Clinical trial NCT04784468: DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients
Official title: DNA Damage and Oxidative Stress in Hospitalized COVID-19 Patients Compared to Healthy Controls: A Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: DNA damage
Oxidative Stress
Inflammation
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: SMZ-Ost Donauspital
First posted: 2021-03-05
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: DNA damage
timeFrame: Baseline
Secondary outcomes:
measure: The investigators will consider further DNA damage parameter
timeFrame: Baseline
measure: The investigators will consider oxidative stress marker
timeFrame: Baseline
measure: The investigators will consider inflammatory marker
timeFrame: Baseline
measure: The investigators will consider the phenotypic age marker
timeFrame: Baseline
measure: The investigators will consider RDA and DNA gene expression
timeFrame: Baseline
measure: The investigators will consider clinical biochemistry marker
timeFrame: Baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Donaustadt
Study officials:
References: