A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bamlanivimab 		Participants received 700 milligram single intravenous infusion of Bamlanivimab.
  • Drug: Bamlanivimab
    Administered intravenously.
    Other names:
    • LY3819253
    • LY-CoV555
No Intervention
Controls 		Matched controls who received standard of care. [The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.]

Recruiting Locations

More Details

NCT ID
NCT04701658
Status
Completed
Sponsor
Eli Lilly and Company