STOIC: STerOids in COVID-19 Study

Sponsor

University of Oxford (Other)

Overall Status

Terminated

CT.gov ID

NCT04416399

Collaborator

(none)

146

Enrollment

Location

Arms

5.9

Actual Duration (Months)

24.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised, open label parallel group controlled clinical trialRandomised, 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

Actual Study Start Date :

Jul 16, 2020

Actual Primary Completion Date :

Jan 12, 2021

Actual Study Completion Date :

Jan 12, 2021

Arms and Interventions

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 Names: Pulmicort
No Intervention: Standard of care Standard of care

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 Names:

Pulmicort

No Intervention: Standard of care

Standard of care

Outcome Measures

Primary Outcome Measures

Emergency department attendance of hospitalisation related to COVID-19 [Day 1 to day 28]
Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19

Secondary Outcome Measures

Body temperature [Day 1 to day 14]
Evaluate the effect of intervention on body temperature
Blood oxygen saturation level [Day 1 to day 14]
Evaluate the effect of intervention on blood oxygen level
Symptoms as assessed by common cold questionnaire [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 [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 [Day 1, 7 and 14]
Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.