COVID-19BLOCNCT05073328
Burden of Care of Long COVID Patients After Hospital Discharge
An observational study of COVID-19 and COVID Long, run by Mikhail Dziadzko, MD, PhD at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID Long
- What is being tested?
- COVID-19 required hospitalisation
- How many people
- 68,822 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 10 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult COVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020
Who may be able to join
- 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
Who cannot join
- not affiliated to the French Social Security
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- 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
- to identify predictive variables for the development of "long-COVID",
- 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
- Being tested
- COVID-19 required hospitalisation
- Keywords
- COVID-19, Long COVID, Long-haul COVID-19, post-COVID-19 pain, chronic pain, burden of care, care consomption, national database
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 required hospitalisationOther
Patients who contracted a COVID19 required hospitalisation
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | COVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020 Receives: 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 Receives: Other: COVID-19 required hospitalisation | |
| sub group "non long COVID" patients | all other patients from the initial cohort (COVID-19 patients ) Receives: Other: COVID-19 required hospitalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months following the discharge date
Secondary outcomes (2)
Predictive variables for "long-COVID"
identified risk factors for developing long-COVID
Measured: up to 1 year before the hospitalisation date
Patterns of long-COVID healthcare consumption
typologies of consumption (cluster analyses)
Measured: 6 months following the discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jan 2022
- Primary completion12 Jul 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikhail Dziadzko, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- PELyon
- Responsible party
- Sponsor-investigator, Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse
- Investigators
- Mikhail DZIADZKO, MD, PhD, Principal investigator, Hospices Civils de LyonFrederic Aubrun, MD, PhD, Principal investigator, Hospices Civils de LyonEric VAN-GANSE, MD, PhD, Principal investigator, Hospices Civils de LyonPierre ALBALADEJO, MD, PhD, Study chair, CHU Grenoble AlpesFlorence ADER, MD, PhD, Study chair, Hospices Civils de LyonValeria MARTINEZ, MD, PhD, Study chair, Hôpital Raymond-Poincaré - APHPClaire MARANT-MICALLEF, PharmD, MPH, Study director, PELyonManon BELHASSEN, MD, PhD, Study director, PELyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073328
- Sponsor's protocol ID
- BLOC-HCL/PELyon
- Acronym
- BLOC
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data are protected by the French legislation and are not shared
Publications
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.
PubMed 39259961
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Care of Long COVID Patients After Hospital Discharge
- ClinicalTrials.gov ID
- NCT05073328
- Acronym / sponsor ID
- BLOC / BLOC-HCL/PELyon
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68,822 participants (actual)
- Lead sponsor
- Mikhail Dziadzko, MD, PhDUniversity, hospital or other
- Collaborators
- PELyon
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- to identify predictive variables for the development of "long-COVID",
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Other: COVID-19 required hospitalisationCOVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020 |
| sub group The "long COVID" patients | – | Other: COVID-19 required hospitalisationthis 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 |
| sub group "non long COVID" patients | – | Other: COVID-19 required hospitalisationall other patients from the initial cohort (COVID-19 patients ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult COVID-19 patients discharged from all French hospitals from 01 February to 30 June 2020
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- not affiliated to the French Social Security
- not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 required hospitalisationPatients who contracted a COVID19 required hospitalisation | Other | COVID-19 patients, sub group "non long COVID" patients, sub group The "long COVID" patients |
Primary outcome
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
2 secondary outcomes
Predictive variables for "long-COVID"
Time frame: up to 1 year before the hospitalisation date
Patterns of long-COVID healthcare consumption
Time frame: 6 months following the discharge date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 39259961Dziadzko 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.
- Individual participant dataSharing planned: No. individual participant data are protected by the French legislation and are not shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail DZIADZKO, MD, PhD principal investigator
Hospices Civils de Lyon
Frederic Aubrun, MD, PhD principal investigator
Hospices Civils de Lyon
Eric VAN-GANSE, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and COVID Long, run by Mikhail Dziadzko, MD, PhD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRU (medical resource use ) (time frame: 6 months following the discharge date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.