Status:
UNKNOWN
A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19
Lead Sponsor:
Fraser Health
Collaborating Sponsors:
Fraser Health Authrority Department of Evaluation and Research Services
Surrey Memorial Hospital Clinical Research Unit
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Suspected or proven infection other than COVID-19 that in the opinion of the clinicians could pose a risk to study inclusion
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT04796402
Start Date
March 17 2021
End Date
December 31 2021
Last Update
August 26 2021
Active Locations (1)
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1
Fraser Health Authority
Fraser Health Region, British Columbia, Canada