DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients (ABCD)

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 135

Contacts and Locations

• Study Contact: Name: Karl-Heinz Wagner, PhD; Phone Number: 54930 +4314277; Email: karl-heinz.wagner@univie.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1220
    • Recruiting
    • Klinik Donaustadt
    • Contact: Rainer Thell, MD; Phone Number: +43 67683112550; Email: rainer.thell@wienkav.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Covid 19 patients:

Cases after hospital admission.

Influenza:

Cases after confirmed influenza diagnosis

Healthy controls:

Healthy subjects from the general population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid-19; Covid-19 patients	Other: No intervention; Case-control design, one single investigation
Influenza; Influenza patients	Other: No intervention; Case-control design, one single investigation
Cotrol; Control group	Other: No intervention; Case-control design, one single investigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Vienna
• Collaborators: SMZ-Ost Donauspital

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Oxidative Stress; DNA damage
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UNIVIE_Covid_Oxstress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No