NCT04390126: CLEO-CD

COVID-19 Related Lockdown Effects On Chronic Diseases

Completed Last updated 2 February 2026

What this trial tests

trial testing life questionnaires in Chronic Coronary Syndrome in 1,343 participants. Completed in 2 June 2020.

Timeline

14 April 2020

Primary endpoint
2 June 2020

2 June 2020

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,343
Start date	14 April 2020
Primary completion	2 June 2020
Estimated completion	2 June 2020
Sites	1 location across France

Drugs / interventions tested

• life questionnaires
• questionnaire

Conditions studied

• Chronic Coronary Syndrome — all drugs for Chronic Coronary Syndrome →
• Heart Failure — all drugs for Heart Failure →
• AMD and Macular Edema — all drugs for AMD and Macular Edema →
• Chronic Respiratory Failure — all drugs for Chronic Respiratory Failure →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

9 Months and older, any sex, with Chronic Coronary Syndrome or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term.

Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event.

The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring.

Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Is Acetylsalicylic Acid a Safe and Potentially Useful Choice for Adult Patients with COVID-19 ?
   Bianconi V, Violi F, Fallarino F, Pignatelli P, et al · · 2020 · cited 74× · PMID 32705604 · DOI 10.1007/s40265-020-01365-1
2. Impact of lockdown on patients with congestive heart failure during the coronavirus disease 2019 pandemic.
   Chagué F, Boulin M, Eicher JC, Bichat F, et al · · 2020 · cited 39× · PMID 32997438 · DOI 10.1002/ehf2.13016
3. Neuropsychiatric Disorders and COVID-19: What We Know So Far.
   Majolo F, Silva GLD, Vieira L, Anli C, et al · · 2021 · cited 12× · PMID 34577633 · DOI 10.3390/ph14090933
4. Impact of first COVID-19 lockdown on paediatric and adult haemophilia patients treated in a French Haemophilia Comprehensive Care Centre.
   Volot F, Soudry-Faure A, Callegarin A, Ksiazek E, et al · · 2022 · cited 5× · PMID 35238436 · DOI 10.1111/hae.14526
5. Impact of the COVID-19 lockdown on patients suffering from idiopathic interstitial pneumonia.
   Beltramo G, Cransac A, Favrolt N, Spanjaard M, et al · · 2021 · cited 4× · PMID 33422721 · DOI 10.1016/j.resmer.2020.100808
6. COVID-19 Lockdown in Patients with Chronic Diseases: A Cross-Sectional Study.
   Boulin M, Cransac-Miet A, Maynadié M, Volot F, et al · · 2022 · cited 3× · PMID 35409640 · DOI 10.3390/ijerph19073957
7. Smoking in Patients With Chronic Cardiovascular Disease During COVID-19 Lockdown.
   Chagué F, Boulin M, Eicher JC, Bichat F, et al · · 2022 · cited 2× · PMID 35557527 · DOI 10.3389/fcvm.2022.845439
8. Effets du confinement lié à la COVID-19 chez les patients atteints de maladies chroniques
   Boulin M, Cransac A, Adam H, Vadot L, et al · · 2022