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Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19. (Pro-Co-HPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04858581
Recruitment Status : Not yet recruiting
First Posted : April 26, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
GCS Ramsay Santé pour l'Enseignement et la Recherche

Study Description
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Brief Summary:

Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019.

In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. In addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%).

An increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the COVID-19.

Mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of SARS-CoV-2 infection were identified. But, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. In this context of an emerging viral infection such as SARS-CoV-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.


Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: Virological and serological tests Not Applicable

Detailed Description:

The scientific and medical world is mobilizing to accelerate the production of knowledge on this virus, on the disease it causes as well as the means of curing and preventing it. But no one yet knows how much it can cause immunological changes in the body. For some specialists, this virus is even much more than a viral infection and causes a general disruption of the immune system.

Faced with the COVID-19 pandemic, healthcare workers are a particularly exposed.

The main objective of this research is to assess the presence of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test of healthcare workers.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
Survey, RT-PCR test and blood test.
 Diagnostic Test: Virological and serological tests
Survey, RT-PCR test and blood test


Outcome Measures
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Primary Outcome Measures :
  1. Description of symptoms attributed to COVID-19 at 6 months. [ Time Frame: 6 months after COVID-19 infection ]
    The primary outcome is the description of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthcare workers over 18 years of age
  • Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
  • Healthcare workers with signed consent

Exclusion Criteria:

  • Protected healthcare workers
  • Pregnant or breastfeeding woman
Contacts and Locations
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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): NCT04858581


Contacts
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Contact: Jean-Charles GAGNARD 0146744380 jeancharles.gagnard@gmail.com

Locations
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France
Hopital privé d'Antony
Paris, France, 92160
Contact: Jean-Charles Gagnard    0146744380    jeancharles.gagnard@gmail.com   
Principal Investigator: Jean-Charles Gagnard         
Sponsors and Collaborators
GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
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Principal Investigator: Jean-Charles Gagnard Hôpital privé d'Antony
More Information
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Responsible Party: GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier: NCT04858581    
Other Study ID Numbers: 2020-A02720-39
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: April 2021
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases