Predictive Markers of the Course of Covid-19 Based on Biomarker Serum Amyloid A (SAA) and Genetic Markers
1 other identifier
interventional
500
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Feb 2021
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedFirst Submitted
Initial submission to the registry
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedAugust 17, 2025
August 1, 2025
2.4 years
August 1, 2025
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
3 months
Study Arms (6)
Control Group
EXPERIMENTALIndividuals without prior SARS-CoV-2 infection and with a negative RT-PCR result
asymptomatic
EXPERIMENTALIndividuals with an asymptomatic course of SARS-CoV-2 infection
mild and moderate
EXPERIMENTALIndividuals with a moderate course of SARS-CoV-2 infection (without hospitalization)
Severe
EXPERIMENTALIndividuals with a severe course of SARS-CoV-2 infection (requiring hospitalization)
Severe ICU
EXPERIMENTALIndividuals with a severe course of SARS-CoV-2 infection (requiring hospitalization in intensive care units)
Severe below 40
EXPERIMENTALIndividuals from study arms 4 and 5 aged below 40 years.
Interventions
Nasal swab for parallel identification of SARS-Cov2 and SAA expression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomayer University Hospitallead
- Charles University, Czech Republiccollaborator
Study Sites (1)
Thomayer University Hospital, Department of Respiratory Medicine
Prague, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department of Respiratory Medicine
Study Record Dates
First Submitted
August 1, 2025
First Posted
August 13, 2025
Study Start
February 10, 2021
Primary Completion
June 26, 2023
Study Completion (Estimated)
December 1, 2026
Last Updated
August 17, 2025
Record last verified: 2025-08