Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia
Overview
- Phase
- Phase 4
- Intervention
- Inhaled budesonide
- Conditions
- Coronavirus Infection
- Sponsor
- Sara Varea
- Enrollment
- 120
- Locations
- 14
- Primary Endpoint
- Proportion of patients in both arms fulfilling the criteria for treatment failure
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.
Investigators
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
Eligibility Criteria
Inclusion Criteria
- •COVID19 positive
- •hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
- •without contraindications to receive study treatment
- •informed consent
Exclusion Criteria
- •receiving corticoids (inhaled or systemic)
- •receiving anti Interleukin-1 (IL-1) or anti-IL-6 drugs
- •receiving high flow oxygen therapy
- •receiving mechanical ventilation
- •pregnancy
- •participating in another intervention trial for COVID19
Arms & Interventions
Intervention
patients receiving standard of care to treat their pneumonia + inhaled budesonide
Intervention: Inhaled budesonide
Outcomes
Primary Outcomes
Proportion of patients in both arms fulfilling the criteria for treatment failure
Time Frame: 15 days after treatment
composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation and/or death) at day 15 after initiation of therapeutic intervention
Secondary Outcomes
- ferritin(at baseline, day 3, day 7, day 15, day 30)
- C Reactive Protein (CRP)(at baseline, day 3, day 7, day 15, day 30)
- D-dimer(at baseline, day 3, day 7, day 15, day 30)
- ICU admission(baseline, day 3, day 7, day 15, day 30)
- ICU refusal(baseline, day3, day 7, day 15, day 30)
- Occurrence of complications(baseline, day3, day 7, day 15, day 30)
- lactate dehydrogenase (LDH)(at baseline, day 3, day 7, day 15, day 30)
- leukocyte counts(at baseline, day 3, day 7, day 15, day 30)