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

NCT04656691 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2020-0081_
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID19; bamlanivimab; UnitedHealth

Outcome Measures

Primary Outcomes (1)

• 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

  Days 1-28 after at-home infusion of Bamlanivimab

Secondary Outcomes (1)

• Safety - Documenting Adverse Events After Infusion

  Days 1-28 after at-home infusion of Bamlanivimab

Study Arms (1)

Participants with COVID-19

EXPERIMENTAL

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

Interventions

bamlanivimab DRUG

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.

Participants with COVID-19

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• UnitedHealthcare member
• confirmed COVID-19 positive
• located in an area where Bamlanivimab (LY3819253) is available for infusion

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Griffin: lead
• Eli Lilly and Company: collaborator
• Optum, Inc.: collaborator

Study Sites (1)

QueryLab

Minnetonka, Minnesota, 55343, United States

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Tracy Ziolek , Vice President, Human Research Affairs
• Organization: UnitedHealth Group/Optum Labs

tracy_ziolek@uhg.com

215-868-3114

Study Officials

• Dan Griffin, MD, PHD

  ProHealth New York - UnitedHealth Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Daniel Griffin, MD PhD CTropMed CTH

Model Details: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 7, 2020
• Study Start: January 4, 2021
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)