Phase III clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19.
- Conditions
- COVID-19Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001760-29-ES
- Lead Sponsor
- Sociedad Española de Farmacia Hospitalaria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>2. To evaluate the evolution of the viral load of the patients in the nasopharyngeal sample during the treatment period and subsequent follow-up.<br><br>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.<br><br>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 Outcome Measures
Name Time Method