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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656691
Recruitment Status : Terminated (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.)
First Posted : December 7, 2020
Results First Posted : March 18, 2022
Last Update Posted : March 18, 2022
Sponsor:
Collaborators:
Eli Lilly and Company
Optum, Inc.
Information provided by (Responsible Party):
Daniel Griffin, UnitedHealth Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: bamlanivimab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Actual Study Start Date : January 4, 2021
Actual Primary Completion Date : April 18, 2021
Actual Study Completion Date : April 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28 [ Time Frame: Days 1-28 after at-home infusion of Bamlanivimab ]
    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 :
  1. Safety - Documenting Adverse Events After Infusion [ Time Frame: Days 1-28 after at-home infusion of Bamlanivimab ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656691


Locations
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United States, Minnesota
QueryLab
Minnetonka, Minnesota, United States, 55343
Sponsors and Collaborators
Daniel Griffin
Eli Lilly and Company
Optum, Inc.
Investigators
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Principal Investigator: Dan Griffin, MD, PHD ProHealth New York - UnitedHealth Group
  Study Documents (Full-Text)

Documents provided by Daniel Griffin, UnitedHealth Group:
Study Protocol  [PDF] February 3, 2021
Statistical Analysis Plan  [PDF] March 9, 2021

More Information
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Additional Information:

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel Griffin, Daniel Griffin, MD PhD CTropMed CTH, UnitedHealth Group
ClinicalTrials.gov Identifier: NCT04656691    
Other Study ID Numbers: 2020-0081_
First Posted: December 7, 2020    Key Record Dates
Results First Posted: March 18, 2022
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share participant level data with other projects or researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Griffin, UnitedHealth Group:
COVID19
bamlanivimab
UnitedHealth
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bamlanivimab
Antiviral Agents
Anti-Infective Agents