Status:
COMPLETED
A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
AbCellera Biologics Inc.
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a...
Eligibility Criteria
Inclusion
- Are currently not hospitalized.
- Have one or more mild or moderate COVID-19 symptoms.
- Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset
- Are males or non-breastfeeding females.
- Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.
- Are at high risk for progressing to severe COVID-19 and/or hospitalization.
Exclusion
- Participants who:
- are hospitalized due to COVID-19, OR
- require oxygen therapy due to COVID-19, OR
- 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.
- Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (\<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.
- Have body weight \<40 kilograms.
- Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Have known allergies to any of the components used in the formulation of the interventions.
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
- Have any comorbidity requiring surgery within \<7 days, or that is considered life-threatening within 29 days.
- Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- Have a history of a positive SARS-CoV-2 serology test.
- Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
- Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19.
- Have received convalescent COVID-19 plasma treatment.
- Have participated in a previous SARS-CoV-2 vaccine study.
- Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Are breast-feeding.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04701658
Start Date
February 1 2021
End Date
June 22 2021
Last Update
November 16 2021
Active Locations (1)
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1
Presbyterian Medical Center
Albuquerque, New Mexico, United States, 87110