The purpose of this research is to test whether a new medication called bamlanivimab is safe and effective at reducing the need for hospitalization due to COVID-19.
The study aims to examine the effectiveness of adding bamlanivimab provided by COVID-19 Clinics to standard of care on the incidence of hospitalization for high-risk patients infected with SARS-CoV2. Furthermore, we aim to test the effect on the following secondary outcomes: mortality and health-related quality of life and patients' satisfaction with care. We will also assess the recruitment rate from the three primary strategies for rapid identification and consent of eligible patients. The data from this study will inform clinical decisions about the use of bamlanivimab in high risk COVID-19 patients and the operational requirements necessary for research in passive immunity therapeutics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
576
700 mg/20mL IV over at least one hour OD
Standard of care includes primary care and specialist care as indicated by the patient's primary care provider
Fraser Health Authority
Fraser Health Region, British Columbia, Canada
Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2.
Time frame: 0 - 28 days following first positive test for COVID 19
Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2.
Time frame: 0 - 28 days following first positive test for COVID-19
Mortality following first positive test for SARS-CoV2.
Time frame: 28 days, 3 month and 6 months post-treatment
Health-related quality of life assessment.
Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)
Time frame: Screening and 6 months post-treatment
Hospitalization by age and comorbidities.
Time frame: Treatment day and up to 6 months post-treatment
Incidence and types of adverse reactions including anaphylaxis.
Time frame: Treatment day and up to 6 months post-treatment
Recruitment rate.
Time frame: Upto 8 weeks from day of first patient recruited to day of last patient recruited
Overall satisfaction with participation in research.
Likert Scale
Time frame: 6 months post-treatment
Type and frequency of viral variants in patients receiving bamlanivimab.
Time frame: Up to 8 weeks from day of first patient recruited to day of last patient recruited
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