A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Bamlanivimab
Intervention description: Administered intravenously.
Intervention MeSH terms: Bamlanivimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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.