COVID-19 Respiratory InfectionNCT04887623
Dynamics of Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients
An observational study of COVID-19 Respiratory Infection, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2021to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized COVID-19 with moderate to severe course of COVID-19 infection.
Who may be able to join
- SARS CoV2 positive test within last 14 day
- bilateral infiltrates on chest X.ray or CT
- need for oxygen to keep pulse oximetry saturation above 92% or other respiratory support measures (HFNO, non-invasive ventilation or invasive ventilation)
Who cannot join
- known history of intersticial lung disease
- known history of congestive heart failure
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
Pavel Dostal, MD, PhD, 00420495832266, pavel.dostal@fnhk.cz
About this study
Official title: Dynamics of Nucleocapsid Antigen Serum Levels and Other Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients - a Pilot Study
Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load.
Several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load.
In this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with COVID-19.
Read the detailed description
In this pilot study, 30 consecutive COVID-19 patients requiring admission to the hospital due to a moderate and severe COVID-19 infection will be included into an observational study.
Following parameters will be recorded: age, sex, weight, height, comorbidities, smoking habit,spiritus and drug intake history, length of COVID-19 symptoms, clinical and laboratory parameters, the use of different COVID-19 intervention (remdesivir, convalescent plasma, monoclonal antibodies, corticosteroids, tocilizumab and other medication), used initial and maximal organ support during the stay and outcome of the stay in the hospital and 28th and 90th day, laboratory markers of severity of infection - serum and tracheal aspirate (in ventilated patients) levels of nucleocapsid antigen,Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) viremia and quantity in tracheal aspirates (in ventilated patients), makers of inflammatory response (C- reactive proteins, Interleukin 6, procalcitonin, ferritin) and selected other biochemical values (blood count, D-dimers, flow cytometry).
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Covid19, Interleukin 6, viremia, nucleocapsid antigen
- Medical subject headings
- COVID-19, Viremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels
Correlation between baseline nucleocapsid serum levels and the Ordinal Scale for Clinical Improvement
Measured: Admission
Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels
Correlation between baseline interleukin -6 serum levels and Ordinal Scale for Clinical Improvement
Measured: Admission
Prediction of severity of lung dysfunction based on
Correlation between baseline CRP serum levels and Ordinal Scale for Clinical Improvement
Measured: Admission
Secondary outcomes (7)
Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels
Correlation between the dose of corticosteroids and evolution of nucleocapsid serum levels
Measured: up to 28 days
Effect of the remdesivir on the nucleocapsid antigen serum levels
Comparison of the nucleocapsid antigen serum levels between patients receiving and not receiving remdesivir
Measured: up to 28 days
Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR
Analysis of the effect of comorbidities on evolution of viral load assessed using tracheal aspirate semiquantitative PCR
Measured: up to 28 days
Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR
Analysis of the effect of age on evolution of viral load assessed using tracheal aspirate semiquantitative PCR
Measured: up to 28 days
Effect of age on viral load assesed using nucleocapsid antigen serum levels
Analysis of the effect of age on evolution of nucleocapsid antigen serum levels
Measured: up to 28 days
Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels
Analysis of the effect of comorbidites on evolution of nucleocapsid antigen serum levels
Measured: up to 28 days
Tracheal viral load quantification using tracheal nucleocapsid antigen
Correlation between the number of cycles of amplification of real time PCR and nucleocapsid antigen tracheal aspirate levels and between the number of cycles of amplification of real time PCR and nucleocapsid antigen serum levels
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Apr 2021
- Primary completionJul 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Vladimir Palicka, MD, CSc., Study chair, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887623
- Sponsor's protocol ID
- UHHK042021
- Status last verified
- May 2024
- First submitted
- 27 Mar 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of Nucleocapsid Antigen Serum Levels and Other Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT04887623
- Acronym / sponsor ID
- UHHK042021
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- Covid19, Interleukin 6, viremia, nucleocapsid antigen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 May 2021 (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.
Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load.
Several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load.
In this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with COVID-19.
Detailed description
In this pilot study, 30 consecutive COVID-19 patients requiring admission to the hospital due to a moderate and severe COVID-19 infection will be included into an observational study.
Following parameters will be recorded: age, sex, weight, height, comorbidities, smoking habit,spiritus and drug intake history, length of COVID-19 symptoms, clinical and laboratory parameters, the use of different COVID-19 intervention (remdesivir, convalescent plasma, monoclonal antibodies, corticosteroids, tocilizumab and other medication), used initial and maximal organ support during the stay and outcome of the stay in the hospital and 28th and 90th day, laboratory markers of severity of infection - serum and tracheal aspirate (in ventilated patients) levels of nucleocapsid antigen,Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) viremia and quantity in tracheal aspirates (in ventilated patients), makers of inflammatory response (C- reactive proteins, Interleukin 6, procalcitonin, ferritin) and selected other biochemical values (blood count, D-dimers, flow cytometry).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized COVID-19 with moderate to severe course of COVID-19 infection.
Key inclusion criteria (3 listed)
- SARS CoV2 positive test within last 14 day
- bilateral infiltrates on chest X.ray or CT
- need for oxygen to keep pulse oximetry saturation above 92% or other respiratory support measures (HFNO, non-invasive ventilation or invasive ventilation)
Key exclusion criteria (2 listed)
- known history of intersticial lung disease
- known history of congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels
Time frame: Admission
Correlation between baseline nucleocapsid serum levels and the Ordinal Scale for Clinical Improvement
Prediction of severity of lung dysfunction based on initial interleukin-6 serum levels
Time frame: Admission
Correlation between baseline interleukin -6 serum levels and Ordinal Scale for Clinical Improvement
Prediction of severity of lung dysfunction based on
Time frame: Admission
Correlation between baseline CRP serum levels and Ordinal Scale for Clinical Improvement
7 secondary outcomes
Effect of the dose of corticosteroids on the nucleocapsid antigen serum levels
Time frame: up to 28 days
Effect of the remdesivir on the nucleocapsid antigen serum levels
Time frame: up to 28 days
Effect of comorbidities on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR
Time frame: up to 28 days
Effect of age on persistence of tracheal viral load assessed using tracheal aspirate semiquantitative PCR
Time frame: up to 28 days
Effect of age on viral load assesed using nucleocapsid antigen serum levels
Time frame: up to 28 days
Effect of comorbidities on viral load assessed using nucleocapsid antigen serum levels
Time frame: up to 28 days
Tracheal viral load quantification using tracheal nucleocapsid antigen
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19 Respiratory Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
Vladimir Palicka, MD, CSc. study chair
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection, run by University Hospital Hradec Kralove 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Dostál, MD, PhD (+420602455632, pavel.dostal@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of severity of lung dysfunction based on initial nucleocapsid antigen serum levels (time frame: Admission). The study lists 3 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 10 May 2024.