NCT07120269

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable covid19

Timeline
7mo left

Started Feb 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Feb 2021Dec 2026

Study Start

First participant enrolled

February 10, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

August 1, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

COVID-19Serum Amyloid APredictive markers

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

EXPERIMENTAL

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

Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation

asymptomatic

EXPERIMENTAL

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

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)

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)

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)

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.

Diagnostic Test: Nasal swab to collect material for RT-PCR SAA evaluation

Interventions

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

Control GroupSevereSevere ICUSevere below 40asymptomaticmild and moderate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Thomayer University Hospital, Department of Respiratory Medicine

Prague, Czechia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

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

Locations