Treating COVID-19 infections with inhaled corticosteroids

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 478

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 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 478

Exclusion Criteria

-A known allergy to IMP (budesonide)
-Any known contraindication to the IMP (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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effect of inhaled corticosteroid (ICS) therapy compared to standard care in participants with early CoVID-19 illness in reducing COVID related emergency department presentations and/or hospital admissions.;Secondary Objective: Evaluate the effect of ICS therapy on body temperature, blood oxygen saturation level, viral load, and symptoms compared to standard care in participants with early CoVID-19 illness.;Primary end point(s): Hospitalisation or emergency department attendance related to COVID-19.;Timepoint(s) of evaluation of this end point: Day 0 to 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1)Body temperature and blood oxygen saturation level <br>2)Nasal/throat swab SARS-CoV-2 viral load <br>3)Common cold questionnaire and FluPRO questionnaire;Timepoint(s) of evaluation of this end point: 1)Day 0 to day 28<br>2)Day 0, 7 and 14<br>3)Day 0 to day 28<br>