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CompletedNCT04655521DIRECTORUpdated Nov 24, 2021

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

An observational study in COVID-19, SARS-CoV-2 and Viral Infection, sponsored by Universität des Saarlandes. Completed at 1 site in Germany. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-24.

Sponsored by Universität des Saarlandes · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
173
Ages
3 Months and older
Sex
All
01

Study 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.

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Conditions studied

  • COVID-19
  • SARS-CoV-2
  • Viral Infection
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 173 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Universität des Saarlandes is the lead sponsor of 64 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • n/a
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
173 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • COVID-19 patients
  • Healthy controls
  • Non-COVID-19 patients with respiratory tract infection
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 90 days

  2. 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

    Time frame: up to 90 days

  3. 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.

    Time frame: up to 90 days

Secondary outcomes

  1. 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.

    Time frame: up to 90 days

  2. 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.

    Time frame: up to 90 days

  3. 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.

    Time frame: up to 90 days

07

Study locations

1 site
  • Saarland University
    Homburg, 66421, Germany
08

References and documents

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. PubMed 25785720 ↗
  • 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. PubMed 28012942 ↗
  • 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. PubMed 35643306 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04655521
Lead sponsor
Universität des Saarlandes
Collaborators
MeMed Diagnostics Ltd.
Responsible party
Cihan Papan (MD, Universität des Saarlandes) — Principal investigator
First posted
Dec 7, 2020
Start date
Dec 2, 2020
Primary completion
Jun 30, 2021
Completion
Sep 30, 2021
Last update
Nov 24, 2021

Study contacts

Cihan Papan, MD
principal investigator · Universität des Saarlandes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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