Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Phase 4

Completed

• Conditions: Coronavirus Infection
• Interventions: Drug: Inhaled budesonide

• 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

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-17
• Study Start: 2020-04-21
• Study First Posted: 2020-04-21
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

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

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
ferritin	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
leukocyte counts	at baseline, day 3, day 7, day 15, day 30	x10\^9/L

Trial Locations

Locations (14)

Hospital San Juan de Dios; 🇦🇷 La plata, Argentina

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Clínica Monte Grande; 🇦🇷 Monte Grande, Buenos Aires, Argentina

Hospital de Santiago; 🇪🇸 Santiago De Compostela, A Coruña, Spain

CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"); 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Centro de Salud Zenón J. Santillán; 🇦🇷 San Miguel De Tucumán, Tucumán, Argentina

Hospital Donación "Francisco Santojanni"; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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

Hospital de Rehabilitación Respiratoria "María Ferrer"; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain