Clinical trial NCT04443257: REassessement After Hospitalization for Sars-COV-2 disordER
Official title: REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sars-CoV2
Keywords: comorbidities
Sars-CoV2
sequelae
patient outcome assessment
Covid19
quality of life
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier University Hospital

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.

Eligibility 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

Primary outcomes:
measure: Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry
timeFrame: 3 to 6 months after Sars coV 2 infection
Secondary outcomes:
measure: Assessment of dyspnea
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Description of pulmonary lesions as assessed by lung CT scan
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Development of pulmonary fibrosis as assessed by lung CT scan
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of cardiovascular diseases
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of renal disease
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of liver disease
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of psychological pathology : anxiety
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of psychological pathology: depression
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of psychological pathology: post-traumatic stress
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Incidence or worsening of psychological pathology: insomnia
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Assessment of the health-related quality of life
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Assessment of the fatigue
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Assessment of the socioeconomic deprivation
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Development of auto-immune disorders
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Patients' self-reported level of physical activity
timeFrame: 3 to 6 months after Sars coV 2 infection
measure: Determination of risk factors associated with sequelae or comorbidities
timeFrame: 3 to 6 months after Sars coV 2 infection
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
citation: 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 REHCOVER Study. J Clin Med. 2023 Jan 28;12(3):1000. doi: 10.3390/jcm12031000.