Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04887623

Dynamics of Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients

Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load.

Several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load.

In this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with COVID-19.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location status: Recruiting

Location contact

Pavel Dostal, MD, PhD

CONTACT

[email protected]

00420495832266

About this study

In this pilot study, 30 consecutive COVID-19 patients requiring admission to the hospital due to a moderate and severe COVID-19 infection will be included into an observational study.

Following parameters will be recorded: age, sex, weight, height, comorbidities, smoking habit,spiritus and drug intake history, length of COVID-19 symptoms, clinical and laboratory parameters, the use of different COVID-19 intervention (remdesivir, convalescent plasma, monoclonal antibodies, corticosteroids, tocilizumab and other medication), used initial and maximal organ support during the stay and outcome of the stay in the hospital and 28th and 90th day, laboratory markers of severity of infection - serum and tracheal aspirate (in ventilated patients) levels of nucleocapsid antigen,Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) viremia and quantity in tracheal aspirates (in ventilated patients), makers of inflammatory response (C- reactive proteins, Interleukin 6, procalcitonin, ferritin) and selected other biochemical values (blood count, D-dimers, flow cytometry).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • SARS CoV2 positive test within last 14 day
  • bilateral infiltrates on chest X.ray or CT
  • need for oxygen to keep pulse oximetry saturation above 92% or other respiratory support measures (HFNO, non-invasive ventilation or invasive ventilation)

Exclusion criteria

  • known history of intersticial lung disease
  • known history of congestive heart failure

Treatment and study plan

Primary outcomes

  1. Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels

    Time frame: Admission

    Correlation between baseline nucleocapsid serum levels and the Ordinal Scale for Clinical Improvement

  2. Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels

    Time frame: Admission

    Correlation between baseline interleukin -6 serum levels and Ordinal Scale for Clinical Improvement

  3. Prediction of severity of lung dysfunction based on

    Time frame: Admission

    Correlation between baseline CRP serum levels and Ordinal Scale for Clinical Improvement

Secondary outcomes

  1. Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels

    Time frame: up to 28 days

    Correlation between the dose of corticosteroids and evolution of nucleocapsid serum levels

  2. Effect of the remdesivir on the nucleocapsid antigen serum levels

    Time frame: up to 28 days

    Comparison of the nucleocapsid antigen serum levels between patients receiving and not receiving remdesivir

  3. Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR

    Time frame: up to 28 days

    Analysis of the effect of comorbidities on evolution of viral load assessed using tracheal aspirate semiquantitative PCR

  4. Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR

    Time frame: up to 28 days

    Analysis of the effect of age on evolution of viral load assessed using tracheal aspirate semiquantitative PCR

  5. Effect of age on viral load assesed using nucleocapsid antigen serum levels

    Time frame: up to 28 days

    Analysis of the effect of age on evolution of nucleocapsid antigen serum levels

  6. Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels

    Time frame: up to 28 days

    Analysis of the effect of comorbidites on evolution of nucleocapsid antigen serum levels

  7. Tracheal viral load quantification using tracheal nucleocapsid antigen

    Time frame: up to 28 days

    Correlation between the number of cycles of amplification of real time PCR and nucleocapsid antigen tracheal aspirate levels and between the number of cycles of amplification of real time PCR and nucleocapsid antigen serum levels

Study contacts

Contact information is provided by the study sponsor or research team.

Pavel Dostál, MD, PhD

CONTACT

[email protected]

+420602455632

Vladimir Koblizek, MD, Ph.D.

CONTACT

[email protected]

+420723448641

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

Dynamics of Nucleocapsid Antigen Serum Levels and Other Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients - a Pilot Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 14, 2021
Registry last updated
May 10, 2024

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.

Published trials that share one or more normalized conditions with this study.