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

Post-traumatic Stress Disorder Clinical Trial

— COMEBAC 2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934202
• Other study ID #: COMEBAC 2
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: May 5, 2022

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Tai PHAM
• Phone: +33145217245
• Email: tai.pham[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Post-traumatic Stress Disorder
• Sequelae
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Teleconsultation
Teleconsulting physicians will subject patients to a standardized questionnaire that will look for the following symptoms: General signs: Anorexia, fatigue, new hospitalization, weight loss, Respiratory signs: recent dyspnoea, chest discomfort, chest pain, new cough, abnormal lung CT scan since discharge Neurological signs: headache, paraesthesia, anosmia, limb paralysis Digestive signs: abdominal pain, diarrhoea, constipation, nausea, vomiting Edition 2021 ? Cognitive signs using the Q3PC questionnaire (10): memory loss, slowness in reasoning, activity planning or problem solving, concentration, attention difficulties
• Outpatient clinic
During a day hospitalization planned during the teleconsultation, patients will benefit from the following multidisciplinary assessment. General clinical examination Assessment of the state of health Respiratory assessment Pulmonary CT assessment Cognitive evaluation Cardiological evaluation Renal assessment Immunological evaluation

Locations

Country	Name	City	State
France	Bicetre hospital	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.	nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization	6 months
Secondary	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	risk factors for the various sequelae of COVID-19	6 months
Secondary	Association between patient characteristics and the prevalence of residual symptoms.	effect of the therapeutic changes that occurred between the 1st and 2nd wave of COVID-19 on these persistent symptoms.	6 months
Secondary	Association between residual symptoms and the type of SARS-CoV-2 variant	residual symptoms of COVID-19 according to the SARS-CoV-2 variants responsible	6 months
Secondary	Prevalence of respiratory, neurological, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19 which occurred during the 1st epidemic wave.	residual symptoms of COVID-19 one year after COVID-19 that occurred during the 1st epidemic wave	6 months