At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
NCT04656691 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139
Last updated 2022-03-18
Summary
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.
Conditions
- Covid19
Interventions
- DRUG
-
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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Optum, Inc.
collaborator INDUSTRY -
Daniel Griffin
lead INDUSTRY
Principal Investigators
-
Dan Griffin, MD, PHD · ProHealth New York - UnitedHealth Group
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-04
- Primary Completion
- 2021-04-18
- Completion
- 2021-04-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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