Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Sara Varea120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Coronavirus Infection

Interventions

Inhaled budesonideDRUG

adding budesonide to standard of care for pneumonia in COVID19 positive patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (14)

Hospital de Infecciosas "Francisco Javier Muñiz"

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Outcomes

Primary Outcomes

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

Time frame: 15 days after treatment

Secondary Outcomes

ICU admission

Yes/no

Time frame: baseline, day 3, day 7, day 15, day 30

ICU refusal

yes/no and reason

Time frame: 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.

Time frame: baseline, day3, day 7, day 15, day 30

lactate dehydrogenase (LDH)

U/L

Time frame: at baseline, day 3, day 7, day 15, day 30

C Reactive Protein (CRP)

mg/dL

Time frame: at baseline, day 3, day 7, day 15, day 30

ferritin

ng/mL

Time frame: at baseline, day 3, day 7, day 15, day 30

D-dimer

ng/mL

Time frame: at baseline, day 3, day 7, day 15, day 30

leukocyte counts

Data from ClinicalTrials.gov

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