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

Covid19 Clinical Trial

— ALCOVID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04525911
• Other study ID #: 2020- A01647-32
• Status: Active, not recruiting
• Start date: August 26, 2020
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Diagnostic Test: serology test for COVID-19
a serology test will be performed at M3

Locations

Country	Name	City	State
France	BENNANI	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Evaluation of the microbiotic signature according to the severity of the disease at M3, M6 and M12		6 and 12 months
Other	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
Primary	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	Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers		12 and 24 months
Secondary	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
Secondary	% of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)		3 months
Secondary	Comparison of M0 chest CT results at each follow-up for the entire study population		24 months