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

February 16, 2023 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry
Time Frame: 3 to 6 months after Sars coV 2 infection
3 to 6 months after Sars coV 2 infection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of dyspnea
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
assessed by lung CT scan
3 to 6 months after Sars coV 2 infection
Development of pulmonary fibrosis as assessed by lung CT scan
Time Frame: 3 to 6 months after Sars coV 2 infection
assessed by lung CT scan
3 to 6 months after Sars coV 2 infection
Incidence or worsening of cardiovascular diseases
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
renal function and urinary parameters
3 to 6 months after Sars coV 2 infection
Incidence or worsening of liver disease
Time Frame: 3 to 6 months after Sars coV 2 infection
hepatic blood parameters
3 to 6 months after Sars coV 2 infection
Incidence or worsening of psychological pathology : anxiety
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
assessed by validated scale (EQ-5D-L questionnaire)
3 to 6 months after Sars coV 2 infection
Assessment of the fatigue
Time Frame: 3 to 6 months after Sars coV 2 infection
assessed by the fatigue severity sale
3 to 6 months after Sars coV 2 infection
Assessment of the socioeconomic deprivation
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 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
3 to 6 months after Sars coV 2 infection
Development of auto-immune disorders
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
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
Time Frame: 3 to 6 months after Sars coV 2 infection
3 to 6 months after Sars coV 2 infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sars-CoV2

Clinical Trials on assessment of the sequelae after hospitalization for Sars-COV-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings