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STerOids in COVID-19 Study (STOIC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416399
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Budesonide dry powder inhaler Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, open label parallel group controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation
Estimated Study Start Date : June 11, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Inhaled budesonide
Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
Drug: Budesonide dry powder inhaler
Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
Other Name: Pulmicort

No Intervention: Standard of care
Standard of care



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Body temperature [ Time Frame: Day 1 to day 14 ]
    Evaluate the effect of intervention on body temperature

  2. Blood oxygen saturation level [ Time Frame: Day 1 to day 14 ]
    Evaluate the effect of intervention on blood oxygen level

  3. 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.

  4. 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.

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04416399


Contacts
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Contact: Mona Bafadhel, MBBS, PhD (+44) (0) 1865 612897 mona.bafadhel@ndm.ox.ac.uk
Contact: Magda Laskawiec magda.laskawiec@ouh.nhs.uk

Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Mona Bafadhel, MBBS, PhD University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04416399    
Other Study ID Numbers: STOIC study
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Oxford:
CoVID-19
Coronavirus infection
SARS-CoV-2
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract 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