Clinical trial NCT04887623: Dynamics of Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Respiratory Infection
Keywords: Covid19
Interleukin 6
viremia
nucleocapsid antigen
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized COVID-19 with moderate to severe course of COVID-19 infection.

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.

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).

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

Primary outcomes:
measure: Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels
timeFrame: Admission
measure: Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels
timeFrame: Admission
measure: Prediction of severity of lung dysfunction based on
timeFrame: Admission
Secondary outcomes:
measure: Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels
timeFrame: up to 28 days
measure: Effect of the remdesivir on the nucleocapsid antigen serum levels
timeFrame: up to 28 days
measure: Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR
timeFrame: up to 28 days
measure: Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR
timeFrame: up to 28 days
measure: Effect of age on viral load assesed using nucleocapsid antigen serum levels
timeFrame: up to 28 days
measure: Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels
timeFrame: up to 28 days
measure: Tracheal viral load quantification using tracheal nucleocapsid antigen
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vladimir Palicka, MD, CSc.
role: STUDY_CHAIR
References: