Predictive Markers of the Course of Covid-19 Based on Biomarker Serum Amyloid A (SAA) and Genetic Markers
NCT ID: NCT07120269
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
500 participants
INTERVENTIONAL
2021-02-10
2026-12-31
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Control Group
Individuals without prior SARS-CoV-2 infection and with a negative RT-PCR result
Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
asymptomatic
Individuals with an asymptomatic course of SARS-CoV-2 infection
Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
mild and moderate
Individuals with a moderate course of SARS-CoV-2 infection (without hospitalization)
Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
Severe
Individuals with a severe course of SARS-CoV-2 infection (requiring hospitalization)
Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
Severe ICU
Individuals with a severe course of SARS-CoV-2 infection (requiring hospitalization in intensive care units)
Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
Severe below 40
Individuals from study arms 4 and 5 aged below 40 years.
Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
Interventions
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Nasal swab to collect material for RT-PCR SAA evaluation
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Thomayer University Hospital
OTHER
Responsible Party
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Martina Koziar Vašáková
Head of the Department of Respiratory Medicine
Locations
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Thomayer University Hospital, Department of Respiratory Medicine
Prague, , Czechia
Countries
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Other Identifiers
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2511/21 + 4687/21
Identifier Type: -
Identifier Source: org_study_id
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