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Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Primary Purpose

Coronavirus Infection

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Inhaled budesonide

About this trial

This is an interventional treatment trial for Coronavirus Infection

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital de Infecciosas "Francisco Javier Muñiz"
CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
Hospital de Rehabilitación Respiratoria "María Ferrer"
Hospital Donación "Francisco Santojanni"
Clínica Monte Grande
Hospital Centro de Salud Zenón J. Santillán
Hospital San Juan de Dios
Hospital de Santiago
Hospital Universitari Germans Trias i Pujol
Hospital Universitari de Bellvitge
Hospital del Mar
Hospital Universitari Vall d'Hebron
Hospital Clinic of Barcelona
Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

patients receiving standard of care to treat their pneumonia

patients receiving standard of care to treat their pneumonia + inhaled budesonide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ICU admission

Yes/no

ICU refusal

yes/no and reason

Occurrence of complications

infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.

lactate dehydrogenase (LDH)

U/L

C Reactive Protein (CRP)

mg/dL

ferritin

ng/mL

D-dimer

ng/mL

leukocyte counts

x10^9/L

Full Information

NCT ID

NCT04355637

First Posted

April 15, 2020

Last Updated

September 21, 2021

Sponsor

Sara Varea

1. Study Identification

Unique Protocol Identification Number

NCT04355637

Brief Title

Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Official Title

Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 21, 2020 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sara Varea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

patients receiving standard of care to treat their pneumonia

Arm Title

Intervention

Arm Type

Experimental

Arm Description

patients receiving standard of care to treat their pneumonia + inhaled budesonide

Intervention Type

Drug

Intervention Name(s)

Inhaled budesonide

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients in both arms fulfilling the criteria for treatment failure

Description

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 Outcome Measure Information:

Title

ICU admission

Description

Yes/no

Time Frame

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

Title

ICU refusal

Description

yes/no and reason

Time Frame

baseline, day3, day 7, day 15, day 30

Title

Occurrence of complications

Description

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

Title

lactate dehydrogenase (LDH)

Description

U/L

Time Frame