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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control Group

Individuals without prior SARS-CoV-2 infection and with a negative RT-PCR result

Group Type EXPERIMENTAL

Nasal swab to collect material for RT-PCR SAA evaluation

Intervention Type DIAGNOSTIC_TEST

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

asymptomatic

Individuals with an asymptomatic course of SARS-CoV-2 infection

Group Type EXPERIMENTAL

Nasal swab to collect material for RT-PCR SAA evaluation

Intervention Type DIAGNOSTIC_TEST

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)

Group Type EXPERIMENTAL

Nasal swab to collect material for RT-PCR SAA evaluation

Intervention Type DIAGNOSTIC_TEST

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

Severe

Individuals with a severe course of SARS-CoV-2 infection (requiring hospitalization)

Group Type EXPERIMENTAL

Nasal swab to collect material for RT-PCR SAA evaluation

Intervention Type DIAGNOSTIC_TEST

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)

Group Type EXPERIMENTAL

Nasal swab to collect material for RT-PCR SAA evaluation

Intervention Type DIAGNOSTIC_TEST

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.

Group Type EXPERIMENTAL

Nasal swab to collect material for RT-PCR SAA evaluation

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Thomayer University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martina Koziar Vašáková

Head of the Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thomayer University Hospital, Department of Respiratory Medicine

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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2511/21 + 4687/21

Identifier Type: -

Identifier Source: org_study_id

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