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DNA Damage in Critically Ill COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04772703
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Information provided by (Responsible Party):
University Hospital Hradec Kralove

Brief Summary:
Critically ill patients with COVID-19 are exposed to high oxidative stress which is potential harm to the DNA. Peripheral lymphocytes' DNA will be investigated using the comet assay on changes in oxidative damage to the purine and pyrimidine bases and single-stranded DNA breaks.

Condition or disease Intervention/treatment
Covid19 Organ Failure, Multiple DNA Damage Diagnostic Test: COMET ASSAY

Detailed Description:

Data from hospital documentation will be recorded for all patients: demographic data, clinical data (Horowitz index, the necessity of pronation position, opening maneuvers, connection to ECMO, state of the circulation and other organ functions), laboratory data: parameters of inflammatory activity and COVID-19 specific markers (blood count with differential leukocyte count, CRP, IL-6, ferritin, procalcitonin, D-dimers).

In the study, 4 ml of heparinized peripheral blood will be collected for analytical purposes beyond standard practice for lymphocyte isolation and monitoring of oxidative DNA damage upon admission to the ICU (D1), after 2 days (D3) and on day 7 (D7) of the hospitalization. The same blood sample will be used to determine EPA and DHA omega-3 in erythrocyte membranes. At the same intervals and frequency, 10 ml of urine will be collected for the determination of 8-hydroxy-2-deoxyquanosine (8-OHdG), so a total of 30 ml of urine will be collected for analytical purposes.

Details for analytical processing: peripheral blood lymphocyte damage will be assessed using the alkaline COMET ASSAY method for DNA breakage and modified COMET ASSAY using specific enzymes for the detection of oxidized bases, endonuclease III (ENDO III) for the detection of oxidized pyrimidines and formamidopyrimidine DNA glycosylase (FPG) for the detection of oxidized purines. Leukocyte repair capacity will be determined using a modified COMET ASSAY, which uses extracts of patient lymphocytes and HeLa cells with defined DNA damage. The extent of 8-hydroxy-2-deoxyquanosine (8-OHdG) DNA damage in patients' urine will be determined by determining the concentration of 8-OHdG by ELISA.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Damage in Critically Ill Patients With SARS-CoV-2 Infection With Organ Failure
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : July 30, 2021

Intervention Details:
  • Diagnostic Test: COMET ASSAY
    The description in the detailed description of the study

Primary Outcome Measures :
  1. single-stranded DNA breaks [ Time Frame: One week ]
    Changes in the single-stranded DNA breaks in peripheral lymphocytes

  2. oxidation of DNA bases [ Time Frame: One week ]
    Changes in oxidised purine and pyrimidine bases of peripheral lymphocytes DNA

Secondary Outcome Measures :
  1. Mortality [ Time Frame: One month ]
    All cause 30-day mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients admitted to ICU with signs and symptoms of organ failure, mainly respiratory failure. Need for means of respiratory and/or circulatory support. A positive test of COVID-19: RT-PCR test or bed-side antigen test.

Inclusion Criteria:

  • critically ill adult patient admitted to ICU with positive RT-PCR test or bed-side antigen test on COVID-19 with signs and symptoms of organ failure
  • informed consent

Exclusion Criteria:

  • rejection by the patient to sign an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04772703

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Contact: Zdeněk Zadák, prof., M.D., Ph.D. +420495832166
Contact: David Astapenko, M.D., Ph.D. +420495833218

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University Hospital Hradec Kralove Recruiting
Hradec Králové, Třebeš, Czechia, 50005
Contact: Pavel Dostal, M.D., Ph.D., MBA    +420495833218   
Contact: David Astapenko, M.D., Ph.D.    +420495833218   
Sponsors and Collaborators
University Hospital Hradec Kralove
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Responsible Party: University Hospital Hradec Kralove Identifier: NCT04772703    
Other Study ID Numbers: CVV_COVID-19_DNA
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Organ Failure
Pathologic Processes