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STerOids in COVID-19 Study (STOIC)

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ClinicalTrials.gov Identifier: NCT04416399
Recruitment Status : Terminated (Independent statistical review advice)
First Posted : June 4, 2020
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE July 16, 2020
Actual Primary Completion Date January 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
Emergency department attendance of hospitalisation related to COVID-19 [ Time Frame: Day 1 to day 28 ]
Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Body temperature [ Time Frame: Day 1 to day 14 ]
    Evaluate the effect of intervention on body temperature
  • Blood oxygen saturation level [ Time Frame: Day 1 to day 14 ]
    Evaluate the effect of intervention on blood oxygen level
  • Symptoms as assessed by common cold questionnaire [ Time Frame: Day 1 to day 14 ]
    Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.
  • Symptoms as assessed by FluPro questionnaire [ Time Frame: Day 1 to day 14 ]
    Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.
  • Nasal/throat swab SARS-CoV-2 viral load [ Time Frame: Day 1, 7 and 14 ]
    Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STerOids in COVID-19 Study
Official Title  ICMJE Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation
Brief Summary

At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus.

Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells.

Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible.

The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised, open label parallel group controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Infection
Intervention  ICMJE Drug: Budesonide dry powder inhaler
Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
Other Name: Pulmicort
Study Arms  ICMJE
  • Experimental: Inhaled budesonide
    Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
    Intervention: Drug: Budesonide dry powder inhaler
  • No Intervention: Standard of care
    Standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 3, 2021)
146
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2020)
478
Actual Study Completion Date  ICMJE January 12, 2021
Actual Primary Completion Date January 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the trial
  • Male or Female, aged 18 years or above
  • New onset of symptoms suggestive of COVID-19 e.g. new onset cough and/or fever, and/or loss of smell or taste within 7 or fewer days of participant being seen at visit 1
  • In the Investigator's opinion, is able and willing to comply with all trial requirements

Exclusion Criteria:

  • A known allergy to investigational medicine product (IMP) (budesonide)
  • Any known contraindication to any of the IMPs (budesonide)
  • Patient currently prescribed inhaled or systemic corticosteroids
  • Recent use, within the previous 7 days of inhaled or systemic corticosteroids
  • Patient needs hospitalisation at time of study consent
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04416399
Other Study ID Numbers  ICMJE STOIC study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mona Bafadhel, MBBS, PhD University of Oxford
PRS Account University of Oxford
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP