EUCTR2020-001760-29-ES
Active, not recruiting
Phase 1
Phase II clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19. - ALCOVID-19
Sociedad Española de Farmacia Hospitalaria0 sites156 target enrollmentNovember 19, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Sociedad Española de Farmacia Hospitalaria
- Enrollment
- 156
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Institutionalized men or women aged 65 or over at the time of signing the informed consent.
- •2\. Patients capable of understanding the trial procedures and accepting their participation.
- •3\. Diagnosis of COVID\-19 confirmed by RT\-PCR.
- •4\. Initial stage of the disease diagnosed by:
- •\- Less than 7 days from the appearance of the first symptoms.
- •\- Absence of dyspnea
- •\- Absence of pneumonia
- •\- SO2\> 93% or pO2\> 70
- •\- FR \<25 rpm
- •5\. Signature and date of informed consent before any study\-related activity, including evaluations necessary for selection.
Exclusion Criteria
- •1\. Impaired kidney function (creatinine\> 2\.5 times the normal limit), need for haemofiltration or impaired liver function (ALT or AST\> 3 times the normal limits) or diagnosis of severe kidney failure.
- •2\. Hypersensitivity, allergy or contraindications to the study treatments.
- •3\. Inability to administer oxygen therapy using Ventimask®.
- •4\. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.
- •5\. Consumption of any other drug that could disable him in the judgment of the investigator to participate in the study.
- •6\. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.
- •7\. Participation in another clinical study where they received an investigational drug in the 24 weeks prior to signing the informed consent.
- •8\. Patients diagnosed with chronic bronchopneumopathy.
- •9\. Patients with a history of epilepsy.
- •10\. Patients with a history of alcoholism.
Outcomes
Primary Outcomes
Not specified
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