NCT04801940

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 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,631

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started May 2021

Longer than P75 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2.7 years

First QC Date

March 12, 2021

Last Update Submit

July 19, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Hospital free survival.

    12 months.

Secondary Outcomes (12)

  • All-cause mortality

    12 months

  • Hospital readmission after discharge from index hospital admission

    12 months

  • Suspected Serious Adverse Reactions

    12 months

  • FACIT-Fatigue

    12 months

  • Modified MRC Dyspnoea Scale

    12 months

  • +7 more secondary outcomes

Other Outcomes (1)

  • Incremental cost-effectiveness

    12 months.

Study Arms (3)

Standard Care

NO INTERVENTION

Participant receives usual post-hospital care.

Apixaban

ACTIVE COMPARATOR

Intervention: Drug: Apixaban.

Drug: Apixaban

Atorvastatin

ACTIVE COMPARATOR

Intervention: Drug: Atorvastatin.

Drug: Atorvastatin

Interventions

ApixabanDRUG

Apixaban 2.5mg orally twice daily for 14 days.

Also known as: Elquis
Apixaban
AtorvastatinDRUG

Atorvastatin 40mg orally once daily for 12 months.

Atorvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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).
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrookes Hospital

Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

apixabanAtorvastatin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Charlotte Summers

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HEAL-COVID Team

CONTACT

+44 (0) 151 794 0222trial.team@heal-covid.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomisation will use equal probability between all active treatments a given patient is eligible for and Standard Care (SC) as the control arm (i.e. a patient that is eligible for two treatments and SC will be randomized 1:1:1 between the three arms).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trial Manager

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 17, 2021

Study Start

May 19, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

At the end of the trial, after the primary results have been published, all requests for access to trial data will be reviewed by the Trial Management Group and where possible access will be granted.

Access Criteria
Proposals for data sharing can be submitted for consideration via contact details on the HEAL-COVID website.
More information

Locations

GB(1)