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IRCT20210725051981N1 IRCT 2021-10-19 Esfahan University of Medical Sciences Inhalation Ethanol therapy in COVID-19 Efficacy and safety of Ethanol inhalation on early stage of COVID-19 (a clinical trial study) 2021-10-26 anticipated 86 Complete https://irct.ir/trial/58201 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Randomization tool: Random number table Even and zero digits are assigned to the ethanol treatment group and odd numbers to the control group, Blinding description: The blinding of the participant is done by not telling him the name of the drug under study. Analysts and staff collecting the data are given questionnaires in two groups named A and B. 3 COVID-19. Intervention 1: Intervention group: In this group, in addition to the current treatment of Covid-19, which is remdesivir and methylprednisolone or dexamethasone, nebulizing ethanol is also added in this way. Four times a day, each time 10 ml of ethanol 70% of Sepahan bio-product CO. is poured in oxygen flowmeter or in the tank of the nebulizer device. After that, we add 10 ml of distilled water to it and encourage the patient to inhale it from mouth and nose. This technique must repeat for five days. Intervention 2: Control group: In this group, the current treatment of Covid-19, which is remdesivir and methylprednisolone or dexamethasone, is continued, and 20 ml of distilled water as placebo is poured into an oxygen flow meter or nebulizer, and the patient is encouraged to inhale it. Yes - There is a plan to make this available What will be shared: All data is shareable. When: Access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: It is permissible to use this data to find patients who respond better to this treatment. Where to obtain: Contact Ali Amoshahi by phone (00989131158298) or email (aliamoushah@gmail.com). How to obtain: The request will be answered in a week in consultation with other partners in the project. Comments:
public Elham Moazam
Shams Abadi
Isfahan Iran (Islamic Republic of) 8134735945 +98 31 3235 1541 el_moazam@yahoo.com Esfahan University of Medical Sciences scientific Ali Amoushahi
Ayneh Khane Avn.
Isfahan Iran (Islamic Republic of) 8164644370 +98 31 3667 6152 aliamoushah@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Positive RT-PCR test of SARS-COV2 Less than 7 days of starting of signs or symptoms of COVID-19 Age 15-69 yr 15 years 69 years Both Pregnancy History of Asthma History of Alcohol dependency History of Seizure Contraindication of Ethanol addministration Disagreement of patient physician U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: In this group, in addition to the current treatment of Covid-19, which is remdesivir and methylprednisolone or dexamethasone, nebulizing ethanol is also added in this way. Four times a day, each time 10 ml of ethanol 70% of Sepahan bio-product CO. is poured in oxygen flowmeter or in the tank of the nebulizer device. After that, we add 10 ml of distilled water to it and encourage the patient to inhale it from mouth and nose. This technique must repeat for five days. Control group: In this group, the current treatment of Covid-19, which is remdesivir and methylprednisolone or dexamethasone, is continued, and 20 ml of distilled water as placebo is poured into an oxygen flow meter or nebulizer, and the patient is encouraged to inhale it. Requires non-temporary hospitalization. Timepoint: Daily until 5 daus. Method of measurement: Counting the days. Needing to ICU admission. Timepoint: Days 7, 14, 21. Method of measurement: Evaluate medical file records. Mortality Rate. Timepoint: Days 7, 14, 21, 28. Method of measurement: Evaluate medical file records. Respiratory status of patients. Timepoint: ِDays from 1 to 5. Method of measurement: SPO2. Inflammatory condition. Timepoint: Days 1-5-14. Method of measurement: WBC counting -CRP titration. Clinical status. Timepoint: Days 1-5-14. Method of measurement: Score from the table of clinical signs. Esfahan University of Medical Sciences Approved 2021-09-25 Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Isfahan University of Medical Sciences,Isfahan,Iran Isfahan Isfehan Iran (Islamic Republic of)