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OpenTrials
Completed

NCT Number: NCT04655521

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

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Viral Infection Virus Diseases

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saarland University

Homburg, 66421, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • n/a

Treatment and study plan

Primary outcomes

  1. Differential expression of biomarkers between COVID-19 and controls

    Time frame: 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.

  2. Differential expression of biomarkers between severe and non-severe COVID-19

    Time frame: 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

  3. Correlation of biomarkers with disease severity

    Time frame: 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 outcomes

  1. Biomarkers depending on therapy

    Time frame: 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.

  2. Biomarkers depending on bacterial co-infection

    Time frame: 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.

  3. Correlation of biomarkers with viral load

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Collaborators

  • MeMed Diagnostics Ltd.

Registry information

Official study title

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

Acronym: DIRECTOR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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