Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.

Covid19 Clinical Trial

— Pro-Co-HPA  

Official title:

Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04858581
• Other study ID #: 2020-A02720-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Jean-Charles GAGNARD
• Phone: 0146744380
• Email: jeancharles.gagnard[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Virological and serological tests
Survey, RT-PCR test and blood test

Locations

Country	Name	City	State
France	Hopital privé d'Antony	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after COVID-19 infection