At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19

Study Overview
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Brief Summary
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This is an open-label, pragmatic, single-dose study using matched controls in participants with mild to moderate COVID-19. Participants will track for developing symptoms while at home and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants will then track for 28 days to assess for any additional medical care needed or if hospitalization was required.

Official Title
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At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: bamlanivimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UnitedHealthcare member confirmed COVID-19 positive located in an area where Bamlanivimab (LY3819253) is available for infusion Exclusion Criteria: current (from first symptom report) hospitalization for COVID-19 prior administration of Bamlanivimab or other COVID-19 therapies previous COVID-19 diagnosis prior receipt of a COVID-19 vaccine not authorized for patient use per the EUA

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with COVID-19<br>Participants testing positive for COVID-19 may be eligible to receive a one-time dose of bamlanivimab 700 mg, delivered via infusion through the vein, lasting around 60 minutes. This infusion will be done in-home and administered by a registered nurse. | Drug: bamlanivimab<br>* Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28 | Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise | Days 1-28 after at-home infusion of Bamlanivimab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Documenting Adverse Events After Infusion | Describe the incidence of infusion reactions recorded by the Optum Infusion nurse on the Case Report Form (CRF) during receipt of infusion and during the defined infusion follow-up period. The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. | Days 1-28 after at-home infusion of Bamlanivimab | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, bamlanivimab, UnitedHealth