NCT04934202

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Sequelae
• Fibrosis
• Post-COVID Syndrome
• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
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
OTHER	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

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2021-06-22
• Last updated: 2021-06-22

Locations

1 site across 1 country: France