NCT04331054

Brief Summary

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

April 13, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

March 29, 2020

Last Update Submit

July 31, 2021

Conditions

Covid-19 InfectionHospitalization in Respiratory Disease Department

Keywords

Covid-19AsthmaInhaled steroidsFormoterolOxygen

Outcome Measures

Primary Outcomes (1)

  • Time (in days) to clinical improvement within 30 days after randomization

    Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death. These parameters will be evaluated daily during hospitalization.

    within 30 days

Secondary Outcomes (11)

  • Mortality rate at D30

    At day30

  • Time (in days) from randomization to death

    up to 30 days after randomization

  • Number of days alive outside ICU within 30 days

    At day30

  • Number of days alive free of invasive or non-invasive ventilation within 30 days

    At day30

  • Number of days alive with oxygen therapy within 30 days

    At day30

  • +6 more secondary outcomes

Study Arms (2)

1: Usual practice

ACTIVE COMPARATOR

arm will be follow during 30 days

Other: 1: Usual practice

2: Usual practice + SYMBICORT RAPIHALER

EXPERIMENTAL

Usual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days)

Drug: 2: Usual practice + SYMBICORT RAPIHALER

Interventions

2: Usual practice + SYMBICORT RAPIHALERDRUG

2 puffs bid during 30 days by inhalation

2: Usual practice + SYMBICORT RAPIHALER
1: Usual practiceOTHER

Usual practice

1: Usual practice

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Current treatment with any inhaled steroid (any other form of steroid administration does not exclude the patient)
  • Intensive care unit is required for the patient (based on investigator judgement)
  • Patient with cognitive impairment which do not guarantee proper use of the treatment by the patient himself
  • Contraindications to the treatments (history of hypersensitivity)
  • Patient admitted for isolation, for social reason or due to comorbidities without gravity sign
  • Long-term patient treated with digitalis, disopyramide, procainamide or phenothiazine that could lengthen the QT space

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bichat - Service de Pneumologie

Paris, 75010, France

Location

MeSH Terms

Conditions

COVID-19Asthma

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Camille TAILLE, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 2, 2020

Study Start

April 13, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

August 3, 2021

Record last verified: 2021-07

Locations

FR(1)