STerOids in COVID-19 Study (STOIC)

February 3, 2021 updated by: University of Oxford

Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Oxford Respiratory Trials Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
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 Names:
  • Pulmicort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 to day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: Day 1 to day 14
Evaluate the effect of intervention on body temperature
Day 1 to day 14
Blood oxygen saturation level
Time Frame: Day 1 to day 14
Evaluate the effect of intervention on blood oxygen level
Day 1 to day 14
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.
Day 1 to day 14
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.
Day 1 to day 14
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
Day 1, 7 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Mona Bafadhel, MBBS, PhD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2020

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOIC study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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