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Observational Cohort of COVID-19 Patients at Raymond-Poincare

Observational Cohort of COVID-19 Patients at Raymond-Poincare

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04364698
Acronym
COVID-RPC
Enrollment
500
Registered
2020-04-28
Start date
2020-05-07
Completion date
2020-06-30
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical, biological and radiological characteristicsthrough study completion, an average of 1 monthDescribe the clinical, biological and radiological characteristics of COVID-19 patients hospitalized in our center.

Secondary

MeasureTime frameDescription
patients' journey descriptionthrough study completion, an average of 1 monthDescribe the patients' journey through our structure.
Treatments effectsthrough study completion, an average of 1 monthDescribe the clinical course of patients treated with the hydroxychloroquine/azithromycin combination in a compassionate context and the side effects observed.

Countries

France

Contacts

Primary ContactAurelien Dinh, MD
Aurelien.dinh@aphp.fr+33 1 47 10 77 74
Backup ContactSimon Bessis, MD
simon.bessis@aphp.fr+33 1 47 10 77 74

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026