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

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ClinicalTrials.gov Identifier: NCT04364698
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease
COVID-19

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. patients' journey description [ Time Frame: through study completion, an average of 1 month ]
    Describe the patients' journey through our structure.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Aurelien Dinh, MD +33 1 47 10 77 74 Aurelien.dinh@aphp.fr
Contact: Simon Bessis, MD +33 1 47 10 77 74 simon.bessis@aphp.fr

Locations
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France
Department of Infectiology, Raymond Poincaré Hospital, APHP Recruiting
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Simon Bessis, MD Infectious diseases department, Raymond Poincaré Hospital, APHP
Study Director: Aurelien Dinh, MD Infectious diseases department, Raymond Poincaré Hospital, APHP
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04364698    
Other Study ID Numbers: 20SBS-COVID-RPC
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19