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

Phase 4

Terminated

• Conditions: Covid19
• Interventions: Drug: bamlanivimab

• Registration Number: NCT04656691
• Lead Sponsor: Daniel Griffin

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-07
• Study Start: 2021-01-04
• Primary Completion: 2021-04-18
• Study Completion: 2021-04-18
• Status Verified: 2022-03
• Results First Submitted: 2022-03-03
• Results First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Results First Posted: 2022-03-18
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with COVID-19	bamlanivimab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28	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

Name	Time	Method
Safety - Documenting Adverse Events After Infusion	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.

Trial Locations

Locations (1)

QueryLab; 🇺🇸 Minnetonka, Minnesota, United States