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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355637
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : September 22, 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)
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

Resource links provided by the National Library of Medicine

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


Locations
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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
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: September 22, 2021
Last Verified: September 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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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