HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID) (HEAL-COVID)
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|ClinicalTrials.gov Identifier: NCT04801940|
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : July 23, 2021
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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).
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Apixaban Drug: Atorvastatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2631 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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).|
|Masking:||None (Open Label)|
|Official Title:||HElping Alleviate the Longer-term Consequences of COVID-19 (HEAL-COVID): a National Platform Trial|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||January 31, 2024|
No Intervention: Standard Care
Participant receives usual post-hospital care.
Active Comparator: Apixaban
Intervention: Drug: Apixaban.
Apixaban 2.5mg orally twice daily for 14 days.
Other Name: Elquis
Active Comparator: Atorvastatin
Intervention: Drug: Atorvastatin.
Atorvastatin 40mg orally once daily for 12 months.
- Hospital free survival. [ Time Frame: 12 months. ]
- All-cause mortality [ Time Frame: 12 months ]
- Hospital readmission after discharge from index hospital admission [ Time Frame: 12 months ]
- Suspected Serious Adverse Reactions [ Time Frame: 12 months ]
- FACIT-Fatigue [ Time Frame: 12 months ]The Functional Assessment of Chronic Illness Therapy -Fatigue Scale (FACIT-Fatigue) is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. It has been validated for use across a range of populations. The FACIT-Fatigue has a 7-day recall period and is scored on a 5-point Likert Scale from "0-Not at all"- to "4-Very much". Individual items scores are summed (2 items of are reversed scored), multiplied by 13 and then divided by the number of items answered with a higher score indicating less fatigue and better quality of life.
- Modified MRC Dyspnoea Scale [ Time Frame: 12 months ]The modified Medical Research Council (MRC) Dyspnoea Scale is a modification to the widely used MRC Dyspnoea scale. The item has a 24-hour recall period and is scored on a 5-point Likert scale from "0 - I only get breathless with strenuous exercise" to "4 - I was breathless when dressing, talking or at rest". It is a new measure developed specifically for COVID-19 trials, but has a high degree of conceptual overlap with its parent clinical measure, the MRC Dyspnoea scale, which is in widescale clinical practice.
- COVID-19 core outcome measure for recovery [ Time Frame: 12 months ]The COVID-19 core outcome measure for recovery is a single item intending to measure a return to the pre-illness state. The item has a same day recall period and is scored on a 5-point Likert scale from "0 - Completely recovered" to "5 - Not recovered at all". It is a new measure developed specifically for COVID-19 trials, but is similar to widely used global clinical impression scales common to many clinical trials.
- Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: 12 months ]The PHQ-2 is a screening tool for depression derived from the PHQ-9. It comprises the first 2 items of the PHQ-9 (depressed mood and anhedonia). The PHQ-2 has a recall period of 2 weeks. It has a global score (0-6, no weighting). A higher score indicates increased likeliness of underlying depressive disorder. The recommended cut-off score for further investigation is ≥ 3. The PHQ-2 has been validated in many studies and has shown sensitivity of 83% and specificity of 92%.
- Generalized Anxiety Disorder-2 (GAD-2) [ Time Frame: 12 months ]The GAD-2 is a screening tool for generalised anxiety disorder derived from the GAD-7. It comprises the first 2 items of the GAD-7, which are considered as the core anxiety symptoms ("feeling nervous, anxious or on edge"/Not being able to stop or control worrying"). The GAD-2 performs well as a screening tool for three other common anxiety disorders (panic disorder, social anxiety disorder, and PTSD). It has a recall period of two weeks. The GAD-2 has a global score (0-6, no weighting). A higher score indicates increased likeliness of underlying anxiety disorder. The recommended cut-off score for further investigation is ≥ 3. The GAD-2 has been validated in many studies and has retained the same psychometrics properties of the GAD-7 (86% sensitivity/83% specificity).
- PTSD Checklist (PCL-2) [ Time Frame: 12 months ]The PCL-2 is an abbreviated version of the PTSD Checklist - Civilian version (PCL-C) and is used to screen people for PTSD. It comprises 2 items (intrusive memories/distress associated with reminders of the traumatic event). It has a recall period of one month. An individual is considered to have screened positive if the sum of these two items is ≥ 4. Previous studies have shown that the PCL-2 has good psychometric properties and have shown sensitivity of 0.97 and specificity of 0.58.
- Quality of life using the EQ5D-5L [ Time Frame: 12 months ]The Euroqol EQ-5D-5L comprises 5 items plus 1 visual analogue scale. It has been widely validated across a range of diseases and used to assess health outcome from a wide variety of interventions on a common scale, for purposes of evaluation, allocation and monitoring. It is used by the National Institute for Health and Care Excellence (NICE) in health technology assessment. EQ-5D-5L, takes only a few minutes to complete and has a same day recall period. Utilities may be estimated from responses to the EQ-5D-5L, and applying the 3L cross-walk value set.
- Intervention tolerability using the FACT-GP5 [ Time Frame: 12 months ]The single FACT-G item, GP5, "I am bothered by side effects of treatment," is a summary measure of the overall impact of treatment, based upon its association with the number and degree of adverse events in clinical trials. The single item has demonstrated a significant relationship to overall quality of life as indicated by ability to enjoy life. It has a 7-day recall period and is scored on a 5-point Likert Scale from "0-Not at all"- to "4-Very much".
- Additional disease specific systemic symptoms [ Time Frame: 12 months ]Additional disease specific symptomatic questions are informed by data from the Office for National Statistics (ONS) and the Long-COVID research group (https://patientresearchcovid19.com).
- Incremental cost-effectiveness [ Time Frame: 12 months. ]From the perspective of healthcare resource use and based on quality-adjusted life years estimated from responses to the EQ-5D-5L.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801940
|Contact: HEAL-COVID Team||+44 (0) 151 794 email@example.com|
|Cambridge, United Kingdom|
|Contact: Charlotte Summers|
|Principal Investigator:||Charlotte Summers||University of Cambridge|
|Responsible Party:||HEAL-COVID Trial Team, Trial Manager, Cambridge University Hospitals NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||March 17, 2021 Key Record Dates|
|Last Update Posted:||July 23, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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