coronavirus infection COVID-19 infection
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective To determine the diagnostic accuracy of TRAIL and/or IP-10 for detection of viral infections including COVID-19 during the pre-symptomatic phase in healthcare workers at increased risk for respiratory viral infection. Primary Endpoint Sensitivity of TRAIL and/or IP-10 measured in pre-symptomatic healthcare workers (Index test) for PCR confirmed viral infections including COVID-19. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives 1. To determine the diagnostic accuracy of TRAIL and/or IP-10 for detection of viral infections including COVID-19 during the early symptomatic phase in healthcare workers at increased risk for respiratory viral infection 2. To determine if TRAIL and/or IP-10 are related to severity of COVID-19 disease in healthcare workers after developing COVID-19 3. To identify additional candidate biomarkers to detect early viral infection and/or disease severity in healthcare workers after developing COVID-19 4. To determine asymptomatic COVID-19 infections in healthcare workers Secondary Endpoints 1. Sensitivity and specificity of TRAIL and/or IP-10 in early symptomatic healthcare workersSensitivity and specificity of TRAIL and/or IP-10 in all healthcare workers measured at maximum 48 hours before onset of symptoms 2. Sensitivity and specificity of TRAIL and/or IP-10 in all healthcare workers measured every 24 hours 3. Sensitivity and specificity of TRAIL and/or IP-10 in pre-symptomatic healthcare workers for PCR confirmed COVID-19 infection 4. Sensitivity and specificity of TRAIL and/or IP-10 in COVID-19 infected healthcare workers related to disease severity mesasured on day 1, 2 and 3 after onset of symptoms 5. The proportion of healthcare workers with COVID-19 who are asymptomatic | — |
Countries
Netherlands
Outcome results
None listed