a real world study of bamlanivimab in participants with mild-to-moderate coronavirus disease 2019 (covid-19)

Conditions: COVID-19

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 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.


Eligibility criteria:
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.