Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

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
• Conditions: Coronavirus Infection
• Intervention / Treatment: Drug: Inhaled budesonide

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • 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
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Drug: 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	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	Yes/no	baseline, day 3, day 7, day 15, day 30
ICU refusal	yes/no and reason	baseline, day3, day 7, day 15, day 30
Occurrence of complications	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)	U/L	at baseline, day 3, day 7, day 15, day 30
C Reactive Protein (CRP)	mg/dL	at baseline, day 3, day 7, day 15, day 30
ferritin	ng/mL	at baseline, day 3, day 7, day 15, day 30
D-dimer	ng/mL	at baseline, day 3, day 7, day 15, day 30
leukocyte counts	x10^9/L	at baseline, day 3, day 7, day 15, day 30

Collaborators and Investigators

• Sponsor: Sara Varea

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Lancet Respir Med. 2021 Jun;9(6):e55.
• 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.

Study record dates

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

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Coronavirus Infections; Pneumonia; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: TACTIC-COVID; 2020-001616-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No