Correlation Between Oxidative Stress Status and COVID-19... | NCT04375137

Studies
Correlation Between Oxidative Stress Status and COVID-19 Severity

NCT04375137

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Jul 18, 2023Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Oxidative Stress

Interventions

Oxidative Stress ELISA Kit

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2020Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

May 30, 2022Actual

First Submitted Date

May 3, 2020

First Submission Date that Met QC Criteria

May 3, 2020

First Posted Date

May 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2023

Last Update Posted Date

Jul 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nooshin dalili, Principal Investigator, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Severe COVID	patients with positive PCR or compatible CT admitted in ICU or intubated	Diagnostic Test: Oxidative Stress ELISA Kit
Non-severe COVID-19	patients with positive PCR or compatible CT admitted in ward without hypoxia	Diagnostic Test: Oxidative Stress ELISA Kit
Healthy Controls	Healthy controls with negative IgM/IgG for COVID-19	Diagnostic Test: Oxidative Stress ELISA Kit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxidative Stress ELISA Kit	Diagnostic Test	Checking oxidative stress markers and redox system status	Healthy Controls Non-severe COVID-19 Severe COVID

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dalili	SBMU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nooshin Dalili		Tehran			Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided