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

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.

Conditions

• Pneumonia, Viral
• Covid19
• ARDS
• Oxidative Stress

Interventions

DRUG

Vitamin C

Vitamin C. Tablet of 1 gr. A dose of 1 gr every 12 hours. Dissolve one tablet in a volume of 30 ml of water and administer it immediately, then rinse the glass with 10 ml of water and administer it to the patient. Protect from light at all times, as it is photosensitive.

DRUG

Vitamin E

Vitamin E. 800 mg tablet. 800 mg dose every 24 hours. Dissolve the capsule in 30 ml of hot water. The administration of vitamin E is recommended during or after meals since its absorption depends on pancreatic enzymes' presence.

DRUG

Melatonin

Melatonin Tablet 5 mg. A dose of 50 mg every 24 hours. Grind the 10 5 mg melatonin tablets (50 mg), levitate with 50 mL of Ora-plus (Transferring to a beaker with a magnetic stirrer). Maintain gentle agitation. "Rinse" the mortar with 10 mL of Ora-sweet. Add 30 mL of Ora sweet to the glass where the mixture is being made. Makeup with Ora-sweet cbp 100 mL Place label FL02 with legend Melatonin 50 mg / 20 mL. Protected from light (Dispense in a black bag that covers the transparent bag of the preparation)'s primary packaging) Give after breakfast.

DRUG

N-acetyl cysteine

N-acetylcysteine. Tablets, 600 mg. 600 mg dose every 12 hours. Dissolve one tablet in a volume of 30 ml of water and administer it immediately, then rinse the glass with 10 ml of water and administer it to the patient.

DRUG

Pentoxifylline

Pentoxifylline. 400 mg tablets. 400 mg dose every 12 hours. The tablet is dissolved in 30 ml of water and is administered orally or nasogastric tube.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez

  collaborator OTHER

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  collaborator OTHER

• Unidad Temporal COVID-19 en Centro Citibanamex

  lead OTHER

Principal Investigators

• Maria Elena Soto Lopez, PhD · [email protected]

• Adrián Palacios Chavarria, MD · Unidad Temporal COVID-19 en Centro Citibanamex

• José Guillermo Domínguez Cherit, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-19

Primary Completion

2020-12-01

Completion

2020-12-01

Countries

• Mexico

Study Locations