A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19 (B-EPIC)
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Bamlanivimab, monoclonal antibody, hospitalization, mortality, COVID-19
Eligibility Criteria
Inclusion Criteria:
Age at the time of SARS-CoV2 test:
- Age > 65
- Age 55-64 and 1 or more of:
i. BMI>35, ii. chronic kidney disease, iii. diabetes mellitus, iv. immunosuppressive disease v. current immunosuppressive treatment vi. hypertension vii. coronary artery disease viii. chronic lung disease
c. Age 18-54 and 1 or more of: i. BMI>35 ii. chronic kidney disease iii. diabetes mellitus iv. immunosuppressive disease v. current immunosuppressive treatment
Disease Characteristics:
- Not hospitalized
- Sample collection for first SARS-CoV2 test positive within 3 days prior to consent.
- One or more mild COVID-19 symptoms and within 10 days from onset
i. Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms viii. Shortness of breath with/without exertion
Study Procedures:
- Resident of British Columbia
- Understand and agree to planned study procedures
- Ability and Willingness to Provide Informed Consent:
The participant will provide informed consent by telephone
Exclusion Criteria:
Medical Conditions
- Allergies to any of the components used in the formulation of the bamlanivimab
- Hospitalization or expected to need hospitalization in the next 24 hours at the time of recruitment for COVID-19
- Suspected or proven infection other than COVID-19 that in the opinion of the clinicians could pose a risk to study inclusion
- Any co-morbidity considered life-threatening in <28 days, or requiring surgery in <7 days.
- Any serious disease, condition or disorder that in the opinion of the clinicians should preclude participation.
- Require oxygen therapy due to COVID-19
- Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- Weighs < 40 kg
- History of vaccination against SARS-CoV2
- History of convalescent plasma or IVIG therapy within 3 months of first SARS-CoV2 viral determination positive
- History of previous SARS-CoV2 infection
- History of participation in any clinical study involving an investigational intervention within 30 days or 5 half-lives of the previous intervention, whichever is longer.
- Unable to achieve informed consent for any reason
- Known Pregnancy
- Actively breast-feeding.
Sites / Locations
- Fraser Health Authority
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
Intervention
Standard of care
Administration of Bamlanivimab