Morality Clinical Trial
— COVID-19Official title:
Inhalational Ethanol Therapy (Spray and Nebulized ETHO) in COVID-19 Treatment
Verified date | April 2022 |
Source | Isfahan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 16, 2021 |
Est. primary completion date | November 16, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 77 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Isabn-e-Maryam Hospital | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Ali Amoushahi | Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Respiratory status | Blood oxygen saturation monitored with pulse oximetry | day 0 | |
Other | Respiratory status | Blood oxygen saturation monitored with pulse oximetry | day 3 | |
Other | Respiratory status | Blood oxygen saturation monitored with pulse oximetry | day 7 | |
Other | Respiratory status | Blood oxygen saturation monitored with pulse oximetry | day 14 | |
Other | Inflammatory factor (CRP) | WBC counting -CRP titration | day 0 | |
Other | Inflammatory factor (CRP) | WBC counting -CRP titration | day 7 | |
Other | Adverse events | Follow-up the participants regarding Ethanol adverse events including: hiccups, eye irritation, cough, shortness of breath, sneezing and unpleasant odor of alcohol. | day 0 | |
Other | Adverse events | Follow-up the participants regarding Ethanol adverse events including: hiccups, eye irritation, cough, shortness of breath, sneezing and unpleasant odor of alcohol. | day 7 | |
Other | Adverse events | Follow-up the participants regarding Ethanol adverse events including: hiccups, eye irritation, cough, shortness of breath, sneezing and unpleasant odor of alcohol. | day 14 | |
Other | Requires hospitalization | Counting the days | day 7 | |
Other | Requires hospitalization | Counting the days | day 14 | |
Other | Requires hospitalization | Counting the days | day 30 | |
Other | Needing to ICU admission | Evaluate medical file records | Day 7 | |
Other | Needing to ICU admission | Evaluate medical file records | Day 14 | |
Other | Needing to ICU admission | Evaluate medical file records | Day 30 | |
Other | Mortality Rate | Evaluate medical file records | Day 7 | |
Other | Mortality Rate | Evaluate medical file records | Day 14 | |
Other | Mortality Rate | Evaluate medical file records | Day 30 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Clinical Status Scale | Clinical status based on the modified 7-point ordinal scale are included:
Death (Lowest scale means the worse outcome) Hospitalized, on invasive mechanical ventilation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring low flow supplemental oxygen Hospitalized, for whatever reason, - requiring ongoing medical care (COVID-19 related or otherwise), requiring supplemental oxygen at home Continue signs or symptoms of COVID-19 without requiring supplemental oxygen - no longer requires ongoing medical care Complete recovery (maximum value means the best scale) |
day 14th |
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