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

NCT ID: NCT04724395

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 530 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2024-07-02

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Hospitalization

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominic PERENNOU, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

François RANNOU, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

2020-A02552-37

Identifier Type: OTHER

Identifier Source: secondary_id

P200601

Identifier Type: -

Identifier Source: org_study_id