REassessement After Hospitalization for Sars-COV-2 disordER

Study Overview
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Brief Summary
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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
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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.

Official Title
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REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization

Conditions
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Sars-CoV2

Intervention / Treatment
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* Other: assessment of the sequelae after hospitalization for Sars-COV-2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: assessment of the sequelae after hospitalization for Sars-COV-2|the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comorbidities, Sars-CoV2, sequelae, patient outcome assessment, Covid19, quality of life