REassessement After Hospitalization for Sars-COV-2 disordER

Sars-CoV2 Clinical Trial

— REHCOVER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04443257
• Other study ID #: RECHMPL20_0340
• Status: Terminated
• Start date: July 8, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Sars-CoV2

Intervention

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

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

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