Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2

COVID-19 Clinical Trial

— DIRECTOR  

Official title:

The Dynamics of the Immune Response to Infection by SARS Coronavirus 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655521
• Other study ID #: 109/20
• Status: Completed
• Start date: December 2, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• signed informed consent

• confirmed infection with SARS-CoV-2 (except for the controls)

Exclusion Criteria:

• n/a

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV-2
• Viral Infection
• Virus Diseases

Locations

Country	Name	City	State
Germany	Saarland University	Homburg

Sponsors (2)

Lead Sponsor	Collaborator
Universität des Saarlandes	MeMed Diagnostics Ltd.

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential expression of biomarkers between COVID-19 and controls	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.	up to 90 days
Primary	Differential expression of biomarkers between severe and non-severe COVID-19	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	up to 90 days
Primary	Correlation of biomarkers with disease severity	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.	up to 90 days
Secondary	Biomarkers depending on therapy	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.	up to 90 days
Secondary	Biomarkers depending on bacterial co-infection	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.	up to 90 days
Secondary	Correlation of biomarkers with viral load	Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.	up to 90 days