NCT04724395

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

November 30, 2020

Last Update Submit

March 26, 2026

Conditions

COVID-19

Keywords

COVID-19SARS-CoV-2 infectionPost-acute COVID-19DisabilityHealth-related quality of life

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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)

    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)

    36 (±3) months after hospitalization

Secondary Outcomes (34)

  • Type of treatments

    At 12 (±7) and 36 (±3) months after hospitalization

  • Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform)

    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)

    12 (±7) and 36 (±3) months after the first day of the first hospitalization.

  • Pain (questionnaire self-administered on ComPARe IT dedicated platform)

    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)

    12 (±7) and 36 (±3) months after the first day of the first hospitalization.

  • +29 more secondary outcomes

Interventions

HospitalizationOTHER

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People of working-age surviving COVID-19

You may qualify if:

  • Adults of working-age (18 to 70 years),
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Dominic PERENNOU, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • François RANNOU, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

January 26, 2021

Study Start

March 31, 2021

Primary Completion

July 2, 2024

Study Completion

July 2, 2024

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)