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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04655521

Acronym

DIRECTOR

Enrollment

173

Registered

2020-12-07

Start date

2020-12-02

Completion date

2021-09-30

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2, Viral Infection

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Months to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* n/a

Design outcomes

Primary

Measure	Time frame	Description
Differential expression of biomarkers between COVID-19 and controls	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.
Differential expression of biomarkers between severe and non-severe COVID-19	up to 90 days	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
Correlation of biomarkers with disease severity	up to 90 days	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.

Secondary

Measure	Time frame	Description
Biomarkers depending on therapy	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.
Biomarkers depending on bacterial co-infection	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.
Correlation of biomarkers with viral load	up to 90 days	Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.

Countries

Germany

Outcome results