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Burden of Care of Long COVID Patients After Hospital Discharge (BLOC)

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ClinicalTrials.gov Identifier: NCT05073328
Recruitment Status : Not yet recruiting
First Posted : October 11, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
PELyon
Information provided by (Responsible Party):
Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse

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.


Condition or disease Intervention/treatment
COVID-19 COVID Long Other: COVID-19 required hospitalisation

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.

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Study Type : Observational
Estimated Enrollment : 250000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Burden of Care of Long COVID Patients After Hospital Discharge
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID-19 patients
COVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020
Other: COVID-19 required hospitalisation
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
Other: COVID-19 required hospitalisation
Patients who contracted a COVID19 required hospitalisation

sub group "non long COVID" patients
all other patients from the initial cohort (COVID-19 patients )
Other: COVID-19 required hospitalisation
Patients who contracted a COVID19 required hospitalisation




Primary Outcome Measures :
  1. MRU (medical resource use ) [ Time Frame: 6 months following the discharge date ]

    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


Secondary Outcome Measures :
  1. Predictive variables for "long-COVID" [ Time Frame: up to 1 year before the hospitalisation date ]
    identified risk factors for developing long-COVID

  2. Patterns of long-COVID healthcare consumption [ Time Frame: 6 months following the discharge date ]
    typologies of consumption (cluster analyses)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult COVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020
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
  • not meeting inclusion criteria

Information from the National Library of Medicine

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): NCT05073328


Contacts
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Contact: Manon BELHASSEN, MD, PhD +33 4 81 09 96 07 manon.belhassen@pelyon.fr
Contact: Mikhail DZIADZKO, MD, PhD +33 4 26 10 93 25 mikhail.dziadzko@chu-lyon.fr

Sponsors and Collaborators
Mikhail Dziadzko, MD, PhD
PELyon
Investigators
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Principal Investigator: 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
Study Chair: 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 Director: Claire MARANT-MICALLEF, PharmD, MPH PELyon
Study Director: Manon BELHASSEN, MD, PhD PELyon
Principal Investigator: Fabrice HERITIER, MD Hospices Civils de Lyon
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Responsible Party: Mikhail Dziadzko, MD, PhD, Principal Investigator, Hôpital de la Croix-Rousse
ClinicalTrials.gov Identifier: NCT05073328    
Other Study ID Numbers: BLOC-HCL/PELyon
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data are protected by the French legislation and are not shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse:
COVID-19
Long COVID
Long-haul COVID-19
post-COVID-19 pain
chronic pain
burden of care
care consomption
national database
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases