Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia
2 other identifiers
interventional
120
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2020
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedStudy Start
First participant enrolled
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedSeptember 22, 2021
September 1, 2021
1.2 years
April 15, 2020
September 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
ICU admission
baseline, day 3, day 7, day 15, day 30
ICU refusal
baseline, day3, day 7, day 15, day 30
Occurrence of complications
baseline, day3, day 7, day 15, day 30
lactate dehydrogenase (LDH)
at baseline, day 3, day 7, day 15, day 30
C Reactive Protein (CRP)
at baseline, day 3, day 7, day 15, day 30
- +3 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONpatients receiving standard of care to treat their pneumonia
Intervention
EXPERIMENTALpatients receiving standard of care to treat their pneumonia + inhaled budesonide
Interventions
adding budesonide to standard of care for pneumonia in COVID19 positive patients
Eligibility Criteria
You may qualify if:
- COVID19 positive
- hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
- without contraindications to receive study treatment
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Varealead
Study Sites (14)
Hospital de Infecciosas "Francisco Javier Muñiz"
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1282AEN, Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DQK, Argentina
Hospital de Rehabilitación Respiratoria "María Ferrer"
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1272AAA, Argentina
Hospital Donación "Francisco Santojanni"
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1408INH, Argentina
Clínica Monte Grande
Monte Grande, Buenos Aires, B1842, Argentina
Hospital Centro de Salud Zenón J. Santillán
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
Hospital San Juan de Dios
La Plata, B1900, Argentina
Hospital de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic of Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Related Publications (4)
Agusti A, De Stefano G, Levi A, Munoz X, Romero-Mesones C, Sibila O, Lopez-Giraldo A, Plaza Moral V, Curto E, Echazarreta AL, Marquez SE, Pascual-Guardia S, Santos S, Marin A, Valdes L, Saldarini F, Salgado C, Casanovas G, Varea S, Rios J, Faner R. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J. 2022 Mar 10;59(3):2103036. doi: 10.1183/13993003.03036-2021. Print 2022 Mar.
PMID: 35144989DERIVEDAgusti A, Torres F, Faner R. Early treatment with inhaled budesonide to prevent clinical deterioration in patients with COVID-19. Lancet Respir Med. 2021 Jul;9(7):682-683. doi: 10.1016/S2213-2600(21)00171-5. Epub 2021 Apr 9. No abstract available.
PMID: 33844998DERIVEDFarne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.
PMID: 33388170DERIVEDNicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.
PMID: 32738928DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Research Manager
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 21, 2020
Study Start
April 21, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
September 22, 2021
Record last verified: 2021-09