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NCT Number: NCT07120269

Predictive Markers of the Course of Covid-19 Based on Biomarker Serum Amyloid A (SAA) and Genetic Markers

This study focuses on identifying genetic and biochemical markers (biomarkers) that could help predict the course of COVID-19. The investigators aim to analyze samples taken from the nasopharynx (nose and throat), saliva, and blood of patients with acute respiratory tract infections who come to the Outpatient Clinic of the Department of Respiratory Diseases at the Thomayer University Hospital.

The main objectives include measuring the expression of the SAA1 gene (using quantitative RT-PCR) and conducting broader gene expression analysis (using RNA sequencing) in nasopharyngeal cells. At the same time, the investigators will examine the patients' DNA to identify rare genetic variants or common polymorphisms that may influence their immune response to the virus.

The goal is to relate the values of SAA expression with clinical and radiological status and outcome of the patients. The investigators hypothesize, that SAA may predict the severity of the disease, need for hospitalizastion and outcome of the patients.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomayer University Hospital, Department of Respiratory Medicine

Prague, Czechia

About this study

This cross-sectional study evaluated nasal SAA1 expression as a biomarker for early detection and severity assessment of respiratory tract infections, particularly in COVID-19 patients. A total of 369 participants presenting with infectious or non-infectious respiratory symptoms to the outpatient clinic were prospectively recruited between March 6, 2021, and June 26, 2023.

Each patient underwent a single nasopharyngeal swab, which was used both for RT-qPCR testing of SARS-CoV-2 RNA and for SAA1 expression analysis, ensuring methodological consistency and direct comparability of results. Additionally, all participants underwent a chest X-ray, a comprehensive clinical examination, and routine blood and biochemistry testing.

RNA Extraction and SAA1 mRNA Quantification:

Nasal swabs were collected and stored under RNase-free conditions for RNA extraction. The relative expression of SAA1 was determined using real-time quantitative polymerase chain reaction (RT-qPCR).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients coming to the outpatient clinic and emergency room of the Department of Respiratory Diseases in Thomayer Hospital with symptoms of acute respiratory infection

Exclusion criteria

  • Inability to sign the informed consent

Treatment and study plan

Nasal swab to collect material for RT-PCR SAA evaluation

Diagnostic Test

Nasal swab for parallel identification of SARS-Cov2 and SAA expression

Primary outcomes

  1. The ability of SAA expression to predict clinical picture and outcome of the disease

    Time frame: 14 days

    Levels of expression of SAA are related to the risk of hospitalization for COVID-19

  2. The ability of SAA expression to predict risk of death for COVID-19

    Time frame: 3 months

    Levels of expression of SAA are related to the risk of death

Sponsors and collaborators

Lead sponsor

Thomayer University Hospital

Other

Collaborators

  • Charles University, Czech Republic

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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