Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04355637 |
Recruitment Status :
Completed
First Posted : April 21, 2020
Last Update Posted : September 22, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Infection | Drug: Inhaled budesonide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia |
Actual Study Start Date : | April 21, 2020 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
patients receiving standard of care to treat their pneumonia
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Experimental: Intervention
patients receiving standard of care to treat their pneumonia + inhaled budesonide
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Drug: Inhaled budesonide
adding budesonide to standard of care for pneumonia in COVID19 positive patients |
- 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
- ICU admission [ Time Frame: baseline, day 3, day 7, day 15, day 30 ]Yes/no
- ICU refusal [ Time Frame: baseline, day3, day 7, day 15, day 30 ]yes/no and reason
- Occurrence of complications [ Time Frame: baseline, day3, day 7, day 15, day 30 ]infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.
- lactate dehydrogenase (LDH) [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]U/L
- C Reactive Protein (CRP) [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]mg/dL
- ferritin [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]ng/mL
- D-dimer [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]ng/mL
- leukocyte counts [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]x10^9/L

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355637
Argentina | |
Hospital de Infecciosas "Francisco Javier Muñiz" | |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1282AEN | |
CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno") | |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DQK | |
Hospital de Rehabilitación Respiratoria "María Ferrer" | |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1272AAA | |
Hospital Donación "Francisco Santojanni" | |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1408INH | |
Clínica Monte Grande | |
Monte Grande, Buenos Aires, Argentina, B1842 | |
Hospital Centro de Salud Zenón J. Santillán | |
San Miguel De Tucumán, Tucumán, Argentina, T4000 | |
Hospital San Juan de Dios | |
La plata, Argentina, B1900 | |
Spain | |
Hospital de Santiago | |
Santiago De Compostela, A Coruña, Spain, 15706 | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Hospital Universitari de Bellvitge | |
Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Clinic of Barcelona | |
Barcelona, Spain, 08036 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08041 |
Responsible Party: | Sara Varea, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica |
ClinicalTrials.gov Identifier: | NCT04355637 |
Other Study ID Numbers: |
TACTIC-COVID 2020-001616-18 ( EudraCT Number ) |
First Posted: | April 21, 2020 Key Record Dates |
Last Update Posted: | September 22, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Coronavirus Infections Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Budesonide |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |