A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (BLAZE-5)

Lilly

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Bamlanivimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04701658

J2X-MC-PYAJ (Other Identifier)

18216

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Bamlanivimab

Experimental group

Description:

Participants received 700 milligram single intravenous infusion of Bamlanivimab.

Treatment:

Drug: Bamlanivimab

Controls

No Intervention group

Description:

Matched controls who received standard of care. \[The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.\]