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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Diagnostic Test: serology test for COVID-19

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13003
    • BENNANI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; a serology test will be performed at M3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from M3 score measuring anxiety (HAD-A) and depression score (HAD-D) to M12 and M24 for patients and caregivers.	HAD-A score measuring anxiety (example "I feel tense or nervous") and HAD-D score for depression (example "I have the impression of operating in slow motion").; 7 or less: no symptoms; 8 to 10: doubtful symptomatology; 11 and more: definite symptomatology.	12 and 24 months
Change from M3 in the B-IPQ score at M12 and M24 for patients and caregivers.	The Brief Illness Perception Questionnaire (B-IPQ) includes 9 items that assess different components of "perception of the disease"( score 0 to 10 for each items)	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
Evaluation of the fatigue EVA score and quality of life (SF36) at M6 and M12	score from 0 to 10 (0 not tired, 10 max tired)	6 and 12 months

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille
• Investigators: Principal Investigator: Hervé PEGLIASCO, Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2020
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (ACTUAL): August 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020- A01647-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No