Observational Cohort of COVID-19 Patients at Raymond-Poincare (COVID-RPC)
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|ClinicalTrials.gov Identifier: NCT04364698|
Recruitment Status : Unknown
Verified May 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : April 28, 2020
Last Update Posted : May 14, 2020
The SARS-CoV-2 infection detected in China in December 2019 is responsible for the current COVID-19 pandemic affecting nearly 1.2 million people worldwide to date. Infection with this virus of the coronavirus family is causing a broad clinical spectrum, the main manifestation of which is an influenza-like condition associated with a pattern of severe hypoxemia pneumonia, and in some cases fatal. Little is known about this pathology, so we propose to carry out an observational cohort of patients treated in our hospital for an SARS-CoV-2 infection.
This cohort should make it possible to clinically, biologically and radiologically characterize the SARS-CoV-2 infections. We will also collect the therapeutic strategies implemented, their possible toxicity and the evolution of the patients.
|Condition or disease|
COVID-19 is a virus belonging to the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus that caused the current COVID-19 pandemic, although widely described in the literature, still has many grey areas. The main clinical manifestation is an influenza-like illness associated with respiratory tract infection that can lead to severe hypoxemic pneumonia with fatal outcomes in 2.3% of cases. The clinical spectrum is not yet very well known, as evidenced by the evidence of anosmia, agueusia, or recent skin manifestations, but also strong suspicion of possible neurological damage. Similarly, it is not yet very well established, apart from certain co-morbidities, which patients are likely to develop serious forms requiring admission to intensive care, as shown by the proportion of patients < 60 years of age admitted to intensive care for ARDS.
Moreover, the question of how to manage these patients still raises many questions, particularly about the type of molecules to be introduced and at what point in the history of the disease. Some of these molecules, such as the Lopinavir/Ritonavir combinations and the Hydroxychloroquine/ Azithromycin combination, are not free of complications, particularly cardiac complications requiring close monitoring by ECGs and repeated dosing, the effectiveness of which has not yet been clearly demonstrated.
In order to better understand this infection, we propose to set up a cohort of patients treated for CoV-2 SARS infection on our site.
Longitudinal cohort study of patients with confirmed or strongly suspected CoV-2 SARS infection.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Observational Cohort of COVID-19 Patients at Raymond-Poincare|
|Actual Study Start Date :||May 7, 2020|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
- clinical, biological and radiological characteristics [ Time Frame: through study completion, an average of 1 month ]Describe the clinical, biological and radiological characteristics of COVID-19 patients hospitalized in our center.
- patients' journey description [ Time Frame: through study completion, an average of 1 month ]Describe the patients' journey through our structure.
- Treatments effects [ Time Frame: through study completion, an average of 1 month ]Describe the clinical course of patients treated with the hydroxychloroquine/azithromycin combination in a compassionate context and the side effects observed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364698
|Contact: Aurelien Dinh, MD||+33 1 47 10 77 74||Aurelien.firstname.lastname@example.org|
|Contact: Simon Bessis, MD||+33 1 47 10 77 email@example.com|
|Department of Infectiology, Raymond Poincaré Hospital, APHP||Recruiting|
|Garches, France, 92380|
|Principal Investigator:||Simon Bessis, MD||Infectious diseases department, Raymond Poincaré Hospital, APHP|
|Study Director:||Aurelien Dinh, MD||Infectious diseases department, Raymond Poincaré Hospital, APHP|