EUCTR2020-005280-31-ESActive, not recruitingPhase 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 enrollmentStarted: February 1, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Efficacy of Bilastin in reduction of histaine-induce skin reactivity in healthy volunteers under fasted and fed conditions.ALLERGIC RHINOCONJUNTIVIS AND CHRONIC URTICARIAEUCTR2018-000913-19-ESFAES FARMA, S.A.24
Active, not recruiting
Phase 1
This study compares clinically and microscopically the response to two treatments, a steroid in cream and a foam that contains a steroid and a vitamin D analogue in patients with plaque psoriasis.Plaque psoriasisEUCTR2017-004451-24-ESFundació Clínic per a la Reserca Biomèdica36
Active, not recruiting
Not Applicable
Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)EUCTR2005-001026-89-DESerono GmbH100
Completed
Phase 4
Immunogenicity and safety of Rabies Vaccine, adimistered with two different simulated post exposure regimensCTRI/2011/07/001857ovartis Healthcare Pvt Ltd250
Active, not recruiting
Not Applicable
A phase IV, randomized, open-label, multi-center study in adults: Evaluation of long-term immunogenicity in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer) in study V48P2E1, 5 years after first booster immunization and Evaluation of booster kinetics in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer), 5 years after first booster immunization. - not availableTBE prophylaxisEUCTR2005-004459-36-DEChiron Behring GmbH & Co KG190