STerOids in COVID-19 Study

Overview

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.

Full Title of Study: “Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 12, 2021

Interventions

  • Drug: Budesonide dry powder inhaler
    • Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day

Arms, Groups and Cohorts

  • Experimental: Inhaled budesonide
    • Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
  • No Intervention: Standard of care
    • Standard of care

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oxford
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mona Bafadhel, MBBS, PhD, Principal Investigator, University of Oxford

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