Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital

Hôpital Européen Marseille1 site in 1 country214 target enrollmentAugust 26, 2020

ConditionsCovid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: Hôpital Européen Marseille
Enrollment: 214
Locations: 1
Primary Endpoint: Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.

Registry

clinicaltrials.gov

Start Date

August 26, 2020

End Date

October 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hôpital Européen Marseille

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged ≥ 18 years,
•Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria),
•Having given free and informed written consent,
•Being affiliated with or benefiting from a social security scheme.
•Patients / caregivers may be included in several ancillary studies at the same time.

Exclusion Criteria

•Subject to a measure for the protection of justice

Outcomes

Primary Outcomes

Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers

Time Frame: 3 months

measure used to assess symptoms of post-traumatic stress disorder. Individuals should rate their experience with each of the 17 symptoms of PTSD on a scale of 1 to 5 (1 = not at all, 2 = a little, 3 = moderately, 4 = a little, and 5 = extremely) versus to a specific traumatic event

Secondary Outcomes

Comparison of M0 chest CT results at each follow-up for the entire study population(24 months)
Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers(12 and 24 months)
% of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)(3 months)
Change from M3 in the score of the mental (MCS), physical (PCS) components and the scores of the individual domains of the questionnaire SF36 to M12 and M24 for the entire study population(12 and 24 months)