Correlation Between Oxidative Stress Status and COVID-19 Severity

July 15, 2023 updated by: nooshin dalili, Shahid Beheshti University of Medical Sciences

Correlation Between Oxidative Stress Markers and COVID-19 Severity Index

During the new COVID-19 pandemic physicians all over the world have faced different challenges .Oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in COVID-19 infection to the best of knowledge.Present study aimed to evaluate oxidative stress marker and redox system status in different COVID-19 patients regarding the severity of involvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in COVID-19 infection to the best of knowledge.Present study aimed to evaluate oxidative stress marker and redox system status in different COVID-19 patients regarding the severity of involvement. Demographic and lab data of 60 COVID-19 confirmed positive cases gathered .These patients divided in to two arms: 1- severe COVID-19 which were intubated or admitted in intensive care unit due to severe hypoxia 2- non-severe COVID-19 patients which were not hypoxic and admitted in ward with no need to invasive oxygenation. All patients had positive RT-PCR positive nasopharyngeal swab results for COVID-19 or Lung CT scan compatible with COVID-19. Malondialdehyde(MDA) , Biopterin, Neopterin, SOD, Glutathione levels would be checked by ELISA tests and compared between these two groups and healthy controls.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Severe COVID:Hypoxic intubated Non-severe COVID: non-hypoxic in ward Healthy Controls

Description

Inclusion Criteria:

  • more than 18 years old
  • positive RT-PCR COVID-19
  • compatible lung CT with COVID-19

Exclusion Criteria:

  • not signing informed consent
  • using antioxidants
  • using statins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe COVID
patients with positive PCR or compatible CT admitted in ICU or intubated
Diagnostic test: Oxidative Stress ELISA Kit
Checking oxidative stress markers and redox system status
Non-severe COVID-19
patients with positive PCR or compatible CT admitted in ward without hypoxia
Diagnostic test: Oxidative Stress ELISA Kit
Checking oxidative stress markers and redox system status
Healthy Controls
Healthy controls with negative IgM/IgG for COVID-19
Diagnostic test: Oxidative Stress ELISA Kit
Checking oxidative stress markers and redox system status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDA concentration
Time Frame: 2 weeks
MDA x 2 ULN in severe COVID
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biopterin concentration
Time Frame: 2 weeks
Difference between severe and controls
2 weeks
Neopterin rate of increase
Time Frame: 2 weeks
Difference between severe and controls
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Dalili, SBMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SBMU.12543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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