Inhalational Ethanol Therapy (Spray and Nebulized ETHO) in COVID-19 Treatment

• Status: Completed
• Trial end date: 2021-12-16
• Target enrollment: 0
• Participant gender: All

Summary

Cytokine storm is the cause of many deaths in COVID -19. The antiviral in-vitro effects of ethanol with solving the fat layer and destroying the glycoprotein of coronavirus have already been established. Proven antiviral effects of ethyl alcohol on extracellular surfaces have been demonstrated by researchers. Immunological studies have shown that acute administration of ethanol can have immunomodulatory effects on innate immunity system mediated by TNFamRNA protein and mitogen-activated protein kinas and reduce cytokine storm by reducing inflammatory factors such as -TLR, TLR, TL-9, interleukin-6 and TL9. It also helps with the chemotaxis of bronchoalveolar macrophages. Other demonstrated effects of ethanol are including: inhibition of virus replication by inhibition of RNA-dependent polymerase, the bronchial dilation by relaxing their involuntary smooth muscles, sedating and relaxation of the participant, muscular analgesic effects.

Ethanol administration has previously been reported for the treatment of methanol poisoning, fat embolism, prevention of preterm labor, pre-eclampsia, and pulmonary edema. The histological safety of inhalation ethanol therapy in the lungs and respiratory tracts of rabbits has been shown by Anna Castro-Balado et al. Ethanol is approved by the Food and Drug Administration. Given these effects of ethanol on virus wall destruction, inhibition of proliferation, and inhibition of immune hyperactivity, the question now is, "Can ethanol inhalation therapy be effective in controlling COVID-19?" There is no a prior knowledge of the inhalation ethanol therapy in COVID-19. This idea was first suggested and published one month after COVID-19 pandemic in Iran (February 2020). To find the answer, a clinical trial was conducted to evaluate the effectiveness of ethanol therapy on clinical state and prognosis of participants. The study was approved by the Medical University of Isfahan, research and ethics committees and is registered at https://irct.ir/trial/58201.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ali Amoushahi
• Collaborator: Isfahan University of Medical Sciences
• Treatments: Ethanol

Criteria

Inclusion Criteria:

• Positive RT-PCR test Less than seven days from onset of symptoms

• Agreeing to implement the plan in the form of informed consent

• Age over 12 years

• Not pregnant

• No history of asthma

• Alcoholism

• Epilepsy

• No contraindications to ethanol

Exclusion Criteria:

• Pregnancy

• Intolerance to inhaled ethanol

• Hypersensitivity

• Allergies to ethanol

• Use of drugs that interact with ethanol

• Partial or incomplete treatment