Burden of Care of Long COVID Patients After Hospital Discharge

NCT ID: NCT05073328

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68822 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-08-10

Brief Summary

Since March 2020, 3.5 million people have been infected with SARS-COV2 in France, and about 250 000 patients have been hospitalized and successfully discharged.

In a majority of cases, the evolution of the disease is favourable, but both hospitalized or patients with a mild form of the disease may present so called "Long-COVID" syndrome - a patient-created term which describes the effects of COVID-19 that continue for weeks or months beyond the initial symptoms. There is thus an urgent need to evaluate the long-term medical resource utilisation (MRU) and health care burden incurred by patients with Long-COVID, as well as risk factors for Long-COVID.

We will use the SNDS database to extract and analyze the data relevant to the project objectives. Indeed, the SNDS database is the French NHS database providing individual anonymous information of primary and secondary care linked at individual level (data from PMSI, the French DRG-based medical information system). It currently covers more than 98% of the French population.

For the first time, our study will provide an estimation of MRU and associated costs of hospitalized COVID-19 patients. It will also provide an estimation of the rate of long COVID forms developed by hospitalized COVID patients, as well as detailed MRU and costs incurred by long COVID patients compared to patients with non-long COVID-19.

Detailed Description

Since March 2020, 3.5 million people have been infected with SARS-COV2 in France, and about 250 000 patients have been hospitalized and successfully discharged . Currently, the French epidemiological situation shows a stable and high level of new cases of COVID-19 (around 20 000 per day) and associated hospitalizations (around 9 000 per week).

COVID19 may present mild or severe forms, the latter possibly requiring conventional (20%) or intensive care unit (ICU) hospitalization (5%). In most cases, the evolution of the disease is favorable, but both hospitalized or patients with a mild form of the disease may present so called "Long-COVID" syndrome - a patient-created term which describes the effects of COVID-19 that continue for weeks or months beyond the initial symptoms. Persistent symptoms have been described in 5 to 36% of the patients, i.e. symptoms persisting for 4 weeks or more after the onset of the disease. There is growing evidence of the post-COVID-19 chronic syndrome as a postinfectious entity, including but not limited to a range of symptoms ranging from cough and shortness of breath, to fatigue, headache, palpitations, chest pain, joint pain, physical limitations, depression, and insomnia, persisting for longer than two months. This post-COVID chronic syndrome is often called "long COVID". As it is more and more described since the start of the pandemic, the French national health agency (Haute Autorité de Santé, HAS) has recently published specific recommendations for the management of patients presenting long COVID forms.

Although the evidence is still scarce, patients who have been hospitalized for COVID19 may be at higher risk of presenting long COVID. Consequently, they may require more healthcare resource use. As they are easy to identify through administrative databases, we propose to focus on hospitalized and discharged COVID-19 patients with persisting symptoms, in order to investigate their healthcare resource use and corresponding costs, and to compared them to patients not presenting the long COVID form of the disease.

The objectives of this study are:

1. to assess "long-COVID" patients' health care burden (costs) and resource use and to compare them to COVID patients not developing the long form of the disease

2. to identify predictive variables for the development of "long-COVID",

3. to investigate whether different patterns of long-COVID healthcare consumption may be identified.

This will be performed using the Système National des Données de Santé (SNDS) French medico-administrative database.

Conditions

COVID-19; COVID Long

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COVID-19 patients

COVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020

COVID-19 required hospitalisation

Intervention Type: OTHER

Patients who contracted a COVID19 required hospitalisation

sub group The "long COVID" patients

this cohort will include patients with at least 4 weeks of claims and specific health care use after hospital admission from the initial cohort (COVID-19 patients)

According to the Haute Autorité de Santé (HAS), the most frequent symptoms in the context of long COVID are the following :

• Major fatigue
• Dyspnoea, cough
• Chest pain, often tightness type, palpitations
• Problems with concentration and memory, lack of words
• Headache, paraesthesia, burning sensation
• Disorders of smell, taste, tinnitus, dizziness, odynophagia
• Muscle, tendon or joint pain
• Sleep disorders (especially insomnia)
• Irritability, anxiety
• Abdominal pain, nausea, diarrhea, decrease or loss of appetite
• Pruritus, urticaria, pseudo-frostbite
• Fever, chills

COVID-19 required hospitalisation

Intervention Type: OTHER

Patients who contracted a COVID19 required hospitalisation

sub group "non long COVID" patients

all other patients from the initial cohort (COVID-19 patients )

COVID-19 required hospitalisation

Intervention Type: OTHER

Patients who contracted a COVID19 required hospitalisation

Interventions

COVID-19 required hospitalisation

Patients who contracted a COVID19 required hospitalisation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or more
• Patients hospitalized between February 1st and June 30st 2020 for COVID-19 as the main diagnosis, using the following ICD-10 discharge codes: U07.10, U07.11, U07.14, U07.15
• Patients alive at the date of discharge

Exclusion Criteria

• not affiliated to the French Social Security

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PELyon

UNKNOWN

Sponsor Role: collaborator

Mikhail Dziadzko, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Mikhail Dziadzko, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mikhail DZIADZKO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Frederic Aubrun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Eric VAN-GANSE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Pierre ALBALADEJO, MD, PhD

Role: STUDY_CHAIR

CHU Grenoble Alpes

Florence ADER, MD, PhD

Role: STUDY_CHAIR

Hospices Civils de Lyon

Valeria MARTINEZ, MD, PhD

Role: STUDY_CHAIR

Hôpital Raymond-Poincaré - APHP

Claire MARANT-MICALLEF, PharmD, MPH

Role: STUDY_DIRECTOR

PELyon

Manon BELHASSEN, MD, PhD

Role: STUDY_DIRECTOR

PELyon

Fabrice HERITIER, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hopital de la Croix Rousse - Hospices Civils de Lyon

Lyon, , France

Countries

France

References

Dziadzko M, Belhassen M, Van Ganse E, Heritier F, Berard M, Marant-Micallef C, Aubrun F. Health Care Resource Use and Total Mortality After Hospital Admission for Severe COVID-19 Infections During the Initial Pandemic Wave in France: Descriptive Study. JMIR Public Health Surveill. 2024 Sep 11;10:e56398. doi: 10.2196/56398.

Reference Type: DERIVED

PMID: 39259961 (View on PubMed)

Other Identifiers

BLOC-HCL/PELyon

Identifier Type: -

Identifier Source: org_study_id