Coronavirus Infection
Conditions
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.
Interventions
adding budesonide to standard of care for pneumonia in COVID19 positive patients
Sponsors
Sara Varea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in both arms fulfilling the criteria for treatment failure | 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
| Measure | Time frame | Description |
|---|---|---|
| ICU refusal | baseline, day3, day 7, day 15, day 30 | yes/no and reason |
| Occurrence of complications | baseline, day3, day 7, day 15, day 30 | infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale. |
| lactate dehydrogenase (LDH) | at baseline, day 3, day 7, day 15, day 30 | U/L |
| ICU admission | baseline, day 3, day 7, day 15, day 30 | Yes/no |
| ferritin | at baseline, day 3, day 7, day 15, day 30 | ng/mL |
| D-dimer | at baseline, day 3, day 7, day 15, day 30 | ng/mL |
| leukocyte counts | at baseline, day 3, day 7, day 15, day 30 | x10\^9/L |
| C Reactive Protein (CRP) | at baseline, day 3, day 7, day 15, day 30 | mg/dL |
Countries
Argentina, Spain
Outcome results
None listed