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: Not yet recruiting

Administrative data

• NCT number: NCT04639479
• Other study ID #: 2020-0081
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2020
• Est. completion date: May 2021

Study information

• Verified date: November 2020
• Source: UnitedHealth Group
• Contact: Michelle Tanner, BA
• Phone: 952-219-4070
• Email: michelle_tanner[@]uhg.com
• 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. Potential 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: Not yet recruiting
• Enrollment: 7500
• Est. completion date: May 2021
• Est. primary completion date: May 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

• 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
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - determining hospitalization rates	Determine the incidence of COVID-19 related hospitalization at day 28 among treated-participants relative to external controls.; Long-term: hospitalization rate via medical records/claims data Short-term: participants self-report during active study participation	28 days after infusion date
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.	28 days after infusion date

External Links

•   Eli Lilly SARS-COV-2 Update