Clareo Health | A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization
Are men or non-pregnant women who agree to contraceptive requirements
Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities
Have venous access sufficient to allow intravenous infusions and blood sampling
The participant or legally authorized representative give signed informed consent
Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening
* Are greater than or equal to (≥) 65 years of age
* Have a body mass index (BMI) ≥ 35
* Have chronic kidney disease
* Have type 1 or type 2 diabetes
* Have immunosuppressive disease
* Are currently receiving immunosuppressive treatment, or
* Are ≥ 55 years of age AND have
* cardiovascular disease, OR
* hypertension, OR
* chronic obstructive pulmonary disease or other chronic respiratory disease
Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic
You may not be if
Parts 1 and 2:
* Recovered from confirmed COVID-19 disease or asymptomatic infection
* Prior history of a positive SARS-CoV-2 serology test
* History of convalescent COVID-19 plasma treatment
* Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine
* Previous receipt of SAR-CoV-2-specific monoclonal antibodies
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
