DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients

• Conditions: Covid19
• Interventions: Other: No intervention

• Registration Number: NCT04784468
• Lead Sponsor: University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-19
• Status Verified: 2021-03
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-05
• Last Update Posted: 2021-03-09
• Primary Completion: 2021-03-31
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid-19	No intervention	Covid-19 patients
Influenza	No intervention	Influenza patients
Cotrol	No intervention	Control group

Primary Outcome Measures

Name	Time	Method
DNA damage	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.

Secondary Outcome Measures

Name	Time	Method
The investigators will consider RDA and DNA gene expression	Baseline	Compare RNA and DNA gene expression between hospitalized COVID-19 patients to influenza patients and healthy controls.
The investigators will consider oxidative stress marker	Baseline	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.
The investigators will consider inflammatory marker	Baseline	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.
The investigators will consider clinical biochemistry marker	Baseline	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.
The investigators will consider further DNA damage parameter	Baseline	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.
The investigators will consider the phenotypic age marker	Baseline	Compare the phenotypic age marker between hospitalized COVID-19 patients to influenza patients and healthy controls.

Trial Locations

Locations (1)

Klinik Donaustadt; 🇦🇹 Vienna, Austria