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Observational Cohort of COVID-19 Patients at Raymond-Poincare (COVID-RPC)

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

COVID-19

Study type

Observational

Funder types

Other

Identifiers

NCT04364698
20SBS-COVID-RPC

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Simon Bessis, MD; Aurelien Dinh, MD

Data sourced from clinicaltrials.gov

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