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Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Sponsor
Sara Varea (Other)
Overall Status
Completed
CT.gov ID
NCT04355637
Collaborator
(none)
120
Enrollment
14
Locations
2
Arms
14.3
Actual Duration (Months)
8.6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Inhaled budesonide
 Phase 4

Study Design

Study Type:
Interventional
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 :
Apr 21, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Proportion of patients in both arms fulfilling the criteria for treatment failure [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 [baseline, day 3, day 7, day 15, day 30]

    Yes/no

  2. ICU refusal [baseline, day3, day 7, day 15, day 30]

    yes/no and reason

  3. Occurrence of complications [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) [at baseline, day 3, day 7, day 15, day 30]

    U/L

  5. C Reactive Protein (CRP) [at baseline, day 3, day 7, day 15, day 30]

    mg/dL

  6. ferritin [at baseline, day 3, day 7, day 15, day 30]

    ng/mL

  7. D-dimer [at baseline, day 3, day 7, day 15, day 30]

    ng/mL

  8. leukocyte counts [at baseline, day 3, day 7, day 15, day 30]

    x10^9/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Infecciosas "Francisco Javier Muñiz" Ciudad Autonoma de Buenos Aires Buenos Aires Argentina C1282AEN
2 CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno") Ciudad Autonoma de Buenos Aires Buenos Aires Argentina C1425DQK
3 Hospital de Rehabilitación Respiratoria "María Ferrer" Ciudad Autónoma de Buenos Aires Buenos Aires Argentina C1272AAA
4 Hospital Donación "Francisco Santojanni" Ciudad Autónoma de Buenos Aires Buenos Aires Argentina C1408INH
5 Clínica Monte Grande Monte Grande Buenos Aires Argentina B1842
6 Hospital Centro de Salud Zenón J. Santillán San Miguel De Tucumán Tucumán Argentina T4000
7 Hospital San Juan de Dios La plata Argentina B1900
8 Hospital de Santiago Santiago De Compostela A Coruña Spain 15706
9 Hospital Universitari Germans Trias i Pujol Badalona Barcelona Spain 08916
10 Hospital Universitari de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
11 Hospital del Mar Barcelona Spain 08003
12 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
13 Hospital Clinic of Barcelona Barcelona Spain 08036
14 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041

Sponsors and Collaborators

  • Sara Varea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
First Posted:
Apr 21, 2020
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pneumonia
Coronavirus Infections
Budesonide

Study Results

No Results Posted as of Sep 22, 2021