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

Sponsor

University Hospital Hradec Kralove (Other)

Overall Status

Recruiting

CT.gov ID

NCT04887623

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Outcome Measures

Primary Outcome Measures

Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels [Admission]
Correlation between baseline nucleocapsid serum levels and the Ordinal Scale for Clinical Improvement
Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels [Admission]
Correlation between baseline interleukin -6 serum levels and Ordinal Scale for Clinical Improvement
Prediction of severity of lung dysfunction based on [Admission]
Correlation between baseline CRP serum levels and Ordinal Scale for Clinical Improvement

Secondary Outcome Measures

Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels [up to 28 days]
Correlation between the dose of corticosteroids and evolution of nucleocapsid serum levels
Effect of the remdesivir on the nucleocapsid antigen serum levels [up to 28 days]
Comparison of the nucleocapsid antigen serum levels between patients receiving and not receiving remdesivir
Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR [up to 28 days]
Analysis of the effect of comorbidities on evolution of viral load assessed using tracheal aspirate semiquantitative PCR
Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR [up to 28 days]
Analysis of the effect of age on evolution of viral load assessed using tracheal aspirate semiquantitative PCR
Effect of age on viral load assesed using nucleocapsid antigen serum levels [up to 28 days]
Analysis of the effect of age on evolution of nucleocapsid antigen serum levels
Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels [up to 28 days]
Analysis of the effect of comorbidites on evolution of nucleocapsid antigen serum levels
Tracheal viral load quantification using tracheal nucleocapsid antigen [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)