MedPath

Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Phase 4
Completed
Conditions
Coronavirus Infection
Interventions
Registration Number
NCT04355637
Lead Sponsor
Sara Varea
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionInhaled budesonidepatients receiving standard of care to treat their pneumonia + inhaled budesonide
Primary Outcome Measures
NameTimeMethod
Proportion of patients in both arms fulfilling the criteria for treatment failure15 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 Outcome Measures
NameTimeMethod
C Reactive Protein (CRP)at baseline, day 3, day 7, day 15, day 30

mg/dL

D-dimerat baseline, day 3, day 7, day 15, day 30

ng/mL

ICU admissionbaseline, day 3, day 7, day 15, day 30

Yes/no

ICU refusalbaseline, day3, day 7, day 15, day 30

yes/no and reason

Occurrence of complicationsbaseline, 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

ferritinat baseline, day 3, day 7, day 15, day 30

ng/mL

leukocyte countsat baseline, day 3, day 7, day 15, day 30

x10\^9/L

Trial Locations

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

Hospital de Rehabilitación Respiratoria "María Ferrer"

🇦🇷

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Donación "Francisco Santojanni"

🇦🇷

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Clínica Monte Grande

🇦🇷

Monte Grande, Buenos Aires, Argentina

Hospital Centro de Salud Zenón J. Santillán

🇦🇷

San Miguel De Tucumán, Tucumán, Argentina

Hospital San Juan de Dios

🇦🇷

La plata, Argentina

Hospital de Santiago

🇪🇸

Santiago De Compostela, A Coruña, Spain

Hospital Universitari Germans Trias i Pujol

🇪🇸

Badalona, Barcelona, Spain

Hospital Universitari de Bellvitge

🇪🇸

Hospitalet de Llobregat, Barcelona, Spain

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Hospital de Infecciosas "Francisco Javier Muñiz"
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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