DNA Damage in Critically Ill COVID-19 Patients
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|ClinicalTrials.gov Identifier: NCT04772703|
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment|
|Covid19 Organ Failure, Multiple DNA Damage||Diagnostic Test: COMET ASSAY|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|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|
- Diagnostic Test: COMET ASSAY
The description in the detailed description of the study
- single-stranded DNA breaks [ Time Frame: One week ]Changes in the single-stranded DNA breaks in peripheral lymphocytes
- oxidation of DNA bases [ Time Frame: One week ]Changes in oxidised purine and pyrimidine bases of peripheral lymphocytes DNA
- Mortality [ Time Frame: One month ]All cause 30-day mortality
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 ClinicalTrials.gov identifier (NCT number): NCT04772703
|Contact: Zdeněk Zadák, prof., M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: David Astapenko, M.D., Ph.D.||+email@example.com|