Burden of Care of Long COVID Patients After Hospital Discharge

NCT05073328 | Completed DMC

• 1 other identifier: BLOC-HCL/PELyon
• Study Type: observational
• Target: 68,822
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; COVID Long

Keywords

COVID-19; Long COVID; Long-haul COVID-19; post-COVID-19 pain; chronic pain; burden of care; care consomption; national database

Outcome Measures

Primary Outcomes (1)

• MRU (medical resource use )

  The primary outcome will be the description of MRU and related costs during the 6 months following the discharge date, i.e.: * medications, * medical, including chronic pain structure consultation/admission, * emergency room visits * paramedical visits (e.g. nurse visits, physiotherapist, psychologist) * specific therapies including pain management, * medical procedures, biological acts * new hospitalizations (for any reason), * sick leaves, * transportation

  6 months following the discharge date

Secondary Outcomes (2)

• Predictive variables for "long-COVID"

  up to 1 year before the hospitalisation date

• Patterns of long-COVID healthcare consumption

  6 months following the discharge date

Study Arms (3)

COVID-19 patients

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

Other: COVID-19 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

Other: COVID-19 required hospitalisation

sub group "non long COVID" patients

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

Other: COVID-19 required hospitalisation

Interventions

COVID-19 required hospitalisation OTHER

Patients who contracted a COVID19 required hospitalisation

COVID-19 patients; sub group "non long COVID" patients; sub group The "long COVID" patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• not affiliated to the French Social Security

Sponsors & Collaborators

• Mikhail Dziadzko, MD, PhD: lead
• PELyon: collaborator

Study Sites (1)

Hopital de la Croix Rousse - Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Publications (1)

• 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.

  PMID: 39259961 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mikhail DZIADZKO, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Frederic Aubrun, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Eric VAN-GANSE, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Pierre ALBALADEJO, MD, PhD

  CHU Grenoble Alpes

  STUDY CHAIR

• Florence ADER, MD, PhD

  Hospices Civils de Lyon

  STUDY CHAIR

• Valeria MARTINEZ, MD, PhD

  Hôpital Raymond-Poincaré - APHP

  STUDY CHAIR

• Claire MARANT-MICALLEF, PharmD, MPH

  PELyon

  STUDY DIRECTOR

• Manon BELHASSEN, MD, PhD

  PELyon

  STUDY DIRECTOR

• Fabrice HERITIER, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 11, 2021
• Study Start: January 1, 2022
• Primary Completion: July 12, 2022
• Study Completion: August 10, 2022
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)