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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bamlanivimab
Sponsored by
Daniel Griffin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, bamlanivimab, UnitedHealth

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

  • QueryLab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with COVID-19

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 4, 2020
Last Updated
March 16, 2022
Sponsor
Daniel Griffin
Collaborators
Eli Lilly and Company, Optum, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04656691
Brief Title
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Acronym
UNITED
Official Title
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
In April 2021 FDA revoked the Emergency Use Authorization after determining that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
April 18, 2021 (Actual)
Study Completion Date
April 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Griffin
Collaborators
Eli Lilly and Company, Optum, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID19, bamlanivimab, UnitedHealth

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Participants with COVID-19
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
bamlanivimab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28
Description
Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise
Time Frame
Days 1-28 after at-home infusion of Bamlanivimab
Secondary Outcome Measure Information:
Title
Safety - Documenting Adverse Events After Infusion
Description
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.
Time Frame
Days 1-28 after at-home infusion of Bamlanivimab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Griffin, MD, PHD
Organizational Affiliation
ProHealth New York - UnitedHealth Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
QueryLab
City
Minnetonka
State/Province
Minnesota
ZIP/Postal Code
55343
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share participant level data with other projects or researchers.
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
Links:
URL
https://investor.lilly.com/news-releases/news-release-details/lilly-provides-comprehensive-update-progress-sars-cov-2
Description
Eli Lilly SARS-COV-2 Update
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://investor.lilly.com/news-releases/news-release-details/lilly-provides-comprehensive-update-progress-sars-cov-2

Learn more about this trial

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

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