Covid19ABCDNCT04784468
DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients
An observational study of Covid19, run by University of Vienna at 1 site in Austria.
Trial summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic challenging health systems worldwide. While there is a clear correlation between oxidative stress markers and the severity of many viral diseases such as hepatitis C, for SARS-CoV… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 135 participants
- Where
- 1 siteAustria
- Study dates
- 19 Nov 2020to 30 Sep 2021
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Covid 19 patients: Cases after hospital admission. Influenza: Cases after confirmed influenza diagnosis Healthy controls: Healthy subjects from the general population
Who may be able to join
- gender: female/male
- age: ≥40 years
- patients admitted at the emergency department
- COVID-19 suspected patients
- able to give written informed consent
- gender: female/male
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- age: ≥40 years
- absence of severe illnesses/serious diseases
- able to give written informed consent
- gender: female/male
- age: ≥40 years
- patients admitted at the emergency department
- influenza suspected patients
- able to give written informed consent
Who cannot join
- children (≤ 18 years) and adults 19-39 years
- not hospitalized, but confirmed COVID-19 patients (outpatients)
- patients without definitive COVID-19 confirmation
- Control group:
- children (≤ 18 years) and adults 19-39years
- any current or past clinically significant pathology/disease (comorbidity) such as:
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- Malignancies
- Cardiovascular diseases
- Diabetes mellitus (I and II)
- Obesity class III (BMI >40)
- Other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, …)
- Influenza group:
- children (≤ 18 years) and adults 19-39 years
- patients without definitive influenza confirmation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Klinik Donaustadt
Vienna, 1220
Rainer Thell, MD, +43 67683112550, rainer.thell@wienkav.at
About this study
Official title: DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients Compared to Healthy Controls: A Case-control Study
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic challenging health systems worldwide.
While there is a clear correlation between oxidative stress markers and the severity of many viral diseases such as hepatitis C, for SARS-CoV clinical data is limited.
The investigators aim at 1.) investigating DNA damage, oxidative stress, inflammation, and aging markers in COVID-19 patients and compare them with age and gender matched healthy controls and patients with influenza; and 2.) investigating all aforementioned parameters during "cytokine storm" via repeated blood sampling.
- Conditions
- Covid19
- Being tested
- No intervention
- Keywords
- DNA damage, Oxidative Stress, 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.
No interventionOther
Case-control design, one single investigation
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 | Covid-19 patients Receives: Other: No intervention | |
| Influenza | Influenza patients Receives: Other: No intervention | |
| Cotrol | Control group Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA damage
Compare DNA damage (% of DNA in the tail; measured by the comet assay) between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
Secondary outcomes (6)
The investigators will consider further DNA damage parameter
Compare other DNA damage endpoints measured with the comet assay (i.e. tail length, tail moment and damage index) between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
The investigators will consider oxidative stress marker
Compare oxidative stress biomarker malondialdehyde, FRAP, GSH, GSSG (all µmol/L) and the ration GSH/GSSG between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
The investigators will consider inflammatory marker
Compare inflammatory marker Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha (all rfU) and CRP (mg/dl) between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
The investigators will consider the phenotypic age marker
Compare the phenotypic age marker between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
The investigators will consider RDA and DNA gene expression
Compare RNA and DNA gene expression between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
The investigators will consider clinical biochemistry marker
Compare clinical biochemistry (Total cholesterol (mg/dl), LDL-cholesterol (mg/dl), triglycerides (mg/dl), blood glucose (mg/dl), uric acid (mg/dl)) between hospitalized COVID-19 patients to influenza patients and healthy controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start19 Nov 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- SMZ-Ost Donauspital
- Responsible party
- Principal investigator, Wagner Karl-Heinz, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784468
- Sponsor's protocol ID
- UNIVIE_Covid_Oxstress
- Acronym
- ABCD
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients Compared to Healthy Controls: A Case-control Study
- ClinicalTrials.gov ID
- NCT04784468
- Acronym / sponsor ID
- ABCD / UNIVIE_Covid_Oxstress
- Conditions
- Covid19
- Keywords
- DNA damage, Oxidative Stress, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- SMZ-Ost Donauspital
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 5 Mar 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.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic challenging health systems worldwide.
While there is a clear correlation between oxidative stress markers and the severity of many viral diseases such as hepatitis C, for SARS-CoV clinical data is limited.
The investigators aim at 1.) investigating DNA damage, oxidative stress, inflammation, and aging markers in COVID-19 patients and compare them with age and gender matched healthy controls and patients with influenza; and 2.) investigating all aforementioned parameters during "cytokine storm" via repeated blood sampling.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Covid-19 | – | Other: No interventionCovid-19 patients |
| Influenza | – | Other: No interventionInfluenza patients |
| Cotrol | – | Other: No interventionControl group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Covid 19 patients: Cases after hospital admission. Influenza: Cases after confirmed influenza diagnosis Healthy controls: Healthy subjects from the general population
Key inclusion criteria (14 listed)
- gender: female/male
- age: ≥40 years
- patients admitted at the emergency department
- COVID-19 suspected patients
- able to give written informed consent
Key exclusion criteria (14 listed)
- children (≤ 18 years) and adults 19-39 years
- not hospitalized, but confirmed COVID-19 patients (outpatients)
- patients without definitive COVID-19 confirmation
- children (≤ 18 years) and adults 19-39years
- any current or past clinically significant pathology/disease (comorbidity) such as:
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 |
|---|---|---|
| No interventionCase-control design, one single investigation | Other | Cotrol, Covid-19, Influenza |
Primary outcome
DNA damage
Time frame: Baseline
Compare DNA damage (% of DNA in the tail; measured by the comet assay) between hospitalized COVID-19 patients to influenza patients and healthy controls.
6 secondary outcomes
The investigators will consider further DNA damage parameter
Time frame: Baseline
The investigators will consider oxidative stress marker
Time frame: Baseline
The investigators will consider inflammatory marker
Time frame: Baseline
The investigators will consider the phenotypic age marker
Time frame: Baseline
The investigators will consider RDA and DNA gene expression
Time frame: Baseline
The investigators will consider clinical biochemistry marker
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Covid19, run by University of Vienna at 1 site in Austria.
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 14 inclusion and 14 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 9 Mar 2021. 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 Austria. 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 Karl-Heinz Wagner, PhD (+4314277 ext. 54930, karl-heinz.wagner@univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA damage (time frame: Baseline). 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 9 Mar 2021.