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

NCT04796402 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: FHREB 2021-023
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of care

Other: Standard of Care

Intervention

EXPERIMENTAL

Administration of Bamlanivimab

Biological: Bamlanivimab

Interventions

Bamlanivimab BIOLOGICAL

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

Intervention

Standard of Care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fraser Health Authority

Fraser Health Region, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimab; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: March 17, 2021
• Primary Completion: June 7, 2021
• Study Completion: December 31, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

CA (1)