Efficacy and Safety of Ethanol Inhalation on COVID-19 Treatment (a Clinical Trial Study)

NCT05268419 | Completed Phase 3 DMC

• 3 other identifiers: IRCT20210725051981N1U07.1COVID-19, virus identified
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Infection; Outcome; Morality

Keywords

COVID-19; Ethanol; Inhalation; Nebulizer

Outcome Measures

Primary Outcomes (4)

• Global Symptomatic Score

  Global Symptomatic Score (GSS) is considered as an indicator of clinical status of the participants. These included: Fever, Chills, Cough, Headache, Short Breath, Sore throat, Runny nose, Body pain, Anorexia, Anosmia and Lack of taste. Maximum score (6.67) is the worse and minimum score (1.34) mean a better outcome.

  day 0

• Global Symptomatic Score

  Global Symptomatic Score (GSS) is considered as an indicator of clinical status of the participants. These included: Fever, Chills, Cough, Headache, Short Breath, Sore throat, Runny nose, Body pain, Anorexia, Anosmia and Lack of taste. Maximum score (6.67) is the worse and minimum score (1.34) mean a better outcome.

  day 3

• Global Symptomatic Score

  Global Symptomatic Score (GSS) is considered as an indicator of clinical status of the participants. These included: Fever, Chills, Cough, Headache, Short Breath, Sore throat, Runny nose, Body pain, Anorexia, Anosmia and Lack of taste. Maximum score (6.67) is the worse and minimum score (1.34) mean a better outcome.

  day 7

• Global Symptomatic Score

  Global Symptomatic Score (GSS) is considered as an indicator of clinical status of the participants. These included: Fever, Chills, Cough, Headache, Short Breath, Sore throat, Runny nose, Body pain, Anorexia, Anosmia and Lack of taste. Maximum score (6.67) is the worse and minimum score (1.34) mean a better outcome.

  day 14th

Secondary Outcomes (1)

• Clinical Status Scale

  day 14th

Other Outcomes (18)

• Respiratory status

  day 0

• Respiratory status

  day 3

• Respiratory status

  day 7

Study Arms (2)

Ethanol inhalation

ACTIVE COMPARATOR

100 ml spray of 35% ethanol were provided and all of participants were instructed to use spray three times every 6 hours from a distance of 20-30 cm from their face, while wearing a mask and closing their eyes, and take a deep breath as they feel nebulized liquid droplets in their nose, mouth, throat, larynx and lungs. Investigators emphasized participants that this protocol must be repeated every six hours to 7 days.

Drug: Ethanol

Water Distilled inhalation

PLACEBO COMPARATOR

100 ml spray of water distilled (placebo) were provided and all of participants were instructed to use spray three times every 6 hours from a distance of 20-30 cm from their face, while wearing a mask and closing their eyes, and take a deep breath as they feel nebulized liquid droplets in their nose, mouth, throat, larynx and lungs. Investigators emphasized participants that this protocol must be repeated every six hours to 7 days.

Drug: Water Distilled

Interventions

Ethanol DRUG

Inhalation of 35%-ethanol spray

Also known as: Ethyl Alcohol

Ethanol inhalation

Water Distilled DRUG

Inhalation of water distilled spray

Also known as: Water for Injection,Sterile,30Ml

Water Distilled inhalation

Eligibility Criteria

• Age: 12 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Intolerance to inhaled ethanol
• Hypersensitivity
• Allergies to ethanol
• Use of drugs that interact with ethanol
• Partial or incomplete treatment

Sponsors & Collaborators

• Ali Amoushahi: lead
• Isfahan University of Medical Sciences: collaborator

Study Sites (1)

Isabn-e-Maryam Hospital

Isfahan, 8134735945, Iran

Location

MeSH Terms

Conditions

Communicable Diseases; COVID-19; Respiratory Aspiration

Interventions

Ethanol; Water; Injections

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Elham Moazam, Researcher

  Chief of Research center of hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding was performed at the level of participants, clinicians, Investigator, nurses and analysts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology and Critical Care Specialist

Model Details: Based on the "treatment-on" or "protocol per" strategy, analysis was limited to participants who, according to the study protocol and inclusion criteria, received full interventions and informed the outcomes.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 7, 2022
• Study Start: September 2, 2021
• Primary Completion: November 16, 2021
• Study Completion: December 16, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will become available 6 months after publication.
• Access Criteria: It will be available only to researchers working in academic and scientific institutions. It is permissible to use this data to find patients who respond better to this treatment.

Locations

IR (1)