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

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Bamlanivimab

Standard of Care

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Bamlanivimab, monoclonal antibody, hospitalization, mortality, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Fraser Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Standard of care

Administration of Bamlanivimab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2.

Mortality following first positive test for SARS-CoV2.

Health-related quality of life assessment.

Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)

Hospitalization by age and comorbidities.

Incidence and types of adverse reactions including anaphylaxis.

Recruitment rate.

Overall satisfaction with participation in research.

Likert Scale

Type and frequency of viral variants in patients receiving bamlanivimab.

Full Information

NCT ID

NCT04796402

First Posted

March 10, 2021

Last Updated

August 24, 2021

Sponsor

Fraser Health

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)

1. Study Identification

Unique Protocol Identification Number

NCT04796402

Brief Title

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

Acronym

B-EPIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 17, 2021 (Actual)

Primary Completion Date

June 7, 2021 (Actual)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fraser Health

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Bamlanivimab, monoclonal antibody, hospitalization, mortality, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

576 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Standard of care

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Administration of Bamlanivimab

Intervention Type

Biological

Intervention Name(s)

Bamlanivimab

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

Mortality following first positive test for SARS-CoV2.

Time Frame

28 days, 3 month and 6 months post-treatment

Title

Health-related quality of life assessment.

Description

Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)

Time Frame

Screening and 6 months post-treatment

Title

Hospitalization by age and comorbidities.

Time Frame

Treatment day and up to 6 months post-treatment

Title

Incidence and types of adverse reactions including anaphylaxis.

Time Frame

Treatment day and up to 6 months post-treatment

Title

Recruitment rate.

Time Frame

Upto 8 weeks from day of first patient recruited to day of last patient recruited

Title

Overall satisfaction with participation in research.

Description

Likert Scale

Time Frame

6 months post-treatment

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Fraser Health Authority

City

Fraser Health Region

State/Province

British Columbia

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34473343

Citation

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.

Results Reference

derived

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

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