NCT04772703

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

February 25, 2021

Last Update Submit

September 25, 2022

Conditions

Covid19Organ Failure, MultipleDNA Damage

Outcome Measures

Primary Outcomes (2)

  • single-stranded DNA breaks

    Changes in the single-stranded DNA breaks in peripheral lymphocytes

    One week

  • oxidation of DNA bases

    Changes in oxidised purine and pyrimidine bases of peripheral lymphocytes DNA

    One week

Secondary Outcomes (1)

  • Mortality

    One month

Interventions

COMET ASSAYDIAGNOSTIC_TEST

The description in the detailed description of the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • rejection by the patient to sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

Location

MeSH Terms

Conditions

COVID-19Multiple Organ Failure

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

February 26, 2021

Study Start

November 23, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)