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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04858581
Collaborator
(none)
100
1
1
24
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Virological and serological tests
N/A

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

Study Type:
Interventional
Anticipated 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.
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Description of symptoms attributed to COVID-19 at 6 months. [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hopital privé d'Antony Paris France 92160

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Jean-Charles Gagnard, Hôpital privé d'Antony

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT04858581
Other Study ID Numbers:
  • 2020-A02720-39
First Posted:
Apr 26, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021