STerOids in COVID-19 Study

Coronavirus Infection Clinical Trial

— STOIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04416399
• Other study ID #: STOIC study
• Status: Terminated
• Phase: Phase 2
• Start date: July 16, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: July 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Oxford Respiratory Trials Unit	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergency department attendance of hospitalisation related to COVID-19	Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19	Day 1 to day 28
Secondary	Body temperature	Evaluate the effect of intervention on body temperature	Day 1 to day 14
Secondary	Blood oxygen saturation level	Evaluate the effect of intervention on blood oxygen level	Day 1 to day 14
Secondary	Symptoms as assessed by common cold questionnaire	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
Secondary	Symptoms as assessed by FluPro questionnaire	Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.	Day 1 to day 14
Secondary	Nasal/throat swab SARS-CoV-2 viral load	Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load	Day 1, 7 and 14