STerOids in COVID-19 Study

Study Overview
=================
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.

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

Conditions
-----------------
Coronavirus Infection

Intervention / Treatment
-----------------
* Drug: Budesonide dry powder inhaler


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, open label parallel group controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled budesonide<br>Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day | Drug: Budesonide dry powder inhaler<br>* Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day<br>* Other names: Pulmicort;|
| No Intervention: Standard of care<br>Standard of care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | Evaluate the effect of intervention on body temperature | Day 1 to day 14 | 
| Blood oxygen saturation level | Evaluate the effect of intervention on blood oxygen level | Day 1 to day 14 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CoVID-19, Coronavirus infection, SARS-CoV-2