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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Standard of Care; Biological: Bamlanivimab

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 Type: Interventional
• Enrollment (Anticipated): 576
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Fraser Health Region, British Columbia, Canada
      • Fraser Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.	Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)	Screening and 6 months post-treatment
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.	Likert Scale	6 months post-treatment
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): June 7, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; monoclonal antibody; mortality; hospitalization; Bamlanivimab
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Bamlanivimab
• Other Study ID Numbers: FHREB 2021-023

Drug and device information, study documents

• 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