NCT04655521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

December 2, 2020

Last Update Submit

November 23, 2021

Conditions

COVID-19SARS-CoV-2Viral Infection

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Biomarkers depending on therapy

    up to 90 days

  • Biomarkers depending on bacterial co-infection

    up to 90 days

  • Correlation of biomarkers with viral load

    up to 90 days

Study Arms (3)

COVID-19 patients

Healthy controls

Non-COVID-19 patients with respiratory tract infection

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University

Homburg, 66421, Germany

Location

Related Publications (3)

  • 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.

    PMID: 25785720BACKGROUND

  • 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.

    PMID: 28012942BACKGROUND

  • 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.

    PMID: 35643306DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

COVID-19Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Cihan Papan, MD

    Universität des Saarlandes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 7, 2020

Study Start

December 2, 2020

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

DE(1)