Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
![]() |
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04355637 |
Recruitment Status :
Recruiting
First Posted : April 21, 2020
Last Update Posted : January 12, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Infection | Drug: Inhaled budesonide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 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 |
Estimated Primary Completion Date : | August 31, 2021 |
Estimated Study Completion Date : | August 31, 2021 |

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 |
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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
Contact: Alvar Agusti | +34932271701 | aagusti@clinic.cat | |
Contact: Rosa Faner | +34932275400 | RFANER@clinic.cat |
Argentina | |
Hospital de Infecciosas "Francisco Javier Muñiz" | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1282AEN | |
Contact: Gastón De Stéfano, MD PhD +54 911 6028-4268 gastondes@hotmail.com | |
CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno") | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DQK | |
Contact: Ricardo Valentini, MD PhD +54 911 6203-6790 rvalentini@cemic.edu.ar; deptomedicina2@gmail.com | |
Hospital de Rehabilitación Respiratoria "María Ferrer" | Not yet recruiting |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1272AAA | |
Contact: Ricardo del Olmo, MD PhD +54 911 5414-3028 docdelolmo@gmail.com | |
Hospital Donación "Francisco Santojanni" | Recruiting |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1408INH | |
Contact: Fernando Saldarini, MD PhD +54 911 3703-0712 fernando.saldarini@gmail.com | |
Clínica Monte Grande | Not yet recruiting |
Monte Grande, Buenos Aires, Argentina, B1842 | |
Contact: Xavier Bocca Ruiz, MD,PhD 54 9 11 43676875 xbocca@gmail.com | |
Hospital Centro de Salud Zenón J. Santillán | Not yet recruiting |
San Miguel De Tucumán, Tucumán, Argentina, T4000 | |
Contact: Héctor H Altieri, MD PhD +54 9 3814 437837 hhaltieri@gmail.com | |
Hospital San Juan de Dios | Recruiting |
La plata, Argentina, B1900 | |
Contact: Andrés Echazarreta, MD PhD +54 9221 507-8358 neumosanjuan@gmail.com; aechaza@gmail.com; | |
Spain | |
Hospital Universitari Germans Trias i Pujol | Recruiting |
Badalona, Barcelona, Spain, 08916 | |
Contact: Alicia Marin amarin.germanstrias@gencat.cat | |
Principal Investigator: Alicia Marin | |
Hospital Universitari de Bellvitge | Recruiting |
Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Contact: Salud Santos ssantosp@bellvitgehospital.cat | |
Sub-Investigator: Jordi Dorca Sargatal | |
Principal Investigator: Salud Santos | |
Hospital de Sabadell-Parc Tauli | Not yet recruiting |
Sabadell, Barcelona, Spain, 08208 | |
Contact: Daniel Ross Monserrate drmonserrate@tauli.cat | |
Principal Investigator: Daniel Ross Monserrate | |
Hospital del Mar | Recruiting |
Barcelona, Spain, 08003 | |
Contact: Joaquim Gea Giralt JGea@parcdesalutmar.cat | |
Principal Investigator: Joaquim Gea Giralt | |
Sub-Investigator: Sergi Pascual | |
Hospital Universitari Vall d'Hebron | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Jaume Ferrer Sancho jjferrer@vhebron.net | |
Principal Investigator: Jaume Ferrer Sancho | |
Sub-Investigator: Xavier Muñoz | |
Hospital Clinic of Barcelona | Recruiting |
Barcelona, Spain, 08036 | |
Contact: ALVAR AGUSTI +34932271701 AAGUSTI@CLINIC.CAT | |
Contact: ROSA FANER +34932275400 RFANER@clinic.cat | |
Principal Investigator: ALVAR AGUSTI, MD, PhD | |
Sub-Investigator: ORIOL SIBILA, MD, PhD | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08041 | |
Contact: Vicente Plaza VPlaza@santpau.cat | |
Principal Investigator: Vicente Plaza |
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: | January 12, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections 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 |