Sars-CoV2 Clinical Trial
— REHCOVEROfficial title:
REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization
Verified date | February 2023 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 119 |
Est. completion date | February 18, 2022 |
Est. primary completion date | February 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Berger M, Daubin D, Charriot J, Klouche K, Le Moing V, Morquin D, Halimi L, Jaussent A, Taourel P, Hayot M, Cristol JP, Nagot N, Fesler P, Roubille C. Mid-Term Sequelae of Surviving Patients Hospitalized in Intensive Care Unit for COVID-19 Infection: The — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessment of dyspnea | assessed by 0-10 Borg scale | 3 to 6 months after Sars coV 2 infection | |
Secondary | Description of pulmonary lesions as assessed by lung CT scan | assessed by lung CT scan | 3 to 6 months after Sars coV 2 infection | |
Secondary | Development of pulmonary fibrosis as assessed by lung CT scan | assessed by lung CT scan | 3 to 6 months after Sars coV 2 infection | |
Secondary | 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 | |
Secondary | Incidence or worsening of renal disease | renal function and urinary parameters | 3 to 6 months after Sars coV 2 infection | |
Secondary | Incidence or worsening of liver disease | hepatic blood parameters | 3 to 6 months after Sars coV 2 infection | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Incidence or worsening of psychological pathology: insomnia | assessed by validated scale : insomnia severity index (ISI) | 3 to 6 months after Sars coV 2 infection | |
Secondary | 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 | |
Secondary | Assessment of the fatigue | assessed by the fatigue severity sale | 3 to 6 months after Sars coV 2 infection | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Development of auto-immune disorders | assessed by lupus anticoagulant, anti-cardiolipin, anti-ß2-glycoprotein | 3 to 6 months after Sars coV 2 infection | |
Secondary | 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 | |
Secondary | Patients' self-reported level of physical activity | assessed by the International Physical Activity Questionnaire (IPAQ) | 3 to 6 months after Sars coV 2 infection | |
Secondary | Determination of risk factors associated with sequelae or comorbidities | 3 to 6 months after Sars coV 2 infection |
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