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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04656691
Status
Terminated
Sponsor
Daniel Griffin

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.