Clinical trial NCT04655521: Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2
Official title: The Dynamics of the Immune Response to Infection by SARS Coronavirus 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2
Viral Infection
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: MeMed Diagnostics Ltd.
First posted: 2020-12-07
Enrollment: 173
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects 3 months and older with suspicion of COVID-19 that present to the hospital due to suspected COVID-19. Controls with respiratory tract infection (Non-COVID-19) and healthy controls

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.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* confirmed infection with SARS-CoV-2 (except for the controls)

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Differential expression of biomarkers between COVID-19 and controls
timeFrame: up to 90 days
measure: Differential expression of biomarkers between severe and non-severe COVID-19
timeFrame: up to 90 days
measure: Correlation of biomarkers with disease severity
timeFrame: up to 90 days
Secondary outcomes:
measure: Biomarkers depending on therapy
timeFrame: up to 90 days
measure: Biomarkers depending on bacterial co-infection
timeFrame: up to 90 days
measure: Correlation of biomarkers with viral load
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University
Study officials:
affiliation: Universität des Saarlandes
name: Cihan Papan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Tegethoff SA, Danziger G, Kuhn D, Kimmer C, Adams T, Heintz L, Metz C, Reifenrath K, Angresius R, Mang S, Rixecker T, Becker A, Geisel J, Jentgen C, Seiler F, Reichert MC, Frohlich F, Meyer S, Rissland J, Ewen S, Wagenpfeil G, Last K, Smola S, Bals R, Lammert F, Becker SL, Krawczyk M, Lepper PM, Papan C. TNF-related apoptosis-inducing ligand, interferon gamma-induced protein 10, and C-reactive protein in predicting the progression of SARS-CoV-2 infection: a prospective cohort study. Int J Infect Dis. 2022 Sep;122:178-187. doi: 10.1016/j.ijid.2022.05.051. Epub 2022 May 25.