Covid19
Conditions
Keywords
Bamlanivimab, monoclonal antibody, hospitalization, mortality, COVID-19
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.
Interventions
BIOLOGICALBamlanivimab
700 mg/20mL IV over at least one hour OD
OTHERStandard of Care
Standard of care includes primary care and specialist care as indicated by the patient's primary care provider
Sponsors
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)
Fraser Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20) |
| Hospitalization by age and comorbidities. | Treatment day and up to 6 months post-treatment | — |
| 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 | — |
| Recruitment rate. | Upto 8 weeks from day of first patient recruited to day of last patient recruited | — |
| Overall satisfaction with participation in research. | 6 months post-treatment | Likert Scale |
| 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 | — |
| Incidence and types of adverse reactions including anaphylaxis. | Treatment day and up to 6 months post-treatment | — |
Countries
Canada
Outcome results
None listed