NCT04796402

A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19

A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Fraser Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to test whether a new medication called bamlanivimab is safe and effective at reducing the need for hospitalization due to COVID-19.

Detailed description

The study aims to examine the effectiveness of adding bamlanivimab provided by COVID-19 Clinics to standard of care on the incidence of hospitalization for high-risk patients infected with SARS-CoV2. Furthermore, we aim to test the effect on the following secondary outcomes: mortality and health-related quality of life and patients' satisfaction with care. We will also assess the recruitment rate from the three primary strategies for rapid identification and consent of eligible patients. The data from this study will inform clinical decisions about the use of bamlanivimab in high risk COVID-19 patients and the operational requirements necessary for research in passive immunity therapeutics.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Bamlanivimab	700 mg/20mL IV over at least one hour OD
OTHER	Standard of Care	Standard of care includes primary care and specialist care as indicated by the patient's primary care provider

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-06-07
• Completion: 2021-12-31
• First posted: 2021-03-12
• Last updated: 2021-08-26

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study