Dynamics of Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COVID-19 Respiratory Infection. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Detailed description
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).
Primary outcome measures
- Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels [Time frame: Admission]
- Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels [Time frame: Admission]
- Prediction of severity of lung dysfunction based on [Time frame: Admission]
Secondary outcome measures (7)
- Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels [Time frame: up to 28 days]
- Effect of the remdesivir on the nucleocapsid antigen serum levels [Time frame: up to 28 days]
- Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR [Time frame: up to 28 days]
- Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR [Time frame: up to 28 days]
- Effect of age on viral load assesed using nucleocapsid antigen serum levels [Time frame: up to 28 days]
- Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels [Time frame: up to 28 days]
- Tracheal viral load quantification using tracheal nucleocapsid antigen [Time frame: up to 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Czechia · 1 center
- University Hospital Hradec Kralove — Hradec Králové
Identifiers
NCT: NCT04887623 · UHHK042021