None listed
Conditions
Brief summary
The DELTA study is a double blinded parallel arm randomised controlled trial designed to test the hypothesis that a two-day course of oral dexamethasone in mild to moderate COVID-19 patients results in fewer COVID-19 related hospitalisations, intensive care unit admissions and death; and reduced time to self-reported symptom resolution. Once patients have consented to participate in the study, they will be randomised to receive either 6mg oral dexamethasone or 150mg thiamine (placebo). Study information will be collected from electronic Medical Records (eMR). Only routinely collected data will be used for this study, and will include disposition, intensive care admission, ventilation days and total hospital length of stay. Data managers and/or clinical nurse consultants will assist with data extraction. Data will be collected and entered into SLHD RedCap. Data analysis will follow.
Interventions
Usual care as per local hospital protocols for COVID-19 plus oral dexamethasone. Those receiving oral dexamethasone will be required to take 6mg orally per day for 2 days. We will contact the patient daily to assess for study drug adherence.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult patients (age greater than or equal to 18 years) - Currently under the care of RPAV in the community or Special Health Accommodation (SHA) - Confirmed COVID-19 on Polymerase Chain Reaction (PCR) testing within the last 14 days - Exhibiting mild/moderate COVID-19 symptoms (fever, respiratory tract symptoms, chest pain, lethargy, dizziness, myalgia, anosmia, dyspnea, headache, gastrointestinal symptoms), with no requirement for oxygen or hospitalization - Requiring nursing or medical assessment by RPA Virtual Hospital clinicians within 72 hours for new or escalating symptoms of mild to moderate COVID-19
Exclusion criteria
- Currently taking oral or inhaled corticosteroids - Major medical or psychiatric comorbidities precluding the use of corticosteroids (e.g. poorly controlled diabetes mellitus, chronic heart disease, chronic renal disease, chronic liver failure, schizophrenia or thought disorder, bipolar disorder) - Immunosuppression or treatment for malignancy - Hypersensitivity to corticosteroids, thiamine, wheat, lactose, povidone, maize starch or magnesium stearate - History of alcohol dependence or at risk alcohol intake - At risk for thiamine deficiency (e.g. eating disorders, chronic malabsorption) - Requires urgent transfer to the emergency department at the time of assessment - Patient declines or is unable to provide consent - Lactating or pregnant women - No access to a personal or loaned electronic device, - Unable to read or write English
Outcome results
None listed