Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
NCT ID: NCT04355637
Last Updated: 2021-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2020-04-21
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
patients receiving standard of care to treat their pneumonia
No interventions assigned to this group
Intervention
patients receiving standard of care to treat their pneumonia + inhaled budesonide
Inhaled budesonide
adding budesonide to standard of care for pneumonia in COVID19 positive patients
Interventions
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Inhaled budesonide
adding budesonide to standard of care for pneumonia in COVID19 positive patients
Eligibility Criteria
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Inclusion Criteria
* hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
* without contraindications to receive study treatment
* informed consent
Exclusion Criteria
* 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
18 Years
79 Years
ALL
No
Sponsors
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Sara Varea
OTHER
Responsible Party
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Sara Varea
Clinical Research Manager
Locations
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Hospital de Infecciosas "Francisco Javier Muñiz"
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
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
Clínica Monte Grande
Monte Grande, Buenos Aires, Argentina
Hospital Centro de Salud Zenón J. Santillán
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital San Juan de Dios
La Plata, , Argentina
Hospital de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic of Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2020-001616-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TACTIC-COVID
Identifier Type: -
Identifier Source: org_study_id
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