NCT04784468

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 3, 2021

Last Update Submit

March 4, 2021

Conditions

Covid19

Keywords

DNA damageOxidative StressInflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The investigators will consider further DNA damage parameter

    Baseline

  • The investigators will consider oxidative stress marker

    Baseline

  • The investigators will consider inflammatory marker

    Baseline

  • The investigators will consider the phenotypic age marker

    Baseline

  • The investigators will consider RDA and DNA gene expression

    Baseline

  • +1 more secondary outcomes

Study Arms (3)

Covid-19

Covid-19 patients

Other: No intervention

Influenza

Influenza patients

Other: No intervention

Cotrol

Control group

Other: No intervention

Interventions

No interventionOTHER

Case-control design, one single investigation

CotrolCovid-19Influenza

Eligibility Criteria

Age40 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • gender: female/male
  • age: ≥40 years
  • patients admitted at the emergency department
  • COVID-19 suspected patients
  • able to give written informed consent

You may not qualify if:

  • children (≤ 18 years) and adults 19-39 years
  • not hospitalized, but confirmed COVID-19 patients (outpatients)
  • patients without definitive COVID-19 confirmation
  • Control group:
  • gender: female/male
  • age: ≥40 years
  • absence of severe illnesses/serious diseases
  • able to give written informed consent
  • 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, …)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Donaustadt

Vienna, 1220, Austria

RECRUITING

MeSH Terms

Conditions

COVID-19Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Karl-Heinz Wagner, PhD

CONTACT

+4314277karl-heinz.wagner@univie.ac.at

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Nutrition

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

November 19, 2020

Primary Completion

March 31, 2021

Study Completion

September 30, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

AU(1)