Clinical trial NCT04934202: Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
Official title: Cohort Follow-up at 6-12 Months of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic From a University Hospital in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sequelae
Fibrosis
Post-COVID Syndrome
Post-traumatic Stress Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the 1st epidemic wave Patients from the 2nd epidemic wave

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".

Eligibility criteria: For the 6-month evaluation of patients from the 2nd epidemic wave

* Inclusion criteria

  * Age ≥18 years old
  * COVID-19 defined either by a reverse transcriptase-polymerase chain reaction (RT-PCR) or by a combination of clinical signs and compatible lung CT scan
  * Hospitalization for COVID-19 after 1st July 2020
  * Living out of the hospital
* Exclusion criteria

  * Death occurring between index hospitalization and reassessment
  * Patient refusal
  * Discovery of a positive RT-PCR for SARS-CoV-2 during hospitalization for a reason other than COVID-19
  * Nosocomial COVID-19

For the 12-month evaluation of patients from the 1st epidemic wave

* Inclusion criteria

  ◌ Presence of general, cognitive, psychological and respiratory symptoms during the assessment made at 4 months in COMEBAC "1st wave"
* Exclusion criteria

  * Death occurring between the evaluation in COMEBAC "1st wave" and the re-evaluation
  * Patient refusal

Primary outcomes:
measure: Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: Association between patient characteristics and the prevalence of residual symptoms.
timeFrame: 6 months
measure: Association between residual symptoms and the type of SARS-CoV-2 variant
timeFrame: 6 months
measure: Prevalence of respiratory, neurological, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19 which occurred during the 1st epidemic wave.
timeFrame: 6 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicetre hospital
Study officials:
affiliation: Bicêtre Hospital
name: Tai PHAM
role: PRINCIPAL_INVESTIGATOR
References: