Oxidative StressNCT04375137
Correlation Between Oxidative Stress Status and COVID-19 Severity
An observational study of Oxidative Stress, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Oxidative Stress ELISA Kit
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- 20 Apr 2020to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Severe COVID:Hypoxic intubated Non-severe COVID: non-hypoxic in ward Healthy Controls
Who may be able to join
- more than 18 years old
- positive RT-PCR COVID-19
- compatible lung CT with COVID-19
Who cannot join
- not signing informed consent
- using antioxidants
- using statins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oxidative Stress
- Being tested
- Oxidative Stress ELISA Kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidative Stress ELISA KitDiagnostic test
Checking oxidative stress markers and redox system status
| Study group | Role | What they receive |
|---|---|---|
| Severe COVID | patients with positive PCR or compatible CT admitted in ICU or intubated Receives: Diagnostic Test: Oxidative Stress ELISA Kit | |
| Non-severe COVID-19 | patients with positive PCR or compatible CT admitted in ward without hypoxia Receives: Diagnostic Test: Oxidative Stress ELISA Kit | |
| Healthy Controls | Healthy controls with negative IgM/IgG for COVID-19 Receives: Diagnostic Test: Oxidative Stress ELISA Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDA concentration
MDA x 2 ULN in severe COVID
Measured: 2 weeks
Secondary outcomes (2)
Biopterin concentration
Difference between severe and controls
Measured: 2 weeks
Neopterin rate of increase
Difference between severe and controls
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start20 Apr 2020
- Primary completion1 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- Dalili, Principal investigator, SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375137
- Sponsor's protocol ID
- SBMU.12543
- Status last verified
- Jul 2023
- First submitted
- 3 May 2020
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Oxidative Stress Markers and COVID-19 Severity Index
- ClinicalTrials.gov ID
- NCT04375137
- Acronym / sponsor ID
- SBMU.12543
- Conditions
- Oxidative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe COVID | – | Diagnostic Test: Oxidative Stress ELISA Kitpatients with positive PCR or compatible CT admitted in ICU or intubated |
| Non-severe COVID-19 | – | Diagnostic Test: Oxidative Stress ELISA Kitpatients with positive PCR or compatible CT admitted in ward without hypoxia |
| Healthy Controls | – | Diagnostic Test: Oxidative Stress ELISA KitHealthy controls with negative IgM/IgG for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Severe COVID:Hypoxic intubated Non-severe COVID: non-hypoxic in ward Healthy Controls
Key inclusion criteria (3 listed)
- more than 18 years old
- positive RT-PCR COVID-19
- compatible lung CT with COVID-19
Key exclusion criteria (3 listed)
- not signing informed consent
- using antioxidants
- using statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxidative Stress ELISA KitChecking oxidative stress markers and redox system status | Diagnostic test | Healthy Controls, Non-severe COVID-19, Severe COVID |
Primary outcome
MDA concentration
Time frame: 2 weeks
MDA x 2 ULN in severe COVID
2 secondary outcomes
Biopterin concentration
Time frame: 2 weeks
Neopterin rate of increase
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalili principal investigator
SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDA concentration (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.