Clinical trial NCT04724395: Disability Following Hospitalization in People of Working-age Surviving SARS-CoV-2 Infection - COVID-19
Official title: Prospective Multicenter Cohort Study to Evaluate Disability Following Hospitalization in People of Working-age Surviving COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2 infection
Post-acute COVID-19
Disability
Health-related quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People of working-age surviving COVID-19

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

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)

A. 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.

B. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization
timeFrame: At 12 (±7) months after hospitalization
measure: Post-acute COVID-19 disability from the care provider's perspective, 36 months after hospitalization
timeFrame: 36 (±3) months after hospitalization
measure: Post-acute COVID-19 disability from the patient's perspectives, 12 months after hospitalization
timeFrame: At 12 (±7) months after hospitalization
measure: Post-acute COVID-19 disability from the patient's perspectives, 36 months after hospitalization
timeFrame: 36 (±3) months after hospitalization
Secondary outcomes:
measure: Type of treatments
timeFrame: At 12 (±7) and 36 (±3) months after hospitalization
measure: Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12(±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Health-related quality of life (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Pain (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Impairments, activity limitations and participation restrictions, health-related quality of life Fatigue (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7), and 36 (±3) months after the first day of the first hospitalization.
measure: Urinary symptoms, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Female sexual dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Erectile dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Global activity limitations and participation restrictions (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Work Ability (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Work productivity (questionnaire self-administered on ComPARe IT dedicated platform)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Comorbidities (score completed by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Impairments, activity limitations and participation restrictions (checklist completed by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Mobility test to assess the consequences of neurological, cardiorespiratory, osteoarticular or respiratory impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Locomotor impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Upper extremities impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Respiratory impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Muscular impairments (clinical assessment by the investigator during a face-to-face visit)
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
measure: Total costs
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
measure: Costs drivers
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
measure: Estimated Years lived with Disability
timeFrame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
measure: Burden of post-acute COVID-19 on participant's close relative
timeFrame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
measure: Resource utilization
timeFrame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
measure: Symptoms of anxiety and/or depression of participant's close relative
timeFrame: Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
measure: Symptoms of post-traumatic stress
timeFrame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominic PERENNOU, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: François RANNOU, MD, PhD
role: STUDY_DIRECTOR
References: