se of inhaled corticosteroids as treatment of early COVID-19 infection to prevent clinical deterioration and hospitalisation - The STOIC Study (STerOids in COVID)

niversity of Oxford, Clinical Trials and Research Governance0 sites478 target enrollmentMay 15, 2020

Overview

No summary available.

Registry

who.int

Start Date

May 15, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Oxford, Clinical Trials and Research Governance

•\-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

•\-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.