Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Drug: Inhaled budesonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>patients receiving standard of care to treat their pneumonia | |
| Experimental: Intervention<br>patients receiving standard of care to treat their pneumonia + inhaled budesonide | Drug: Inhaled budesonide<br>* adding budesonide to standard of care for pneumonia in COVID19 positive patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in both arms fulfilling the criteria for treatment failure | 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 | 15 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU admission | Yes/no | baseline, day 3, day 7, day 15, day 30 | 
| ICU refusal | yes/no and reason | baseline, day3, day 7, day 15, day 30 | 
| Occurrence of complications | infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale. | baseline, day3, day 7, day 15, day 30 | 
| lactate dehydrogenase (LDH) | U/L | at baseline, day 3, day 7, day 15, day 30 | 
| C Reactive Protein (CRP) | mg/dL | at baseline, day 3, day 7, day 15, day 30 | 
| ferritin | ng/mL | at baseline, day 3, day 7, day 15, day 30 | 
| D-dimer | ng/mL | at baseline, day 3, day 7, day 15, day 30 | 
| leukocyte counts | x10^9/L | at baseline, day 3, day 7, day 15, day 30 |