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Trial - NCT04554433


Column Value
Trial registration number NCT04554433
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04554433

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Ragab

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Dr.ezz2712@gmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-18

Recruitment status
Last imported at : Oct. 5, 2022, 7:30 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - age from 20 - 60 - confirmed covid-19 positive with pcr test . - admitted to mansoura university quarantine hospital .. - fever ≥ 38 - respiratory rate ≥ 20 - myalgia , arthralgia and sore throat . - radiological findings consisting with covid-19 . - welling to participate and able to give fully informed consent. specific inclusion criteria according to the concentration and method :- - inhalation of alcohol vapor driven by oxygen respiratory distress ( dyspnea - orthopnea ) spo2 : 65 - 85 abg : respiratory alkalosis due to dyspnea and tachypnea pao2 / fio2 ratio > 300 mmhg under the condition in the hospital room (moderate illness). - inhalation of alcohol vapor driven by oxygen in case of ards. respiratory failure . ct : lobar collapse and nodules non cardiogenic pulmonary edema excluded by echo or signs of overload . pao2 / fio2 ratio 101 - 300 mmhg on cpap or vent . ( mild to moderate ards) - ethyl alcohol infusion into the airway pao2 / fio2 ratio ≤ 100 mmhg ( sever ards )

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- absence of any item from inclusion criteria - pregnancy . - signs of dehydration , sepsis or shortness of breathing. - asthmatic patients . - copd . - smokers ≥ 10 years . - hypersensitivity to alcohol

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mansoura University

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

20

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

60

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

80

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Disinfection of COVID-19 in human respiratory tract .

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2266, "treatment_name": "Aspirin+ethanol", "treatment_type": "Coagulation modifiers+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]