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NCT04375137 Clinical Trial

Correlation Between Oxidative Stress Status and COVID-19 Severity

Oxidative Stress Clinical Trial

Official title:
Correlation Between Oxidative Stress Markers and COVID-19 Severity Index

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04375137
Other study ID # SBMU.12543
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2020
Est. completion date May 30, 2022

Study information
Verified date July 2023
Source Shahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date May 30, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Oxidative Stress ELISA Kit
Checking oxidative stress markers and redox system status

Locations
Country Name City State
Iran, Islamic Republic of Nooshin Dalili Tehran

Sponsors (1)
Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary MDA concentration MDA x 2 ULN in severe COVID 2 weeks
Secondary Biopterin concentration Difference between severe and controls 2 weeks
Secondary Neopterin rate of increase Difference between severe and controls 2 weeks
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