EUCTR2020-005280-31-ES
Active, Not Recruiting
Phase 1
Phase IV, single-center, randomized and open-label study to evaluate the impact of early treatment with a combination of an inhaled corticosteroid and a long-acting ß2 adrenergic agonist (budesonide / formoterol) versus standard of care on the evolution of the disease in vulnerable patients with COVID-19: INHALAVID Trial
Fundació Eurecat0 sites200 target enrollmentFebruary 1, 2021
ConditionsEnfermedad en pacientes vulnerables con COVID-19MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsBiresp Spiromax
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Enfermedad en pacientes vulnerables con COVID-19
- Sponsor
- Fundació Eurecat
- Enrollment
- 200
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients capable of understanding the terms of the trial and agreeing to participate on it.
- •2\. Patients who sign the informed consent or oral consent with subsequent written confirmation.
- •3\. Patients \= 65 years of age or \= 50 years with a documented diagnosis in the medical history of at least one of the following comorbidities: arterial hypertension (diagnosed in the medical history and under treatment with antihypertensive drugs, cardiovascular disease, obesity (BMI \> 30\), diabetes, COPD, or active cancer.
- •4\. Positive antigen test for SARS\-CoV\-2\.
- •5\. Less than 10 days from the appearance of the first symptoms at the time of randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 200
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\. Current treatment with inhaled beta\-adrenergic blockers (including eye drops), corticosteroids, or beta 2 \-agonists for any indication.
- •2\. Patients with contraindications for the use of budesonide / formoterol: hypersensitivity to the active substances or to the excipient included, lactose monohydrate, or in case of active pulmonary tuberculosis.
- •3\. Patients with a previous history of cardiac arrhythmias (eg, atrial fibrillation, supraventricular tachycardia, and extrasystoles).
- •4\. Patients who are participating in another clinical trial.
- •5\. Pregnant or lactating women.
- •6\. Women and men of childbearing potential who are unwilling to use an effective contraceptive method (such as oral contraceptives, intrauterine device, or barrier method of contraception along with spermicide or surgical sterilization), during the study.
Outcomes
Primary Outcomes
Not specified
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