NCT04375137

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

May 3, 2020

Last Update Submit

July 15, 2023

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (1)

  • MDA concentration

    MDA x 2 ULN in severe COVID

    2 weeks

Secondary Outcomes (2)

  • Biopterin concentration

    2 weeks

  • Neopterin rate of increase

    2 weeks

Study Arms (3)

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

Oxidative Stress ELISA KitDIAGNOSTIC_TEST

Checking oxidative stress markers and redox system status

Healthy ControlsNon-severe COVID-19Severe COVID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • not signing informed consent
  • using antioxidants
  • using statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nooshin Dalili

Tehran, Iran

Location

Study Officials

  • Dalili

    SBMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 5, 2020

Study Start

April 20, 2020

Primary Completion

April 1, 2022

Study Completion

May 30, 2022

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)