Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

September 21, 2021 updated by: Sara Varea

Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • La plata, Argentina, B1900
        • Hospital San Juan de Dios
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1282AEN
        • Hospital de Infecciosas "Francisco Javier Muñiz"
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DQK
        • CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1272AAA
        • Hospital de Rehabilitación Respiratoria "María Ferrer"
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1408INH
        • Hospital Donación "Francisco Santojanni"
      • Monte Grande, Buenos Aires, Argentina, B1842
        • Clinica Monte Grande
    • Tucumán
      • San Miguel De Tucumán, Tucumán, Argentina, T4000
        • Hospital Centro de Salud Zenón J. Santillán
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Hospital de Santiago
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
patients receiving standard of care to treat their pneumonia
Experimental: Intervention
patients receiving standard of care to treat their pneumonia + inhaled budesonide
adding budesonide to standard of care for pneumonia in COVID19 positive patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in both arms fulfilling the criteria for treatment failure
Time Frame: 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
15 days after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronavirus Infection

Clinical Trials on Inhaled budesonide

3
Subscribe