Status:
UNKNOWN
HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID)
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Liverpool
Cambridge University Hospitals NHS Foundation Trust (joint Sponsor)
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 s...
Detailed Description
BACKGROUND: In December 2019, a cluster of patients with pneumonia of unknown cause was described in Wuhan, China. Named SARS-CoV-2 due to its resemblance to the coronavirus responsible for severe acu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
2631 Patients enrolled
Trial Details
Trial ID
NCT04801940
Start Date
May 19 2021
End Date
January 31 2024
Last Update
July 23 2021
Active Locations (1)
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1
Addenbrookes Hospital
Cambridge, United Kingdom