COVID 19
Conditions
Interventions
Trade Name: Budesonide
Product Name: Budesonide
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Budesonide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration numbe
Sponsors
University of Oxford, Clinical Trials and Research Governance
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Body temperature and blood oxygen saturation level 2)Nasal/throat swab SARS-CoV-2 viral load 3)Common cold questionnaire and FluPRO questionnaire;Timepoint(s) of evaluation of this end point: 1)Day 0 to day 28 2)Day 0, 7 and 14 3)Day 0 to day 28 | — |
Countries
United Kingdom
Contacts
Public ContactMagda Laskawiec-Szkonter
Oxford Respiratory Trials Unit
Outcome results
None listed