Clinical trial NCT04796402: A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19
Official title: A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
Keywords: Bamlanivimab
monoclonal antibody
hospitalization
mortality
COVID-19
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Fraser Health Authrority Department of Evaluation and Research Services
name: Surrey Memorial Hospital Clinical Research Unit
name: Centre for Health Evaluation and Outcome Sciences
name: Surrey Hospital Foundation
name: BC Support Unit
name: University of British Columbia
name: Ministry of Health, British Columbia
name: Clinical Trials BC (part of the BC Academic Health Science Network)
First posted: 2021-03-12
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2.
timeFrame: 0 - 28 days following first positive test for COVID 19
Secondary outcomes:
measure: Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2.
timeFrame: 0 - 28 days following first positive test for COVID-19
measure: Mortality following first positive test for SARS-CoV2.
timeFrame: 28 days, 3 month and 6 months post-treatment
measure: Health-related quality of life assessment.
timeFrame: Screening and 6 months post-treatment
measure: Hospitalization by age and comorbidities.
timeFrame: Treatment day and up to 6 months post-treatment
measure: Incidence and types of adverse reactions including anaphylaxis.
timeFrame: Treatment day and up to 6 months post-treatment
measure: Recruitment rate.
timeFrame: Upto 8 weeks from day of first patient recruited to day of last patient recruited
measure: Overall satisfaction with participation in research.
timeFrame: 6 months post-treatment
measure: Type and frequency of viral variants in patients receiving bamlanivimab.
timeFrame: Up to 8 weeks from day of first patient recruited to day of last patient recruited
Other outcomes:
Locations:
city: Fraser Health Region
country: Canada
facility: Fraser Health Authority
state: British Columbia
Study officials:
References:
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.