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Status unknownNCT04561154REPERCOVUpdated Mar 9, 2022

Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV

An interventional study of questionnaire in SARS-COV2 and COVID19, sponsored by Centre Hospitalier le Mans. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • SARS-COV2
  • COVID19

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Keywords

  • SARS-COV2
  • functionnal complaints
  • sequel
03

In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's planned enrollment of 134 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    patient hospitalized between march 1 and june 30, 2020

    patient hospitalized between march 1 and june 30, 2020

    Other: questionnaire

Interventions

  • Otherquestionnaire

    three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: 3 months after last hospitalization

  2. 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)"

    Time frame: 3 months after last hospitalization

  3. 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

    Time frame: 3 months after last hospitalization

  4. 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)"

    Time frame: 3 months after last hospitalization

Secondary outcomes

  1. description of functionnal and psychosocial complaints

    complaints will be assessed by questionnaire "Modified Medical Research Council"

    Time frame: 3 months after last hospitalization

  2. description of functionnal and psychosocial complaints

    complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"

    Time frame: 3 months after last hospitalization

  3. description of functionnal and psychosocial complaints

    complaints will be assessed by FRIED criteria

    Time frame: 3 months after last hospitalization

  4. description of functionnal and psychosocial complaints

    complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"

    Time frame: 3 months after last hospitalization

  5. Identify the factors favoring the persistence of complaints

    Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization

    Time frame: 3 months after last hospitalization

  6. Describe functional, neuropsychological and social complaints at a distance

    Complaints will be assessed by questionnaire"Modified Medical Research Council"

    Time frame: 3 months after last hospitalization

  7. Describe functional, neuropsychological and social complaints at a distance

    Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"

    Time frame: 3 months after last hospitalization

  8. Describe functional, neuropsychological and social complaints at a distance

    Complaints will be assessed by FRIED criteria

    Time frame: 3 months after last hospitalization

  9. Describe functional, neuropsychological and social complaints at a distance

    Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"

    Time frame: 3 months after last hospitalization

  10. Describe the needs for medical and surgical consultations after discharge from hospital

    Medical and surgical consultations after discharge will be measured as percentage

    Time frame: 3 months after last hospitalization

  11. 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

    Time frame: 3 months after last hospitalization

  12. 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.

    Time frame: 3 months after last hospitalization

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2020 to primary completion in Jun 2021, 12 months.

Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 12 months is above that.

Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2020
First posted
Sep 23, 2020
StartActual
Jun 11, 2020
Primary completionActual
Jun 11, 2021
CompletionEst.
Jun 11, 2022
Last update
Mar 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04561154
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Sep 23, 2020
Start date
Jun 11, 2020
Primary completion
Jun 11, 2021
Completion
Jun 11, 2022 (estimated)
Last update
Mar 9, 2022

Study contacts

Christelle JADEAU
Contact
cjadeau@ch-lemans.fr
0243434343 ext. 37482
Hikombo HITOTO
Contact
hhitoto@ch-lemans.fr
0243434343

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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