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

NCT ID: NCT04655521

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-02

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 SARS-CoV-2 Viral Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 patients

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Non-COVID-19 patients with respiratory tract infection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* n/a
Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MeMed Diagnostics Ltd.

INDUSTRY

Sponsor Role collaborator

Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Cihan Papan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cihan Papan, MD

Role: PRINCIPAL_INVESTIGATOR

Universität des Saarlandes

Locations

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Saarland University

Homburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25785720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28012942 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35643306 (View on PubMed)

Other Identifiers

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109/20

Identifier Type: -

Identifier Source: org_study_id