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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

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

Treatments: Other: Teleconsultation; Other: Outpatient clinic

Study type: Observational

Funder types: Other

Identifiers

NCT04934202

COMEBAC 2

Details and patient eligibility

About

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.

Full 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".

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

500 participants in 2 patient groups

Patients from the 1st epidemic wave

Description:

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.

Treatment:

Other: Outpatient clinic

Other: Teleconsultation

Patients from the 2nd epidemic wave

Description:

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.

Treatment:

Other: Outpatient clinic

Other: Teleconsultation