University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
Location status: Recruiting
NCT Number: NCT04887623
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Hradec Králové, 50005, Czechia
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Admission
Correlation between baseline nucleocapsid serum levels and the Ordinal Scale for Clinical Improvement
Time frame: Admission
Correlation between baseline interleukin -6 serum levels and Ordinal Scale for Clinical Improvement
Time frame: Admission
Correlation between baseline CRP serum levels and Ordinal Scale for Clinical Improvement
Time frame: up to 28 days
Correlation between the dose of corticosteroids and evolution of nucleocapsid serum levels
Time frame: up to 28 days
Comparison of the nucleocapsid antigen serum levels between patients receiving and not receiving remdesivir
Time frame: up to 28 days
Analysis of the effect of comorbidities on evolution of 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
Time frame: up to 28 days
Analysis of the effect of age on evolution of nucleocapsid antigen serum levels
Time frame: up to 28 days
Analysis of the effect of comorbidites on evolution of nucleocapsid antigen serum levels
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
Contact information is provided by the study sponsor or research team.
Pavel Dostál, MD, PhD
CONTACT
Vladimir Koblizek, MD, Ph.D.
CONTACT
University Hospital Hradec Kralove
Other
Dynamics of Nucleocapsid Antigen Serum Levels and Other Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients - a Pilot Study
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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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