COVID-19NCT07120269
Predictive Markers of the Course of Covid-19 Based on Biomarker Serum Amyloid A (SAA) and Genetic Markers
A study testing Nasal swab to collect material for RT-PCR SAA evaluation in people with COVID-19, run by Thomayer University Hospital at 1 site in Czechia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Nasal swab to collect material for RT-PCR SAA evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Feb 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Thomayer University Hospital, Department of Respiratory Medicine
Prague
About this study
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.
Read the detailed description
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
- COVID-19
- Being tested
- Nasal swab to collect material for RT-PCR SAA evaluation
- Keywords
- COVID-19, Serum Amyloid A, Predictive markers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swab to collect material for RT-PCR SAA evaluationDiagnostic test
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Individuals without prior SARS-CoV-2 infection and with a negative RT-PCR result Receives: Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation |
| asymptomatic | Experimental | Individuals with an asymptomatic course of SARS-CoV-2 infection Receives: Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation |
| mild and moderate | Experimental | Individuals with a moderate course of SARS-CoV-2 infection (without hospitalization) Receives: Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation |
| Severe | Experimental | Individuals with a severe course of SARS-CoV-2 infection (requiring hospitalization) Receives: Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation |
| Severe ICU | Experimental | Individuals with a severe course of SARS-CoV-2 infection (requiring hospitalization in intensive care units) Receives: Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation |
| Severe below 40 | Experimental | Individuals from study arms 4 and 5 aged below 40 years. Receives: Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of SAA expression to predict clinical picture and outcome of the disease
Levels of expression of SAA are related to the risk of hospitalization for COVID-19
Measured: 14 days
The ability of SAA expression to predict risk of death for COVID-19
Levels of expression of SAA are related to the risk of death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start10 Feb 2021
- Primary completion26 Jun 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomayer University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Principal investigator, Martina Koziar Vašáková, Thomayer University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120269
- Sponsor's protocol ID
- 2511/21 + 4687/21
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Markers of the Course of Covid-19 Based on Biomarker Serum Amyloid A (SAA) and Genetic Markers
- ClinicalTrials.gov ID
- NCT07120269
- Acronym / sponsor ID
- 2511/21 + 4687/21
- Conditions
- COVID-19
- Keywords
- COVID-19, Serum Amyloid A, Predictive markers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Thomayer University HospitalUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluationIndividuals without prior SARS-CoV-2 infection and with a negative RT-PCR result |
| asymptomatic | Experimental | Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluationIndividuals with an asymptomatic course of SARS-CoV-2 infection |
| mild and moderate | Experimental | Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluationIndividuals with a moderate course of SARS-CoV-2 infection (without hospitalization) |
| Severe | Experimental | Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluationIndividuals with a severe course of SARS-CoV-2 infection (requiring hospitalization) |
| Severe ICU | Experimental | Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluationIndividuals with a severe course of SARS-CoV-2 infection (requiring hospitalization in intensive care units) |
| Severe below 40 | Experimental | Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluationIndividuals from study arms 4 and 5 aged below 40 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swab to collect material for RT-PCR SAA evaluationNasal swab for parallel identification of SARS-Cov2 and SAA expression | Diagnostic test | Control Group, Severe, Severe ICU, Severe below 40, asymptomatic, mild and moderate |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swab to collect material for RT-PCR SAA evaluation in people with COVID-19, run by Thomayer University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of SAA expression to predict clinical picture and outcome of the disease (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.