A randomised controlled trial of Dexamethasone for Emergency and Life-Threatening Admissions due to COVID-19 in Virtual Care: the DELTA study

Phase 2

Recruiting

• Conditions: COVID-19 Delta Variant; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases; Emergency medicine - Other emergency care

• Registration Number: ACTRN12621001200875
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-08
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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]