- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355637
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
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
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La plata, Argentina, B1900
- Hospital San Juan de Dios
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1282AEN
- Hospital de Infecciosas "Francisco Javier Muñiz"
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DQK
- CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno")
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1272AAA
- Hospital de Rehabilitación Respiratoria "María Ferrer"
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1408INH
- Hospital Donación "Francisco Santojanni"
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Monte Grande, Buenos Aires, Argentina, B1842
- Clinica Monte Grande
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Tucumán
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San Miguel De Tucumán, Tucumán, Argentina, T4000
- Hospital Centro de Salud Zenón J. Santillán
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Barcelona, Spain, 08003
- Hospital del Mar
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Barcelona, Spain, 08036
- Hospital Clinic of Barcelona
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebrón
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Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau
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A Coruña
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Santiago De Compostela, A Coruña, Spain, 15706
- Hospital de Santiago
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
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Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
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-
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
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adding budesonide to standard of care for pneumonia in COVID19 positive patients
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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
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ICU refusal
Time Frame: baseline, day3, day 7, day 15, day 30
|
yes/no and reason
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baseline, day3, day 7, day 15, day 30
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Occurrence of complications
Time Frame: baseline, day3, day 7, day 15, day 30
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infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.
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baseline, day3, day 7, day 15, day 30
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lactate dehydrogenase (LDH)
Time Frame: at baseline, day 3, day 7, day 15, day 30
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U/L
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at baseline, day 3, day 7, day 15, day 30
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C Reactive Protein (CRP)
Time Frame: at baseline, day 3, day 7, day 15, day 30
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mg/dL
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at baseline, day 3, day 7, day 15, day 30
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ferritin
Time Frame: at baseline, day 3, day 7, day 15, day 30
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ng/mL
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at baseline, day 3, day 7, day 15, day 30
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D-dimer
Time Frame: at baseline, day 3, day 7, day 15, day 30
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ng/mL
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at baseline, day 3, day 7, day 15, day 30
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leukocyte counts
Time Frame: at baseline, day 3, day 7, day 15, day 30
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x10^9/L
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at baseline, day 3, day 7, day 15, day 30
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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.
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
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
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
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.
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