Clinical trial NCT04355637: Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
Official title: Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronavirus Infection
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients in both arms fulfilling the criteria for treatment failure
timeFrame: 15 days after treatment
Secondary outcomes:
measure: ICU admission
timeFrame: baseline, day 3, day 7, day 15, day 30
measure: ICU refusal
timeFrame: baseline, day3, day 7, day 15, day 30
measure: Occurrence of complications
timeFrame: baseline, day3, day 7, day 15, day 30
measure: lactate dehydrogenase (LDH)
timeFrame: at baseline, day 3, day 7, day 15, day 30
measure: C Reactive Protein (CRP)
timeFrame: at baseline, day 3, day 7, day 15, day 30
measure: ferritin
timeFrame: at baseline, day 3, day 7, day 15, day 30
measure: D-dimer
timeFrame: at baseline, day 3, day 7, day 15, day 30
measure: leukocyte counts
timeFrame: at baseline, day 3, day 7, day 15, day 30
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital de Infecciosas "Francisco Javier Muñiz"
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital de Rehabilitación Respiratoria "María Ferrer"
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Donación "Francisco Santojanni"
state: Buenos Aires
city: Monte Grande
country: Argentina
facility: Clínica Monte Grande
state: Buenos Aires
city: San Miguel De Tucumán
country: Argentina
facility: Hospital Centro de Salud Zenón J. Santillán
state: Tucumán
city: La plata
country: Argentina
facility: Hospital San Juan de Dios
city: Santiago De Compostela
country: Spain
facility: Hospital de Santiago
state: A Coruña
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: 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.
citation: Agusti 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.
citation: Farne 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.
citation: Nicolau 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.