Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Coronavirus Infection Clinical Trial

Official title:

Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355637
• Other study ID #: TACTIC-COVID
• Secondary ID: 2020-001616-18
• Status: Completed
• Phase: Phase 4
• Start date: April 21, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Pneumonia

Intervention

Drug:
• Inhaled budesonide
adding budesonide to standard of care for pneumonia in COVID19 positive patients

Locations

Country	Name	City	State
Argentina	CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")	Ciudad Autonoma 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 Donación "Francisco Santojanni"	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Hospital San Juan de Dios	La plata
Argentina	Clínica Monte Grande	Monte Grande	Buenos Aires
Argentina	Hospital Centro de Salud Zenón J. Santillán	San Miguel De Tucumán	Tucumán
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital de Santiago	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Sara Varea

Countries where clinical trial is conducted

Argentina,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 days after treatment
Secondary	ICU admission	Yes/no	baseline, day 3, day 7, day 15, day 30
Secondary	ICU refusal	yes/no and reason	baseline, day3, day 7, day 15, day 30
Secondary	Occurrence of complications	infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.	baseline, day3, day 7, day 15, day 30
Secondary	lactate dehydrogenase (LDH)	U/L	at baseline, day 3, day 7, day 15, day 30
Secondary	C Reactive Protein (CRP)	mg/dL	at baseline, day 3, day 7, day 15, day 30
Secondary	ferritin	ng/mL	at baseline, day 3, day 7, day 15, day 30
Secondary	D-dimer	ng/mL	at baseline, day 3, day 7, day 15, day 30
Secondary	leukocyte counts	x10^9/L	at baseline, day 3, day 7, day 15, day 30