COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621001200875.aspx

Prof Michael Dinh

Michael.Dinh@health.nsw.gov.au

2021-09-08

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

- 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

- 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

2

Royal Prince Alfred Hospital

18

100

Australia

Mild disease at enrollment

1: Mild disease at enrollment

650

COVID-19 related hospitalization; defined as COVID-19 related emergency presentation (excluding injuries and presentations for social reasons); or hospital admission or intensive care unit admission or death. Decisions about COVID-19 relatedness will be made after independent review of available data by two clinicians masked to treatment allocation.This data will be collected using data linkage to electronic medical records[For a data collection period until Jan 2022; with data updated weekly until end of the data collection period]

Phase 2

[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]