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| Name | Class |
|---|---|
| Fraser Health Authrority Department of Evaluation and Research Services | UNKNOWN |
| Surrey Memorial Hospital Clinical Research Unit | UNKNOWN |
| Centre for Health Evaluation and Outcome Sciences | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard of care |
|
| Intervention | Experimental | Administration of Bamlanivimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bamlanivimab | Biological | 700 mg/20mL IV over at least one hour OD |
| |
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Age at the time of SARS-CoV2 test:
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:
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:
Ability and Willingness to Provide Informed Consent:
The participant will provide informed consent by telephone
Exclusion Criteria:
Medical Conditions
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraser Health Authority | Fraser Health Region | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711749 | bamlanivimab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Surrey Hospital Foundation | UNKNOWN |
| BC Support Unit | OTHER |
| University of British Columbia | OTHER |
| Ministry of Health, British Columbia | OTHER_GOV |
| Clinical Trials BC (part of the BC Academic Health Science Network) | UNKNOWN |
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| Standard of Care |
| Other |
Standard of care includes primary care and specialist care as indicated by the patient's primary care provider |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |