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

NCT ID: NCT04796402

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2021-12-31

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard of care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Intervention

Administration of Bamlanivimab

Group Type: EXPERIMENTAL

Bamlanivimab

Intervention Type: BIOLOGICAL

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

Interventions

Bamlanivimab

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

Intervention Type: BIOLOGICAL

Standard of Care

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fraser Health Authrority Department of Evaluation and Research Services

UNKNOWN

Sponsor Role: collaborator

Surrey Memorial Hospital Clinical Research Unit

UNKNOWN

Sponsor Role: collaborator

Centre for Health Evaluation and Outcome Sciences

UNKNOWN

Sponsor Role: collaborator

Surrey Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

BC Support Unit

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Ministry of Health, British Columbia

OTHER_GOV

Sponsor Role: collaborator

Clinical Trials BC (part of the BC Academic Health Science Network)

UNKNOWN

Sponsor Role: collaborator

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Gregory Haljan, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fraser Health Authority

Fraser Health Region, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Other Identifiers

FHREB 2021-023

Identifier Type: -

Identifier Source: org_study_id