Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France

• Conditions: Sequelae; Fibrosis; Post-traumatic Stress Disorder; Post-COVID Syndrome

• 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".

Study Timeline

• Study Start: 2021-05-05
• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-22
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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