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

Covid19 Clinical Trial

— UNITED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04656691
• Other study ID #: 2020-0081_
• Status: Terminated
• Phase: Phase 4
• Start date: January 4, 2021
• Est. completion date: April 18, 2021

Study information

• Verified date: March 2022
• Source: UnitedHealth Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Est. completion date: April 18, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
United States	QueryLab	Minnetonka	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Daniel Griffin	Eli Lilly and Company, Optum, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Days 1-28 after at-home infusion of Bamlanivimab

External Links

•   Eli Lilly SARS-COV-2 Update