SARS-COV2REPERCOVNCT04561154
Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV
A study testing questionnaire in people with SARS-COV2 and COVID19, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2020to 11 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient hospitalized for severe Covid-19 infection between March 1 and June 30, 2020 in a conventional unit, intensive care unit, at the Centre hospitalier du Mans and alive at the time of the investigation at 2 to 3 months
- Patient having given their express consent, after having received the research information letter upon discharge from hospital or having given their express consent after sending the information letter
- Age ≥ 18 years
- Patient having contracted a SARS-CoV-2 infection proved by RT-PCR and / or retrospective serology and / or a Covid-19 syndrome with suggestive chest scanner (during the period from March 1, 2020 to June 30, 2020)
Who cannot join
- Patient opposition to participate in the cohort
- Non-French speaking patient
- Patients who cannot read or write
- Patient subject to a protective measure
- Patient not affiliated to a social security or equivalent health insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier du Mans
Le Mans, 72000
Christelle JADEAU, 0243434343 ext. 37482, cjadeau@ch-lemans.fr
Hikombo HITOTO, 0243434343, hhitoto@ch-lemans.fr
About this study
Official title: Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV
Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).
It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.
Read more
Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.
In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.
The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.
- Being tested
- questionnaire
- Keywords
- SARS-COV2, functionnal complaints, sequel
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology
| Study group | Role | What they receive |
|---|---|---|
| patient hospitalized between march 1 and june 30, 2020 | Experimental | patient hospitalized between march 1 and june 30, 2020 Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify functionnal and psychosocial complaints
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Modified Medical Research Council"
Measured: 3 months after last hospitalization
Identify functionnal and psychosocial complaints
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
Measured: 3 months after last hospitalization
Identify functionnal and psychosocial complaints
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria
Measured: 3 months after last hospitalization
Identify functionnal and psychosocial complaints
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Measured: 3 months after last hospitalization
Secondary outcomes (12)
description of functionnal and psychosocial complaints
complaints will be assessed by questionnaire "Modified Medical Research Council"
Measured: 3 months after last hospitalization
description of functionnal and psychosocial complaints
complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
Measured: 3 months after last hospitalization
description of functionnal and psychosocial complaints
complaints will be assessed by FRIED criteria
Measured: 3 months after last hospitalization
description of functionnal and psychosocial complaints
complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Measured: 3 months after last hospitalization
Identify the factors favoring the persistence of complaints
Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization
Measured: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by questionnaire"Modified Medical Research Council"
Measured: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"
Measured: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by FRIED criteria
Measured: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Measured: 3 months after last hospitalization
Describe the needs for medical and surgical consultations after discharge from hospital
Medical and surgical consultations after discharge will be measured as percentage
Measured: 3 months after last hospitalization
Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.
neuropsychological support, dietetics, social assistance after discharge will be measured as percentage
Measured: 3 months after last hospitalization
Describe the factors of inequalities in access to care
Describe the factors of inequalities in access to care and study their impact on the occurrence of a SARS-CoV-2 infection, its severity and the occurrence of a functional or psycho-social complaint.
Measured: 3 months after last hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start11 Jun 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV2Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561154
- Sponsor's protocol ID
- CHM-2020/S10/04
- Acronym
- REPERCOV
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV
- ClinicalTrials.gov ID
- NCT04561154
- Acronym / sponsor ID
- REPERCOV / CHM-2020/S10/04
- Keywords
- SARS-COV2, functionnal complaints, sequel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2022 (estimated)
- First posted
- 23 Sep 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.
Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).
It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.
Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.
In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.
The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient hospitalized between march 1 and june 30, 2020 | Experimental | Other: questionnairepatient hospitalized between march 1 and june 30, 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient hospitalized for severe Covid-19 infection between March 1 and June 30, 2020 in a conventional unit, intensive care unit, at the Centre hospitalier du Mans and alive at the time of the investigation at 2 to 3 months
- Patient having given their express consent, after having received the research information letter upon discharge from hospital or having given their express consent after sending the information letter
- Age ≥ 18 years
- Patient having contracted a SARS-CoV-2 infection proved by RT-PCR and / or retrospective serology and / or a Covid-19 syndrome with suggestive chest scanner (during the period from March 1, 2020 to June 30, 2020)
Key exclusion criteria (5 listed)
- Patient opposition to participate in the cohort
- Non-French speaking patient
- Patients who cannot read or write
- Patient subject to a protective measure
- Patient not affiliated to a social security or equivalent health insurance
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 |
|---|---|---|
| questionnairethree months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology | Other | patient hospitalized between march 1 and june 30, 2020 |
Primary outcome
Identify functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Modified Medical Research Council"
Identify functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
Identify functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria
Identify functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
12 secondary outcomes
description of functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
description of functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
description of functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
description of functionnal and psychosocial complaints
Time frame: 3 months after last hospitalization
Identify the factors favoring the persistence of complaints
Time frame: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Time frame: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Time frame: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Time frame: 3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Time frame: 3 months after last hospitalization
Describe the needs for medical and surgical consultations after discharge from hospital
Time frame: 3 months after last hospitalization
Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.
Time frame: 3 months after last hospitalization
Describe the factors of inequalities in access to care
Time frame: 3 months after last hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with SARS-COV2 and COVID19, run by Centre Hospitalier le Mans 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (0243434343 ext. 37482, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify functionnal and psychosocial complaints (time frame: 3 months after last hospitalization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2022.