Post-traumatic Stress Disorder Clinical Trial
— COMEBAC 2Official 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
NCT number | NCT04934202 |
Other study ID # | COMEBAC 2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2021 |
Est. completion date | May 5, 2022 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Bicetre hospital | Le Kremlin-Bicêtre |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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 |
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