NCT04714138

Brief Summary

Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities. This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

January 14, 2021

Last Update Submit

August 24, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life

    Measured with the Short-Form health survey (SF-36) scale (score ranging form 0 (worst score) to 100 (best score) per item)

    10 to 12 months after hospital discharge during remote video consultation

Secondary Outcomes (2)

  • Functional capacity

    10 to 12 months after hospital discharge during remote video consultation

  • Independency

    10 to 12 months after hospital discharge during remote video consultation

Eligibility Criteria

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

COVID-19 adults patients hospitalised at Le Havre hospital between March 1st and May 11th

You may qualify if:

  • Adult patient
  • COVID-19 hospitalisation at Le Havre hospital between March 1st and May 11th
  • Non-opposition during first phone contact

You may not qualify if:

  • Guardianship
  • Juvenile patients
  • Pregnancy
  • Inability to communicate
  • Cognitive disorders
  • Deceased patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Du Havre

Montivilliers, Normandy, 76290, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 19, 2021

Study Start

January 5, 2021

Primary Completion

March 20, 2021

Study Completion

June 15, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

FR(1)