DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients

Covid19 Clinical Trial

— ABCD  

Official title:

DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients Compared to Healthy Controls: A Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04784468
• Other study ID #: UNIVIE_Covid_Oxstress
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: University of Vienna
• Contact: Karl-Heinz Wagner, PhD
• Phone: +4314277
• Email: karl-heinz.wagner[@]univie.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: September 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Covid 19 group:

Inclusion Criteria:

• gender: female/male

• age: =40 years

• patients admitted at the emergency department

• COVID-19 suspected patients

• able to give written informed consent

Exclusion Criteria:

• children (= 18 years) and adults 19-39 years

• not hospitalized, but confirmed COVID-19 patients (outpatients)

• patients without definitive COVID-19 confirmation

Control group:

Inclusion criteria:

• gender: female/male

• age: =40 years

• absence of severe illnesses/serious diseases

• able to give written informed consent

Exclusion criteria:

• children (= 18 years) and adults 19-39years

• any current or past clinically significant pathology/disease (comorbidity) such as:

• 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:

Inclusion criteria:

• gender: female/male

• age: =40 years

• patients admitted at the emergency department

• influenza suspected patients

• able to give written informed consent

Exclusion criteria:

• children (= 18 years) and adults 19-39 years

• patients without definitive influenza confirmation

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• No intervention
Case-control design, one single investigation

Locations

Country	Name	City	State
Austria	Klinik Donaustadt	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
University of Vienna	SMZ-Ost Donauspital

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	The investigators will consider the phenotypic age marker	Compare the phenotypic age marker between hospitalized COVID-19 patients to influenza patients and healthy controls.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline