Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
- Conditions
- SequelaeFibrosisPost-traumatic Stress DisorderPost-COVID Syndrome
- Interventions
- Other: TeleconsultationOther: Outpatient clinic
- Registration Number
- NCT04934202
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.
- Detailed Description
From 15th July to 18th September, 2020, in a first uncontrolled cohort study (Multi-Expertise Consultation of Bicêtre After Covid-19, COMEBAC), we evaluated at four months the surviving patients who were hospitalized at the Bicêtre hospital for COVID-19 during the 1st wave of the epidemic in France and having survived this hospitalization. This cohort included 478 patients. The article resulting from the analysis of the data collected is accepted for publication in JAMA.
This evaluation, the aim of which was both clinical and scientific, was carried out largely thanks to human and material resources then demobilized because of the epidemic and thanks to the investment of doctors and psychologists who carried out the work in addition to their usual work.
The response to the current call for projects aims to bring together the means to continue this monitoring work during the 2nd epidemic wave, while the means and staff are this time completely mobilized by the care of patients with COVID-19 and other. It also aims to raise funds that will allow an in-depth analysis of the residual symptoms presented by the patients.
The current project aims to continue the work started with the COMEBAC "1st wave" cohort with:
* The inclusion of patients hospitalized after the 1st wave.
* An assessment of symptoms according to the SARS-CoV-2 variant.
* A 12-month follow-up of symptomatic patients during the evaluation in COMEBAC "1st wave".
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients from the 1st epidemic wave Outpatient clinic One year after their discharge from the initial hospitalization, patients who presented symptoms during the evaluation in COMEBAC "1st wave" in summer 2020 will benefit from a telephone assessment on the same schedule as that detailed above. If symptoms persist, they will be called to the day hospital for an assessment similar to the one detailed above. Patients from the 1st epidemic wave Teleconsultation One year after their discharge from the initial hospitalization, patients who presented symptoms during the evaluation in COMEBAC "1st wave" in summer 2020 will benefit from a telephone assessment on the same schedule as that detailed above. If symptoms persist, they will be called to the day hospital for an assessment similar to the one detailed above. Patients from the 2nd epidemic wave Teleconsultation As during the evaluation carried out during the 1st wave, the detection of persistent symptoms will be done in two stages: * During a teleconsultation, to which all eligible patients will be invited, systematically looking for general, neurological, cognitive and respiratory symptoms * During a hospitalization in an outpatient clinic to which all survivors who have stayed in an intensive care unit (ICU) will be invited and, among patients who have not stayed in an ICU, those who have residual symptoms detected during the teleconsultation. Patients from the 2nd epidemic wave Outpatient clinic As during the evaluation carried out during the 1st wave, the detection of persistent symptoms will be done in two stages: * During a teleconsultation, to which all eligible patients will be invited, systematically looking for general, neurological, cognitive and respiratory symptoms * During a hospitalization in an outpatient clinic to which all survivors who have stayed in an intensive care unit (ICU) will be invited and, among patients who have not stayed in an ICU, those who have residual symptoms detected during the teleconsultation.
- Primary Outcome Measures
Name Time Method Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19. 6 months nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization
- Secondary Outcome Measures
Name Time Method Association between residual symptoms and the type of SARS-CoV-2 variant 6 months residual symptoms of COVID-19 according to the SARS-CoV-2 variants responsible
Prevalence of respiratory, neurological, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19 which occurred during the 1st epidemic wave. 6 months residual symptoms of COVID-19 one year after COVID-19 that occurred during the 1st epidemic wave
Association between patient characteristics and the prevalence of residual symptoms. 6 months effect of the therapeutic changes that occurred between the 1st and 2nd wave of COVID-19 on these persistent symptoms.
Difference between the prevalence of residual symptoms between patients hospitalized during the 1st wave of the epidemic in France (from the COMEBAC "1st wave" study) and those of the current study 6 months risk factors for the various sequelae of COVID-19
Trial Locations
- Locations (1)
Bicetre hospital
🇫🇷Le Kremlin-Bicêtre, France