DIRECTOR: Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2
Study Details
Study Description
Brief Summary
To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 patients
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| Healthy controls
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| Non-COVID-19 patients with respiratory tract infection
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Outcome Measures
Primary Outcome Measures
- Differential expression of biomarkers between COVID-19 and controls [up to 90 days]
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.
- Differential expression of biomarkers between severe and non-severe COVID-19 [up to 90 days]
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection
- Correlation of biomarkers with disease severity [up to 90 days]
Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality.
Secondary Outcome Measures
- Biomarkers depending on therapy [up to 90 days]
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.
- Biomarkers depending on bacterial co-infection [up to 90 days]
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.
- Correlation of biomarkers with viral load [up to 90 days]
Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.
Eligibility Criteria
Criteria
Inclusion Criteria:
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signed informed consent
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confirmed infection with SARS-CoV-2 (except for the controls)
Exclusion Criteria:
- n/a
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saarland University | Homburg | Germany | 66421 |
Sponsors and Collaborators
- Universität des Saarlandes
- MeMed Diagnostics Ltd.
Investigators
- Principal Investigator: Cihan Papan, MD, Universität des Saarlandes
Study Documents (Full-Text)
None provided.More Information
Publications
- Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
- van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.
- 109/20