Sars-CoV2REHCOVERNCT04443257
REassessement After Hospitalization for Sars-COV-2 disordER
An observational study of Sars-CoV2, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- assessment of the sequelae after hospitalization for Sars-COV-2
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2020to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier University Hospital
Who may be able to join
- patient who was hospitalized within 3 to 6 months for a sars-CoV infection
Who cannot join
- Absence of signed informed consent
- pregnancy or breastfeeding
- patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sars-CoV2
- Being tested
- assessment of the sequelae after hospitalization for Sars-COV-2
- Keywords
- comorbidities, Sars-CoV2, sequelae, patient outcome assessment, Covid19, quality of life
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of the sequelae after hospitalization for Sars-COV-2Other
the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry
Measured: 3 to 6 months after Sars coV 2 infection
Secondary outcomes (18)
Assessment of dyspnea
assessed by 0-10 Borg scale
Measured: 3 to 6 months after Sars coV 2 infection
Description of pulmonary lesions as assessed by lung CT scan
assessed by lung CT scan
Measured: 3 to 6 months after Sars coV 2 infection
Development of pulmonary fibrosis as assessed by lung CT scan
assessed by lung CT scan
Measured: 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
Measured: 3 to 6 months after Sars coV 2 infection
Incidence or worsening of renal disease
renal function and urinary parameters
Measured: 3 to 6 months after Sars coV 2 infection
Incidence or worsening of liver disease
hepatic blood parameters
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 to 6 months after Sars coV 2 infection
Incidence or worsening of psychological pathology: insomnia
assessed by validated scale : insomnia severity index (ISI)
Measured: 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)
Measured: 3 to 6 months after Sars coV 2 infection
Assessment of the fatigue
assessed by the fatigue severity sale
Measured: 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
Measured: 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
Measured: 3 to 6 months after Sars coV 2 infection
Development of auto-immune disorders
assessed by lupus anticoagulant, anti-cardiolipin, anti-β2-glycoprotein
Measured: 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
Measured: 3 to 6 months after Sars coV 2 infection
Patients' self-reported level of physical activity
assessed by the International Physical Activity Questionnaire (IPAQ)
Measured: 3 to 6 months after Sars coV 2 infection
Determination of risk factors associated with sequelae or comorbidities
Measured: 3 to 6 months after Sars coV 2 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start8 Jul 2020
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Why it stopped: not enough inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443257
- Sponsor's protocol ID
- RECHMPL20_0340
- Acronym
- REHCOVER
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon a reasonable request
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.
PubMed 36769648
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization
- ClinicalTrials.gov ID
- NCT04443257
- Acronym / sponsor ID
- REHCOVER / RECHMPL20_0340
- Conditions
- Sars-CoV2
- Keywords
- comorbidities, Sars-CoV2, sequelae, patient outcome assessment, Covid19, quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough inclusions
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier University Hospital
Key inclusion criteria (1 listed)
- patient who was hospitalized within 3 to 6 months for a sars-CoV infection
Key exclusion criteria (3 listed)
- Absence of signed informed consent
- pregnancy or breastfeeding
- patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of the sequelae after hospitalization for Sars-COV-2the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases | Other | – |
Primary outcome
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
18 secondary outcomes
Assessment of dyspnea
Time frame: 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
Development of pulmonary fibrosis as assessed by lung CT scan
Time frame: 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
Incidence or worsening of renal disease
Time frame: 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
Incidence or worsening of psychological pathology : anxiety
Time frame: 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
Incidence or worsening of psychological pathology: post-traumatic stress
Time frame: 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
Assessment of the health-related quality of life
Time frame: 3 to 6 months after Sars coV 2 infection
Assessment of the fatigue
Time frame: 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
development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition
Time frame: 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
Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile
Time frame: 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
Determination of risk factors associated with sequelae or comorbidities
Time frame: 3 to 6 months after Sars coV 2 infection
Results and safety
The study was stopped early (reason given: not enough inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Results publication: PubMed 36769648Berger 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.
- Individual participant dataSharing planned: Yes. Data will be made available upon a reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.