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

NCT04887623 | Recruiting

• 1 other identifier: UHHK042021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Respiratory Infection

Keywords

Covid19; Interleukin 6; viremia; nucleocapsid antigen

Outcome Measures

Primary Outcomes (3)

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

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

  Admission

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

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

  Admission

• Prediction of severity of lung dysfunction based on

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

  Admission

Secondary Outcomes (7)

• Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels

  up to 28 days

• Effect of the remdesivir on the nucleocapsid antigen serum levels

  up to 28 days

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

  up to 28 days

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

  up to 28 days

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

  up to 28 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized COVID-19 with moderate to severe course of COVID-19 infection.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

MeSH Terms

Conditions

COVID-19; Viremia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Palicka, MD, CSc.

  University Hospital Hradec Kralove

  STUDY CHAIR

Central Study Contacts

Pavel Dostál, MD, PhD

CONTACT

+420602455632; pavel.dostal@fnhk.cz

Vladimir Koblizek, MD, Ph.D.

CONTACT

+420723448641; vladimir.koblizek@fnhk.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: May 14, 2021
• Study Start: April 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CZ (1)