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Trial record 2 of 2 for:    B-EPIC

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

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ClinicalTrials.gov Identifier: NCT04796402
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : April 9, 2021
Sponsor:
Collaborators:
Fraser Health Authrority Department of Evaluation and Research Services
Surrey Memorial Hospital Clinical Research Unit
Centre for Health Evaluation and Outcome Sciences
Surrey Hospital Foundation
BC Support Unit
University of British Columbia
Ministry of Health, British Columbia
Clinical Trials BC (part of the BC Academic Health Science Network)
Information provided by (Responsible Party):
Gregory Haljan, MD, Fraser Health

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 17, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Mortality following first positive test for SARS-CoV2. [ Time Frame: 28 days, 3 month and 6 months post-treatment ]
  3. Health-related quality of life assessment. [ Time Frame: Screening and 6 months post-treatment ]
    Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)

  4. Hospitalization by age and comorbidities. [ Time Frame: Treatment day and up to 6 months post-treatment ]
  5. Incidence and types of adverse reactions including anaphylaxis. [ Time Frame: Treatment day and up to 6 months post-treatment ]
  6. Recruitment rate. [ Time Frame: Upto 8 weeks from day of first patient recruited to day of last patient recruited ]
  7. Overall satisfaction with participation in research. [ Time Frame: 6 months post-treatment ]
    Likert Scale

  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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

  2. 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

  3. Study Procedures:

    1. Resident of British Columbia
    2. Understand and agree to planned study procedures
  4. Ability and Willingness to Provide Informed Consent:

The participant will provide informed consent by telephone

Exclusion Criteria:

  1. 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.
  2. Weighs < 40 kg
  3. History of vaccination against SARS-CoV2
  4. History of convalescent plasma or IVIG therapy within 3 months of first SARS-CoV2 viral determination positive
  5. History of previous SARS-CoV2 infection
  6. 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.
  7. Unable to achieve informed consent for any reason
  8. Known Pregnancy
  9. Actively breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796402


Locations
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Canada, British Columbia
Fraser Health Authority Recruiting
Fraser Health Region, British Columbia, Canada
Contact: B-Epic Study    +1 236 332 9517    b-epicstudy@fraserhealth.ca   
Sponsors and Collaborators
Fraser Health
Fraser Health Authrority Department of Evaluation and Research Services
Surrey Memorial Hospital Clinical Research Unit
Centre for Health Evaluation and Outcome Sciences
Surrey Hospital Foundation
BC Support Unit
University of British Columbia
Ministry of Health, British Columbia
Clinical Trials BC (part of the BC Academic Health Science Network)
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Responsible Party: Gregory Haljan, MD, Principal Investigator, Fraser Health
ClinicalTrials.gov Identifier: NCT04796402    
Other Study ID Numbers: FHREB 2021-023
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gregory Haljan, MD, Fraser Health:
Bamlanivimab
monoclonal antibody
hospitalization
mortality
COVID-19