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

NCT04525911 | Unknown DMC

• 1 other identifier: 2020- A01647-32
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

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

  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

  3 months

Secondary Outcomes (4)

• Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers

  12 and 24 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

• % of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)

  3 months

• Comparison of M0 chest CT results at each follow-up for the entire study population

  24 months

Other Outcomes (4)

• Change from M3 score measuring anxiety (HAD-A) and depression score (HAD-D) to M12 and M24 for patients and caregivers.

  12 and 24 months

• Change from M3 in the B-IPQ score at M12 and M24 for patients and caregivers.

  12 and 24 months

• Evaluation of the microbiotic signature according to the severity of the disease at M3, M6 and M12

  6 and 12 months

Study Arms (1)

Symptomatic COVID-19 infection confirmed or probable

Patients and medical staff having symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria)

Diagnostic Test: Diagnostic Test: serology test for COVID-19

Interventions

Diagnostic Test: serology test for COVID-19 DIAGNOSTIC_TEST

a serology test will be performed at M3

Symptomatic COVID-19 infection confirmed or probable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient and medical staff with confirmed or probable COVID-19 infection

You may qualify if:

• 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.

You may not qualify if:

• Subject to a measure for the protection of justice

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

BENNANI

Marseille, 13003, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hervé PEGLIASCO

  Hôpital Europeen Marseille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 25, 2020
• Study Start: August 26, 2020
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)