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

NCT04801940 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2631

Last updated 2021-07-23

No results posted yet for this study

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).

Conditions

  • Covid19

Interventions

DRUG

Apixaban

Apixaban 2.5mg orally twice daily for 14 days.

DRUG

Atorvastatin

Atorvastatin 40mg orally once daily for 12 months.

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER
  • Cambridge University Hospitals NHS Foundation Trust (joint Sponsor)

    collaborator UNKNOWN
  • University of Cambridge

    collaborator OTHER
  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Charlotte Summers · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801940 on ClinicalTrials.gov