An observational study in Covid19, Organ Failure, Multiple and DNA Damage, sponsored by University Hospital Hradec Kralove. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by University Hospital Hradec Kralove · Observational
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.
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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 10 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
The description in the detailed description of the study
single-stranded DNA breaks
Changes in the single-stranded DNA breaks in peripheral lymphocytes
Time frame: One week
oxidation of DNA bases
Changes in oxidised purine and pyrimidine bases of peripheral lymphocytes DNA
Time frame: One week
Mortality
All cause 30-day mortality
Time frame: One month
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in Feb 2021, 3 months.
Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 3 months is below that.
Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Hradec Kralove