drugset
drugset / Trial / NCT04570254

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

NCT04570254 ↗

Completed 110 enrolled Unidad Temporal COVID-19 en Centro Citibanamex Instituto Nacional de Cardiologia Ignacio Chavez · collabInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · collab
Non-randomizedParallel-groupTriple-blindTreatment

Summary

Introduction: SARS-CoV2 infection produces severe pneumonia with pulmonary alveolar collapse. There is no specific treatment to date. In experimental models and humans with septic shock, there is a high production of nitric oxide (NO) and reactive nitrogen species (RNS) and can cause multiple organ failure. The administration of antioxidants such as n-acetylcysteine (NAC), vitamin C, melatonin, and vitamin E participate in increasing the intracellular content of GSH, ROS sequestration, protection of the lipids of cell membranes, cytosol proteins, nuclear DNA, mitochondrial and decrease LPO. Justification: as there is no specific antiviral therapy, the therapeutic options are limited, complications and mortality are high; It is intended to evaluate the effect of antioxidants on the storm outcome of the dysregulation of oxidative stress. Hypothesis: It is postulated that adjuvant therapy with antioxidants and Pentoxifylline reduces the use of ventilators in patients with or without septic shock secondary to severe SARS-COV2 pneumonia as decreases lipoperoxidation, and corrects dysregulation of oxidative stress by increasing the antioxidant capacity. Objectives: To evaluate whether it is possible to avoid intubation or decrease assisted mechanical ventilation days, improve oxidative stress dysregulation in patients with SARS-COV2 infection with severe pneumonia with or without septic shock. Methodology: Quasi-experimental, open analytical, prospective, and longitudinal study (before-after). In patients over 18 years of age who are admitted to the CITIBANAMEX Center with or without septic shock secondary to severe SARS-COV2 pneumonia. There will be two groups: 1) patients without septic shock and 2) patients with septic shock secondary to severe pneumonia due to SARS-COV2. A single antioxidant will be applied following the clinical decision tree (NAC, Vit C, Vit E, melatonin) more Pentoxifylline orally or by orogastric tube for a total of 5 days from the start of the protocol. APACHE II will calculate the risk, SOFA, MEXSOFA, measurements of IL-8, vitamin C, NO3 / NO2, LOP, total antioxidant capacity will be carried out at baseline and 48 hours. SOFA will be calculated for seven days, in addition to days of hospitalization, days of mechanical ventilation. It was evaluated 28 days after discharge by telephone.

Timeline

Start
2020-08-19
Primary completion
2020-12-01
Completion
2020-12-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 50 mg —
Subject N-acetylcysteine Small molecule 600 mg —
Subject Pentoxifylline Small molecule 400 mg Oral
Subject Vitamin C Other / unclassified 1 g —
Subject Vitamin E Other / unclassified 800 mg —

Indications

COVID-19 acute respiratory distress syndrome viral pneumonia