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

• Conditions: Covid19

• Registration Number: NCT04525911
• Lead Sponsor: Hôpital Européen Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-25
• Study Start: 2020-08-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-08
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
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

Trial Locations

Locations (1)

BENNANI; 🇫🇷 Marseille, France