Clinical trial NCT04364698: Observational Cohort of COVID-19 Patients at Raymond-Poincare
Official title: Observational Cohort of COVID-19 Patients at Raymond-Poincare
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient ≥ 18 years old SARS-CoV-2 infection confirmed by PCR or strongly suspected on compatible radio-clinical grounds during an epidemic period.

Brief summary: 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.

Detailed description: 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.

Study scheme:

Longitudinal cohort study of patients with confirmed or strongly suspected CoV-2 SARS infection.

Eligibility criteria: Inclusion criteria:

* Patient ≥ 18 years old
* SARS-CoV-2 infection confirmed by PCR or strongly suspected on compatible radio-clinical grounds during an epidemic period.

Exclusion criteria:

* Not able to express their opposition
* Patient under guardianship or curatorship

Primary outcomes:
measure: clinical, biological and radiological characteristics
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: patients' journey description
timeFrame: through study completion, an average of 1 month
measure: Treatments effects
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Garches
country: France
facility: Department of Infectiology, Raymond Poincaré Hospital, APHP
Study officials:
affiliation: Infectious diseases department, Raymond Poincaré Hospital, APHP
name: Simon Bessis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious diseases department, Raymond Poincaré Hospital, APHP
name: Aurelien Dinh, MD
role: STUDY_DIRECTOR
References:
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