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

UnitedHealth Group

Status and phase: Terminated; Phase 4

Conditions: Covid19

Treatments: Drug: bamlanivimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04656691

2020-0081_

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

Participants with COVID-19

Experimental group

Description:

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.

Treatment:

Drug: bamlanivimab