Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19. (Pro-Co-HPA)
Primary Purpose
Covid19
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virological and serological tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility 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
Sites / Locations
- Hopital privé d'Antony
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
Arm Description
Survey, RT-PCR test and blood test.
Outcomes
Primary Outcome Measures
Description of symptoms attributed to COVID-19 at 6 months.
The primary outcome is the description of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test.
Secondary Outcome Measures
Full Information
NCT ID
NCT04858581
First Posted
April 15, 2021
Last Updated
September 15, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT04858581
Brief Title
Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
Acronym
Pro-Co-HPA
Official Title
Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
Arm Type
Other
Arm Description
Survey, RT-PCR test and blood test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Virological and serological tests
Intervention Description
Survey, RT-PCR test and blood test
Primary Outcome Measure Information:
Title
Description of symptoms attributed to COVID-19 at 6 months.
Description
The primary outcome is the description of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test.
Time Frame
6 months after COVID-19 infection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Charles GAGNARD
Phone
0146744380
Email
jeancharles.gagnard@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Gagnard
Organizational Affiliation
Hôpital privé d'Antony
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital privé d'Antony
City
Paris
ZIP/Postal Code
92160
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Gagnard
Phone
0146744380
Email
jeancharles.gagnard@gmail.com
First Name & Middle Initial & Last Name & Degree
Jean-Charles Gagnard
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
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