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

Sponsor

Fraser Health (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04796402

Collaborator

Fraser Health Authrority Department of Evaluation and Research Services (Other), Surrey Memorial Hospital Clinical Research Unit (Other), Centre for Health Evaluation and Outcome Sciences (Other), Surrey Hospital Foundation (Other), BC Support Unit (Other), University of British Columbia (Other), Ministry of Health, British Columbia (Other), Clinical Trials BC (part of the BC Academic Health Science Network) (Other)

576

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

60.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: Bamlanivimab Other: Standard of Care	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

576 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19

Actual Study Start Date :

Mar 17, 2021

Actual Primary Completion Date :

Jun 7, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Standard of care	Other: Standard of Care Standard of care includes primary care and specialist care as indicated by the patient's primary care provider
Experimental: Intervention Administration of Bamlanivimab	Biological: Bamlanivimab 700 mg/20mL IV over at least one hour OD

Arm

Intervention/Treatment

Active Comparator: Control

Standard of care

Other: Standard of Care

Standard of care includes primary care and specialist care as indicated by the patient's primary care provider

Experimental: Intervention

Administration of Bamlanivimab

Biological: Bamlanivimab

700 mg/20mL IV over at least one hour OD

Outcome Measures

Primary Outcome Measures

Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2. [0 - 28 days following first positive test for COVID 19]

Secondary Outcome Measures

Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2. [0 - 28 days following first positive test for COVID-19]
Mortality following first positive test for SARS-CoV2. [28 days, 3 month and 6 months post-treatment]
Health-related quality of life assessment. [Screening and 6 months post-treatment]
Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)
Hospitalization by age and comorbidities. [Treatment day and up to 6 months post-treatment]
Incidence and types of adverse reactions including anaphylaxis. [Treatment day and up to 6 months post-treatment]
Recruitment rate. [Upto 8 weeks from day of first patient recruited to day of last patient recruited]
Overall satisfaction with participation in research. [6 months post-treatment]
Likert Scale
Type and frequency of viral variants in patients receiving bamlanivimab. [Up to 8 weeks from day of first patient recruited to day of last patient recruited]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age at the time of SARS-CoV2 test:
Age > 65
Age 55-64 and 1 or more of:

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
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

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.