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Trial · NCT04570254

Antioxidants as Adjuvant Therapy to Standard Therapy in Patients With COVID-19

NCT04570254, Not applicable, Completed, Unidad Temporal COVID-19 en Centro Citibanamex

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Antioxidants as Adjuvant Therapy to Standard Therapy in Patients With COVID-19. Trials, record NCT04570254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04570254

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Antioxidants as Adjuvant Therapy to Standard Therapy in Patients With COVID-19
NCT number
NCT04570254
Status
Completed
Phases
Not applicable
Enrollment
110 participants, actual
Lead sponsor
Unidad Temporal COVID-19 en Centro Citibanamex
Conditions
Pneumonia, Viral, Covid19, ARDS, Oxidative Stress
Interventions
Vitamin C, Vitamin E, Melatonin, N-acetyl cysteine, Pentoxifylline
First posted
2020-09-30
Last updated
2021-05-21

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDeath from any causeFrom admission to discharge, up to 30 days.It will be evaluated whether secondary to SARS-COV2 pneumonia, the outcome of the patient is dead.
PrimaryPercentage of patients who required orotracheal intubationFrom admission to discharge, up to 1 weekThe percentage of patients with SARS-COV2 pneumonia in whom orotracheal intubation was avoided will be evaluated.
PrimaryAssisted mechanical ventilationFrom admission to discharge, up to 1 weekIt will be evaluated if it is possible to reduce the days of mechanical ventilation
PrimaryStay in an intensive care unitFrom admission to discharge, up to 1 weekThe number of days of stay in the intensive care unit will be evaluated.
SecondaryMeasure lipoperoxidation in basal and post-therapy samplesBaseline and 5 days post-dose
For the measurement of lipid peroxidation, 50 µL of CH3-OH with 4% BHT plus a phosphate buffer pH 7.4 was added to 100 µL of plasma. The mixture was vigorously vortexed for 5 seconds and subsequently incubated in a water bath at 37 ° C for 30 minutes. 1.5 mL of 0.8 M tribarbituric acid was added to the sample, which was incubated in a water bath with boiling temperature for one hour. After this time and to stop the reaction, the sample was placed on ice; 1 mL 5% KCl was added to each sample, as was 4 mL of n-butanol; The sample was vortexed for 30 seconds and centrifuged at 4000 rpm at room temperature for 2 min. Subsequently, the butanol phase was extracted, and the absorbance at 532 nm was measured. The calibration curve was obtained using tetra ethoxy propane as a standard.
SecondaryEvaluation of the total antioxidant capacityBaseline and 5 days post-dose
100 mL of plasma was suspended in 1.5 mL of a reaction mixture prepared as follows: 300 mM of acetate buffer with pH 3.6, 20 mM of ferric chloride hexahydrate, and 10 mM of 2,4,6-Tris-2- Pyridyl-s-triazine dissolved in 40 mM hydrochloric acid in a ratio 10: 1: 1 v / v, respectively. The mixture was vigorously vortexed for 5 seconds. It was incubated at 37 ° C for 15 min in the dark. The absorbance was measured at 593 nm. The calibration curve was obtained using Trolox
SecondaryOxidative and antioxidant stressBaseline and 5 days post-dose
For the measurement of NO3- / NO2-, 100 µl of plasma were added 100 µL of a 10% solution of ZnSO4, 100 µL of 0.5 N NaOH and 700 µl of tridestated water. It was shaken vigorously and centrifuged at 10,000 rpm for 5 minutes. To the resulting supernatant, Griess reagent (200 µL of 1% sulfanilamide and 200 µL of 1% N- (1-naphthyl) ethylenediamine hydrochloride) was added and incubated for 10 min protected from light at room temperature. The coloration developed after incubation was measured at an analytical wavelength of 540 nm in a double beam UV-Vis spectrometer (DW2000, SLM-Aminco, Urbana, Illinois, USA). The calibration curve was performed with a KNO3 stock solution (Spectrum Quality Products, Inc., Gardena CA) in a concentration range from 0.001 nM to 10 nM.
SecondaryEffect of antioxidant therapy at the level on organ failure secondary to SARS-COV2From day 0 to day 7 post antioxidant dose.
Measurements will be made using the Sequential Organ Failure Assessment (SOFA) every 24 hours. With a minimum score of 0-1 which translates a mortality in initial score and the highest of 0%. The maximum score of more than 14 translates a mortality of 95.2% in the initial evaluation and 89.7% in the highest evaluation.
SecondaryEffect of antioxidant therapy at the level on organ failure secondary to SARS-COV2From day 0 to day 7 post antioxidant dose.
Measurements will be made using the Mexico Sequential Organ Failure Assessment (MEXSOFA) every 24 hours. highest evaluation. Patients with an initial MEXSOFA score of 9 points or less calculated during the first 24 hours after admission to the ICU had a mortality rate of 14.8%, while those with an initial MEXSOFA score of 10 points or more had a mortality rate. 40% mortality rate. The MEXSOFA score at 48 h was also associated with mortality: patients with a score of 9 points or less had a mortality rate of 14.1%, while those with a score of 10 points or more had a rate of 50% mortality.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers30

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
7010958BACKGROUNDPubMed
8706483RESULTPubMed
8844239RESULTPubMed
9272682RESULTPubMed
10488881RESULTPubMed
10924859RESULTPubMed
14605526RESULTPubMed
15001333BACKGROUNDPubMed
15364625BACKGROUNDPubMed
16247103BACKGROUNDPubMed

1 to 10 of 30

See all 30 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04570254

GET https://conductscience.org/api/trials/v1/NCT04570254/papers?page=2