COVID-19NCT05145751
SARS CoV-2 Infection and Inflammatory Biomarkers
An observational study of COVID-19 and Inflammation, run by University of Thessaly at 1 site in Greece.
Trial summary
Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Inflammation
- What is being tested?
- Simple inflammatory biomarkers measurement
- How many people
- 115 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2021to 31 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with SARS CoV-2 infection who were treated by the Department of Respiratory Medicine in the UHL will be done. The subjects will be followed from admission to the hospital and up until discharge, transfer to the ICU or death
Who may be able to join
- Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection
Who cannot join
- Patients aged<18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS CoV-2 Infection and Simple Inflammatory Biomarkers.
Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.
Read the detailed description
Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of SARS CoV-2 patients. The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations.
This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.
- Conditions
- COVID-19, Inflammation
- Being tested
- Simple inflammatory biomarkers measurement
- Keywords
- COVID-19, Biomarkers, Inflammation
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple inflammatory biomarkers measurementOther
Also called Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection
In patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection the values of simple inflammatory biomarkers such NLR will be measured
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection | Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection Receives: Other: Simple inflammatory biomarkers measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome
Outcome after COVID-19 infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Apr 2021
- Primary completion1 Oct 2021
- Study completion31 Jan 2022
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.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, M.D., Ph.D., Study chair, Study Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145751
- Sponsor's protocol ID
- 46937
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2021
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS CoV-2 Infection and Simple Inflammatory Biomarkers.
- ClinicalTrials.gov ID
- NCT05145751
- Acronym / sponsor ID
- 46937
- Conditions
- COVID-19, Inflammation
- Keywords
- COVID-19, Biomarkers, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Dec 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.
Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.
Detailed description
Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of SARS CoV-2 patients. The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations.
This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection | – | Other: Simple inflammatory biomarkers measurementConsecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with SARS CoV-2 infection who were treated by the Department of Respiratory Medicine in the UHL will be done. The subjects will be followed from admission to the hospital and up until discharge, transfer to the ICU or death
Key inclusion criteria (1 listed)
- Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection
Key exclusion criteria (1 listed)
- Patients aged<18 years
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 |
|---|---|---|
| Simple inflammatory biomarkers measurementAlso: Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infectionIn patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection the values of simple inflammatory biomarkers such NLR will be measured | Other | COVID-19 infection |
Primary outcome
Outcome
Time frame: 1 year
Outcome after COVID-19 infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Eleni Arnaoutoglou, M.D., Ph.D. study chair
Study Chair
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 and Inflammation, run by University of Thessaly at 1 site in Greece.
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: finished, as of the sponsor's last update on 2 Mar 2022. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Outcome (time frame: 1 year). 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 2 Mar 2022.