Study to evaluate the impact of early treatment with a budesonide / formoterol versus standard of care on the evolution of the disease in vulnerable patients with COVID-19: INHALAVID Trial

Phase 1

• Conditions: Enfermedad en pacientes vulnerables con COVID-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005280-31-ES
• Lead Sponsor: Fundació Eurecat

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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
F.1.3.1 Number of subjects for this age range 200

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified