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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
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Inhaled budesonide Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids
Drug Information available for: Budesonide

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. ICU admission [ Time Frame: baseline, day 3, day 7, day 15, day 30 ]
    Yes/no

  2. ICU refusal [ Time Frame: baseline, day3, day 7, day 15, day 30 ]
    yes/no and reason

  3. 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.

  4. lactate dehydrogenase (LDH) [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]
    U/L

  5. C Reactive Protein (CRP) [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]
    mg/dL

  6. ferritin [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]
    ng/mL

  7. D-dimer [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]
    ng/mL

  8. leukocyte counts [ Time Frame: at baseline, day 3, day 7, day 15, day 30 ]
    x10^9/L


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Alvar Agusti +34932271701 aagusti@clinic.cat
Contact: Rosa Faner +34932275400 RFANER@clinic.cat

Locations
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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         
Sponsors and Collaborators
Sara Varea
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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