REassessement After Hospitalization for Sars-COV-2 disordER (REHCOVER)

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

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.

Study Overview

• Status: Terminated
• Conditions: Sars-CoV2
• Intervention / Treatment: Other: assessment of the sequelae after hospitalization for Sars-COV-2

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 Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier University Hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Covid19; quality of life; comorbidities; sequelae; Sars-CoV2; patient outcome assessment
• Other Study ID Numbers: RECHMPL20_0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon a reasonable request
• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No