complications occurring in the convalescent phase of the illness in a significant proportion of patients; particularly cardiovascular and pulmonary complications.

The ill-defined syndrome, "Long COVID" is likely to include a constellation of different conditions traversing post-ICU syndromes, significant cardiopulmonary complications, post-viral syndromes and exacerbations of underlying conditions. Patients have reported a range of longer-term symptoms associated with Long COVID that have significant impacts on their quality of life.

To date, there has been little work evaluating treatments in the convalescent phase of COVID-19. HEAL-COVID aims to evaluate the impact of treatments on longer-term morbidity, mortality, re-hospitalisation, symptom burden and quality of life associated with COVID-19.

The first two treatment arms are Apixaban and Atorvastatin, with further treatment arms to be added at the direction of the UK COVID-19 Therapeutic Advisory Panel (UKCTAP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Cambridge University Hospitals NHS Foundation Trust (joint Sponsor); The University of Cambridge (joint Sponsor); University of Liverpool
• Treatments: Apixaban; Atorvastatin

Criteria

Inclusion criteria:

• greater than or equal to 18 years of age.

• hospitalised with estimated hospital discharge within 5 days.

• SARS-CoV-2 infection associated disease (laboratory confirmed SARS-CoV-2 infection) on this hospital admission.

• written informed consent obtained from participant or participant's legal representative.

Exclusion criteria:

• known hypersensitivity to trial medication (patient will be excluded from specific arm).

• long-term pre-hospital administration of trial medication (patient will be excluded from specific arm).

• previous medical history of significant complication with trial medication or trial medication drug class.

• 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.

• participant not expected to survive 14 days from hospital discharge.

The presence of any of the following will preclude participant inclusion in the Apixaban arm:

• active clinically significant bleeding.

• Childs-Pugh C, or worse, chronic liver disease

• known pregnancy or breast-feeding

• coagulopathy: INR greater than 1.7 or platelet count below 70

• 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.

• 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).

The presence of any of the following will preclude participant inclusion in the Atorvastatin arm:

• Childs-Pugh C, or worse, chronic liver disease

• unexplained persistent elevations of serum transaminases exceeding five times the upper limit of normal.

• known pregnancy or breast-feeding.

• treatment with the hepatitis C antivirals lecaprevir/pibrentasvir, ciclosporin or HIV protease inhibitors.

• serum creatine kinase concentration exceeding 10 times the upper limit of normal.