NCT05268419 (COVID-19) is a Phase 3 clinical trial of Ethanol in Clinical Infection, sponsored by Ali Amoushahi.

Who is sponsoring NCT05268419?

NCT05268419 is sponsored by Ali Amoushahi.

What drugs are being tested in NCT05268419?

Interventions in NCT05268419: Ethanol, Water Distilled.

What condition does NCT05268419 study?

NCT05268419 studies Clinical Infection, Outcome, Morality.

Is NCT05268419 still recruiting?

NCT05268419 is currently completed. Last updated 25 April 2022.

Last reviewed 2022-04-25 · How we verify

NCT05268419: COVID-19

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 25 April 2022

What this trial tests

Phase 3 trial testing Ethanol in Clinical Infection in 150 participants. Completed in 16 December 2021.

Timeline

2 September 2021

Primary endpoint
16 November 2021

16 December 2021

Quick facts

Lead sponsor	Ali Amoushahi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	150
Start date	2 September 2021
Primary completion	16 November 2021
Estimated completion	16 December 2021
Sites	1 location across Iran

Drugs / interventions tested

Ethanol (Ethanol) — full drug profile →
Water Distilled — full drug profile →

Conditions studied

Clinical Infection — all drugs for Clinical Infection →
Outcome — all drugs for Outcome →
Morality — all drugs for Morality →

Sponsor

Ali Amoushahi — full company profile →

Who can join

Adults 12 to 77, any sex, with Clinical Infection or Outcome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ethanol

Trials testing the same drug.

NCT06819189 — Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors · Phase 1 · recruiting
NCT06559878 — Hepatic Mitochondrial Metabolism in Fatty Liver Disease in Humans · NA · enrolling by invitation
NCT06065657 — Effect of Nutritional Ketosis on Alcohol Metabolism · Phase 2, PHASE3 · active not recruiting
NCT06091189 — Internalized Stress in Relation to Alcohol Consumption · EARLY_PHASE1 · terminated
NCT06143059 — The Effects of Sex Hormones and Alcohol on Sleep · Phase 3 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05268419 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ali Amoushahi
Last refreshed: 25 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05268419.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing