Cohort Follow-up of Survivors of Hospitalization for COVID-19 During

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04934202
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Tai PHAM
Phone	+33145217245
Email	tai.pham@aphp.fr
Status	Recruiting
Phase
Start date	May 5, 2021
Completion date	May 5, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms