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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2021-04-18

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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with COVID-19

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.

Group Type EXPERIMENTAL

bamlanivimab

Intervention Type DRUG

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.

Interventions

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bamlanivimab

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.

Intervention Type DRUG

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes