None listed
Conditions
Brief summary
The aim of this study is to accelerate the implementation of treatments to reduce the burden of morbidity and mortality due to severe respiratory disease in people with COVID-19. Who is it for? You may be eligible to join this study if you have a confirmed diagnosis of COVID-19, are aged 18 years or more, and do not have clinical features of severe respiratory disease or require inpatient care. Study details Participants in this study will be randomly allocated (by chance) to a treatment group. Treatments will be added during the course of the trial and will only commence once necessary approvals have been obtained. All participants will be monitored for various events, such as hospital admission, ICU admission, mechanical ventilation, fever, symptoms and adverse events. It is hoped that this study will accelerate the acquisition of evidence about the effectiveness and safety of proposed new treatments, ensure patients with COVID-19 receive the optimal treatment for their condition based on the best current evidence at the time they are being treated, and ensure rapid implementation of new treatments
Interventions
Bayesian adaptive randomisation and analysis methodology will accelerate the acquisition of evidence about the effectiveness and safety of proposed new treatments ensure rapid implementation of new treatments.
Study treatments or interventions will be added to the trial as a protocol treatment appendix after identification by study investigators and then recommendation by the BEAT COVID-19 Candidate Intervention Expert Committee based on safety, biological plausibility and/or efficacy data. Tre
Bayesian adaptive randomisation and analysis methodology will accelerate the acquisition of evidence about the effectiveness and safety of proposed new treatments ensure rapid implementation of new treatments. Study treatments or interventions will be added to the trial as a protocol treatment appendix after identification by study investigators and then recommendation by the BEAT COVID-19 Candidate Intervention Expert Committee based on safety, biological plausibility and/or efficacy data. Treatments currently include Ciclesonide. The Ciclesonide domain includes inhaled ciclesonide 320mcg daily for 14 days compared to placebo. Adherence to the intervention will be monitored via a daily participant diary for 28 days post randomisation and follow up calls from the study team. The treatment or intervention will commence once all necessary approvals are obtained.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, aged greater than or equal to 18 years. 2. PCR or RAT-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. 3. Intention for community-based management. 4. Eligibility to at least one recruiting domain. 5. Participant & treating clinician are willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments, and. 6. Documented informed consent
Exclusion criteria
1. Currently pregnant or breast-feeding 2. Any medical condition which, in the opinion of the Investigator, may affect the participant’s safety or study participation and conduct
Outcome results
None listed