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 vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.
Drug: Bamlanivimab
Administered intravenously.
Other Name: Array
Inclusion Criteria:
- 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 Criteria:
- 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.
Presbyterian Medical Center
Albuquerque, New Mexico, United States
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director
Eli Lilly and Company