A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19 (B-EPIC)

Fraser Health

Status and phase

Unknown

Phase 4

Conditions

Covid19

Treatments

Other: Standard of Care

Biological: Bamlanivimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04796402

FHREB 2021-023

Details and patient eligibility

About

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.

Full description

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.

Enrollment

576 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age at the time of SARS-CoV2 test:
1. Age > 65
2. 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:
1. Not hospitalized
2. Sample collection for first SARS-CoV2 test positive within 3 days prior to consent.
3. 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:
1. Resident of British Columbia
2. 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
1. Allergies to any of the components used in the formulation of the bamlanivimab
2. Hospitalization or expected to need hospitalization in the next 24 hours at the time of recruitment for COVID-19
3. Suspected or proven infection other than COVID-19 that in the opinion of the clinicians could pose a risk to study inclusion
4. Any co-morbidity considered life-threatening in <28 days, or requiring surgery in <7 days.
5. Any serious disease, condition or disorder that in the opinion of the clinicians should preclude participation.
6. Require oxygen therapy due to COVID-19
7. 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.