Covid19
Conditions
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.
Interventions
DIAGNOSTIC_TESTDiagnostic Test: serology test for COVID-19
a serology test will be performed at M3
Sponsors
Hôpital Européen Marseille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from M3 in the B-IPQ score at M12 and M24 for patients and caregivers. | 12 and 24 months | 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) |
| 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 | 6 and 12 months | score from 0 to 10 (0 not tired, 10 max tired) |
| 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 | 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. |
Countries
France
Outcome results
None listed