REHCOVER: REassessement After Hospitalization for Sars-COV-2 disordER
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Assessment of dyspnea [3 to 6 months after Sars coV 2 infection]
assessed by 0-10 Borg scale
- Description of pulmonary lesions as assessed by lung CT scan [3 to 6 months after Sars coV 2 infection]
assessed by lung CT scan
- 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 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
- 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: depression [3 to 6 months after Sars coV 2 infection]
assessed by validated scales: Patient Health Questionnaire-9 (PHQ9)
- 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)
- 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
- 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 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
- 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)
- Determination of risk factors associated with sequelae or comorbidities [3 to 6 months after Sars coV 2 infection]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital of Montpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL20_0340