Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
- 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
- COVID19 positive
- hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
- without contraindications to receive study treatment
- informed consent
- 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
Group Intervention Description Intervention Inhaled budesonide patients receiving standard of care to treat their pneumonia + inhaled budesonide
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method C Reactive Protein (CRP) at baseline, day 3, day 7, day 15, day 30 mg/dL
D-dimer at baseline, day 3, day 7, day 15, day 30 ng/mL
ICU admission baseline, day 3, day 7, day 15, day 30 Yes/no
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
ferritin 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
Related Research Topics
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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
Scroll for more (4 remaining)Hospital de Infecciosas "Francisco Javier Muñiz"🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina