COVID-19
Conditions
Interventions
Product Name: Fórmula magistral de etanol 65º
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: Ethanol
CAS Number: 64-17-5
Current Sponsor code: Ethanol
Other descriptive name: ETHANOL
Sponsors
Sociedad Española de Farmacia Hospitalaria
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 156
Exclusion criteria
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. 11. Treatment with anticonvulsant drugs used for the treatment of epilepsy and with a higher degree of interaction with ethanol: topiramate, carbamazepine, perampanel and stiripentol 12. Treatment with drugs that administered concomitantly with ethanol can cause the so-called “disulfiran-like effect”: disulfiran, metronidazole, tinidazole, chloramphenicol, levamisole, nitrofurantoin, isoniazid and griseofulvin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the progression to more serious stages defined by pneumonia, respiratory distress, sepsis, septic shock or death at 14 days and 28 days of follow-up (according to the Spanish Ministry of Health classification of disease severity);Secondary Objective: 1. Evaluate the evolution of hypoxemia using the SaO2 / FiO2 index with respect to the nadir at 1, 2 and 4 weeks. 2. To evaluate the evolution of the viral load of the patients in the nasopharyngeal sample during the treatment period and subsequent follow-up. 3. Evaluate the number of patients who normalize body temperature, defined as axillary temperature <37.5 °, without antipyretic treatment for at least 48 hours on the 5th day of treatment. 4. Evaluate the safety of administering the experimental treatment.;Primary end point(s): Progression data: date and symptoms of progression;Timepoint(s) of evaluation of this end point: Days 0, +13 and +27 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Admission data: date and symptoms on admission on day 0. - Viral load by real-time quantitative RT-PCR in oropharyngeal sample on days 0, +4, +9, +13, +20 and +27. - Need for hospital admission and its duration - Death: date and cause on the end of study day. - Risk factors: presence of advanced age, cancer, cardiovascular disease, hypertension, diabetes, COPD, bronchial asthma, obesity and chronic treatments on day 0. - Blood oxygen level: arterial oxygen saturation (SaO2) measured first thing in the morning, and inspiratory fraction of oxygen (FiO2) on days 0, +4, +9, +13, +20 and +27. - Body temperature: axillary temperature on days 0, + 1, + 2, +4. - Antipyretic treatment on day 0, +1, +2 and +4. - Basic analytics on days 0, +4 - Analytical determination ethanol day +4 - ECG abnormalities - Symptoms of bronchospasm after administration of each inhalation. - Adverse events on days 0 to +27.;Timepoint(s) of evaluation of this end point: Days 0, +1, +2, +4, +9, +13, +20 y +27. | — |
Countries
Spain
Contacts
Public ContactAlejandro Guerra Hidalgo
C.R.O. Delos Clinical
Outcome results
None listed