Hospital Employees Response Ante COVID-19 Listed Early Symptoms (HERACLES): A clinical study to examine the dynamics of the host-response to viral infection including COVID-19 in healthcare workers

Recruiting

Conditions: coronavirus infection
COVID-19 infection
10047438

Registration Number: NL-OMON49285

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 333

Inclusion Criteria

Adult healthcare workers who have signed informed consent form will be eligible
for inclusion. In order to be eligible to participate in this study, a subject
must meet all of the following criteria:
* No symptoms of acute respiratory tract infection at time of enrollment
* No symptoms of acute respiratory tract infection in the previous two weeks
* Risk of exposure to COVID-19 infected patients defined by daily bedside care
for patients

Exclusion Criteria

A potential subject who meets the following criteria will be excluded from
participation in this study:
* An incute respiratory infection during the previous two weeks
* Previously proven COVID-19 infection
* A proven or suspected HIV, HBV, or HCV infection
* Active malignancy
* Current treatment with immune-suppresives or immune-modulation therapies
* Severe illnesses that affect life expectancy and quality of life (other than
suspected COVID-19 infection)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>To determine the diagnostic accuracy of TRAIL and/or IP-10 for detection of<br /><br>viral infections including COVID-19 during the pre-symptomatic phase in<br /><br>healthcare workers at increased risk for respiratory viral infection.<br /><br><br /><br>Primary Endpoint<br /><br>Sensitivity of TRAIL and/or IP-10 measured in pre-symptomatic healthcare<br /><br>workers (Index test) for PCR confirmed viral infections including COVID-19.<br /><br><br /><br></p><br>

Secondary Outcome Measures