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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity Hospital Hradec Kralove

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

known history of intersticial lung disease

known history of congestive heart failure

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Admission
2

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

Time frame
Admission
3

Prediction of severity of lung dysfunction based on

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

Time frame
Admission

Secondary outcomes

1

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

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

Time frame
up to 28 days
2

Effect of the remdesivir on the nucleocapsid antigen serum levels

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

Time frame
up to 28 days
3

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

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

Time frame
up to 28 days
4

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

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

Time frame
up to 28 days

Other outcomes

Sponsors and contacts

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