COVID-19DisCOVIDNCT04724395

Disability Following Hospitalization in People of Working-age Surviving SARS-CoV-2 Infection - COVID-19

An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: COVID-19
What is being tested?: Hospitalization
How many people: 530 participants
Where: 1 siteFrance
Study dates: 31 Mar 2021to 2 Jul 2024
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: People of working-age surviving COVID-19

Who may be able to join

Adults of working-age (18 to 70 years),
Hospitalization during the prespecified inclusion period (from March 2020 to March 2021) (NB : in case of transferred patients, inclusion in the DisCOVID study must be carried out in the first place of admission for COVID),
Laboratory-confirmed SARS-CoV-2 and/or CT-scan showing typical radiological findings,
SARS-CoV-2 of any duration,
Ability to comply with study visits,
Informed written consent

Who cannot join

Return home in less than 72 hours
Absence of health insurance,
Inability to fluently speak and/or read French language,
People under tutorship or curatorship and protected adults.

Trial locations and contacts

1 site in 1 country.

France1 site

Cochin Hospital
Paris, 75014

Other trials in France

About this study

Official title: Prospective Multicenter Cohort Study to Evaluate Disability Following Hospitalization in People of Working-age Surviving COVID-19

The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.

Read the detailed description

In December 2019, the Wuhan Municipal Health Committee in China identified an outbreak with viral pneumonia cases of unknown cause. Coronavirus RNA was identified as the causal agent. The disease caused by SARS-CoV-2 has been named COVID-19. While most people with COVID-19 develop uncomplicated illness, approximately 14% develop severe forms of the disease and 5% are critically ill, potentially leaving survivors with non-fatal sequelae. To date, the long-term burden of COVID-19 and patients' perspectives and needs have been left unaddressed. As compared to 2003 SARS outbreak, one can anticipate persisting disability in COVID-19 survivors, including specific post-COVID and non-specific post-intensive care syndromes. The investigators hypothesize that dramatic COVID-19-specific and non-specific mid- and long-term disabilities would persist in people surviving COVID-19.

The main objective will be to provide a deep understanding of non-fatal health outcomes in people surviving COVID-19, by comprehensively and systematically mapping and monitoring, within the WHO ICF framework, disability levels and profiles, in the mid and long terms in people surviving COVID-19.

Disability levels will be assessed at 12 (±7) and 36 (±3) months using:

Parts 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider, and
Self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

The secondary objectives will be to describe COVID-19 specific and non-specific impairments, activity limitations and participation restriction at 12 (±7) and 36 (±3) months in people surviving COVID-19:

Impairments, participation restrictions and health-related quality of life (HRQoL) at 12 (±7) and 36 (±3) months will be assessed using online specific self-administered questionnaires and face-to-face specific tests.
Non-pharmacological / pharmacological treatments at baseline, 12 (±7) and 36 (±3) months will be self-reported.
Total costs, cost drivers and estimated Years-Lived with Disability (YLDs) at 12 (±7) and (36 (±3) months will be calculated.

Another secondary objective will be to assess the burden of the patient's SARS-CoV-2 infection on the patient's close relative, between M12-inclusion and M36 patient visits.

The burden on patient's close relative will be assessed using specific printed self-administered questionnaires.

Conditions: COVID-19
Being tested: Hospitalization
Keywords: COVID-19, SARS-CoV-2 infection, Post-acute COVID-19, Disability, Health-related quality of life
Medical subject headings: COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HospitalizationOther
Hospitalization in intensive care and non-intensive care units for COVID-19 followed by usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider.
Measured: At 12 (±7) months after hospitalization
Post-acute COVID-19 disability from the care provider's perspective, 36 months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider
Measured: 36 (±3) months after hospitalization
Post-acute COVID-19 disability from the patient's perspectives, 12 months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Measured: At 12 (±7) months after hospitalization
Post-acute COVID-19 disability from the patient's perspectives, 36 months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Measured: 36 (±3) months after hospitalization

Secondary outcomes (34)

Type of treatments
Non-pharmacological / pharmacological treatments will be self-reported : ER consultations, specialist consultations, laboratory tests, new hospital stay, rehabilitation resource consumption
Measured: At 12 (±7) and 36 (±3) months after hospitalization
Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform)
Anchor questions ( 2 questions)
Measured: 12(±7) and 36 (±3) months after the first day of the first hospitalization.
Health-related quality of life (questionnaire self-administered on ComPARe IT dedicated platform)
EuroQol : ED-5D-5L (5 themes of questions + a scale from 0 to 100, 100 is the best state of health)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Pain (questionnaire self-administered on ComPARe IT dedicated platform)
Brief Pain Inventory (7 scales from 0 to 10 : 10 is the worst pain)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life Fatigue (questionnaire self-administered on ComPARe IT dedicated platform)
Modified Fatigue Impact Scale (8 questions)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
Hospital Anxiety and Depression Scale (14 questions with scales from 0 to 3)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
Post-Traumatic Stress Disorder Checklist Scale (17 questions with a scale from 1 to 5)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
Brain Injury Complaint Questionnaire (25 questions)
Measured: 12 (±7), and 36 (±3) months after the first day of the first hospitalization.
Urinary symptoms, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
Urinary Symptom Profile (10 questions)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Female sexual dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
Female Sexual Function Index
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Erectile dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
International Index of Erectile Function (5 questions with a scale from 0 to 5)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Global activity limitations and participation restrictions (questionnaire self-administered on ComPARe IT dedicated platform)
36-Item WHODAS 2.0
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Work Ability (questionnaire self-administered on ComPARe IT dedicated platform)
Work Ability Index Single-Item 1 (1 question with a scale from 0 to 10, 10 is the highest ability to work)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Work productivity (questionnaire self-administered on ComPARe IT dedicated platform)
Work Productivity and Activity Impairment questionnaire Single-Item 5 (1 question with a scale from 0 to 10, 10 is the worst productivity)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Comorbidities (score completed by the investigator during a face-to-face visit)
Charlson comorbidity index (20 items)
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions (checklist completed by the investigator during a face-to-face visit)
WHO ICF checklist v2.1
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Mobility test to assess the consequences of neurological, cardiorespiratory, osteoarticular or respiratory impairments (clinical assessment by the investigator during a face-to-face visit)
6 minute walk test
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Locomotor impairments (clinical assessment by the investigator during a face-to-face visit)
Timed up and go test
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Upper extremities impairments (clinical assessment by the investigator during a face-to-face visit)
Box and Block test
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)
MRC Dyspnoea scale
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)
NYHA grade
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)
Montreal Cognitive Assessment
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)
Frontal Assessment Battery
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
MRC-Sum Score
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Respiratory impairments (clinical assessment by the investigator during a face-to-face visit)
Sustained Expiration while counting
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
Grip strength
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
Chair rise with arms
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Total costs
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Costs drivers
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Estimated Years lived with Disability
Measured: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Burden of post-acute COVID-19 on participant's close relative
Zarit Burden Inventory (22 questions with a scale from 0 to 4) (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Measured: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Resource utilization
Resource Utilization in Dementia - Part I (3 items of questions) (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Measured: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Symptoms of anxiety and/or depression of participant's close relative
Hospital Anxiety and Depression Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Measured: Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
Symptoms of post-traumatic stress
Post-Traumatic Stress Disorder Check-list Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Measured: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20212 Jul 2024

First posted26 Jan 2021
Study start31 Mar 2021
Primary completion2 Jul 2024
Study completion2 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
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: Prospective
Enrolment: 530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04724395
Sponsor's protocol ID: P200601
Other IDs: 2020-A02552-37
Acronym: DisCOVID
Status last verified: Mar 2026
First submitted: 30 Nov 2020
Last updated: 31 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Multicenter Cohort Study to Evaluate Disability Following Hospitalization in People of Working-age Surviving COVID-19
ClinicalTrials.gov ID: NCT04724395
Acronym / sponsor ID: DisCOVID / P200601
Conditions: COVID-19
Keywords: COVID-19, SARS-CoV-2 infection, Post-acute COVID-19, Disability, Health-related quality of life
Study type: Observational
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: URC-CIC Paris Descartes Necker Cochin
Study start: 31 Mar 2021 (actual)
Primary completion: 2 Jul 2024 (actual)
Study completion: 2 Jul 2024 (actual)
First posted: 26 Jan 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.

The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.

Detailed description

Disability levels will be assessed at 12 (±7) and 36 (±3) months using:

Parts 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider, and
Self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

The secondary objectives will be to describe COVID-19 specific and non-specific impairments, activity limitations and participation restriction at 12 (±7) and 36 (±3) months in people surviving COVID-19:

Impairments, participation restrictions and health-related quality of life (HRQoL) at 12 (±7) and 36 (±3) months will be assessed using online specific self-administered questionnaires and face-to-face specific tests.
Non-pharmacological / pharmacological treatments at baseline, 12 (±7) and 36 (±3) months will be self-reported.
Total costs, cost drivers and estimated Years-Lived with Disability (YLDs) at 12 (±7) and (36 (±3) months will be calculated.

Another secondary objective will be to assess the burden of the patient's SARS-CoV-2 infection on the patient's close relative, between M12-inclusion and M36 patient visits.

The burden on patient's close relative will be assessed using specific printed self-administered questionnaires.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: People of working-age surviving COVID-19

Key inclusion criteria (6 listed)

Adults of working-age (18 to 70 years),
Hospitalization during the prespecified inclusion period (from March 2020 to March 2021) (NB : in case of transferred patients, inclusion in the DisCOVID study must be carried out in the first place of admission for COVID),
Laboratory-confirmed SARS-CoV-2 and/or CT-scan showing typical radiological findings,
SARS-CoV-2 of any duration,
Ability to comply with study visits,

Key exclusion criteria (4 listed)

Return home in less than 72 hours
Absence of health insurance,
Inability to fluently speak and/or read French language,
People under tutorship or curatorship and protected adults.

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
HospitalizationHospitalization in intensive care and non-intensive care units for COVID-19 followed by usual care	Other	–

Primary outcome

Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization
Time frame: At 12 (±7) months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider.
Post-acute COVID-19 disability from the care provider's perspective, 36 months after hospitalization
Time frame: 36 (±3) months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider
Post-acute COVID-19 disability from the patient's perspectives, 12 months after hospitalization
Time frame: At 12 (±7) months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Post-acute COVID-19 disability from the patient's perspectives, 36 months after hospitalization
Time frame: 36 (±3) months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

34 secondary outcomes

Type of treatments
Time frame: At 12 (±7) and 36 (±3) months after hospitalization
Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12(±7) and 36 (±3) months after the first day of the first hospitalization.
Health-related quality of life (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Pain (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life Fatigue (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7), and 36 (±3) months after the first day of the first hospitalization.
Urinary symptoms, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Female sexual dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Erectile dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Global activity limitations and participation restrictions (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Work Ability (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Work productivity (questionnaire self-administered on ComPARe IT dedicated platform)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Comorbidities (score completed by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Impairments, activity limitations and participation restrictions (checklist completed by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Mobility test to assess the consequences of neurological, cardiorespiratory, osteoarticular or respiratory impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Locomotor impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Upper extremities impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Respiratory impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Total costs
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Costs drivers
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Estimated Years lived with Disability
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Burden of post-acute COVID-19 on participant's close relative
Time frame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Resource utilization
Time frame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Symptoms of anxiety and/or depression of participant's close relative
Time frame: Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
Symptoms of post-traumatic stress
Time frame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.

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 31 Mar 2026.
Individual participant dataSharing planned: No

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

Dominic PERENNOU, MD, PhD study director

Assistance Publique - Hôpitaux de Paris

François RANNOU, MD, PhD study director

Assistance Publique - Hôpitaux de Paris

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, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 4 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 31 Mar 2026. 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?

Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization (time frame: At 12 (±7) months after hospitalization). The study lists 4 primary outcomes in all. 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 NCT04724395.

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 31 Mar 2026.