REassessement After Hospitalization for Sars-COV-2 disordER

Terminated

• Conditions: Sars-CoV2

• Registration Number: NCT04443257
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2 infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

Detailed Description

Since sars-cov-2 ("CoVID-19") is a newly defined infection, its sequelae and short-term medical and psychological impact remain poorly described.The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

Indeed, some patients may develop chronic respiratory failure, pulmonary fibrosis, or other comorbidities including cardiovascular or metabolic diseases. The psychological impact is also essential to assess. The sequelae and comorbidities of patients could also vary depending on the severity of the initial acute involvement.

Investigators propose to explore the sequelae of patients who have been hospitalized for acute sars-cov-2 infection, between 3 to 6 months after discharge from hospital, by characterizing the incidence of chronic respiratory failure and fibrosis, as well as of various comorbidities such as cardiovascular, metabolic, and psychological diseases.

Study Timeline

• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Study Start: 2020-07-08
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• patient who was hospitalized within 3 to 6 months for a sars-CoV infection

Exclusion Criteria

• Absence of signed informed consent
• pregnancy or breastfeeding
• patient under guardianship or curatorship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry	3 to 6 months after Sars coV 2 infection

Secondary Outcome Measures

Name	Time	Method
Incidence or worsening of renal disease	3 to 6 months after Sars coV 2 infection	renal function and urinary parameters
Incidence or worsening of liver disease	3 to 6 months after Sars coV 2 infection	hepatic blood parameters
Assessment of dyspnea	3 to 6 months after Sars coV 2 infection	assessed by 0-10 Borg scale
Development of pulmonary fibrosis as assessed by lung CT scan	3 to 6 months after Sars coV 2 infection	assessed by lung CT scan
Incidence or worsening of cardiovascular diseases	3 to 6 months after Sars coV 2 infection	assessed by incidence of cardiovascular events, venous thromboembolism, and transthoracic echocardiogram
Incidence or worsening of psychological pathology : anxiety	3 to 6 months after Sars coV 2 infection	assessed by validated scale: Generalized Anxiety Disorder-7 (GAD7)
Incidence or worsening of psychological pathology: post-traumatic stress	3 to 6 months after Sars coV 2 infection	assessed by validated scale : Post-traumatic Checklist for DSM-5 (PCL-5)
Determination of risk factors associated with sequelae or comorbidities	3 to 6 months after Sars coV 2 infection
Description of pulmonary lesions as assessed by lung CT scan	3 to 6 months after Sars coV 2 infection	assessed by lung CT scan
Incidence or worsening of psychological pathology: depression	3 to 6 months after Sars coV 2 infection	assessed by validated scales: Patient Health Questionnaire-9 (PHQ9)
Assessment of the socioeconomic deprivation	3 to 6 months after Sars coV 2 infection	assessed by the Evaluation of Deprivation and Inequalities in Health Examination (EPICES) scale
Development of auto-immune disorders	3 to 6 months after Sars coV 2 infection	assessed by lupus anticoagulant, anti-cardiolipin, anti-β2-glycoprotein
Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile	3 to 6 months after Sars coV 2 infection	Presence and levels of anti-SARS-CoV-2 antibodies of IgG, IgA and IgM isotypes
Patients' self-reported level of physical activity	3 to 6 months after Sars coV 2 infection	assessed by the International Physical Activity Questionnaire (IPAQ)
Incidence or worsening of psychological pathology: insomnia	3 to 6 months after Sars coV 2 infection	assessed by validated scale : insomnia severity index (ISI)
Assessment of the health-related quality of life	3 to 6 months after Sars coV 2 infection	assessed by validated scale (EQ-5D-L questionnaire)
Assessment of the fatigue	3 to 6 months after Sars coV 2 infection	assessed by the fatigue severity sale
development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition	3 to 6 months after Sars coV 2 infection	assessed by blood glucose level, HbA1C, lipid blood tests, TSH, T3, T4, antithyroperoxydase antibodies, cortisol, ACTH, renin, aldosteron, albumin level, vitamin D level, iron status, weight changes

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France