NCT04858581

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 16, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 15, 2021

Last Update Submit

September 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2

OTHER

Survey, RT-PCR test and blood test.

Diagnostic Test: Virological and serological tests

Interventions

Survey, RT-PCR test and blood test

Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Protected healthcare workers
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital privé d'Antony

Paris, 92160, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Jean-Charles Gagnard

    Hôpital privé d'Antony

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Charles GAGNARD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 26, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

September 16, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations