Phase 3
Completed N=1,180
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
COVID · SARS-CoV2
Source: ClinicalTrials.gov NCT04497987 ↗
Enrolled (actual)
1,180
Serious AEs
5.9%
Results posted
Feb 2022
Primary outcomePrimary: Percentage of Participants With COVID-19 — 15.7; 8.3 Percentage of Participants — p=<0.001
◆ Published Evidence
Highly cited
208citations · ~42 / year
Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial.
Summary
The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.
Linked Publications (4)
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Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial.
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SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
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SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.
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A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With COVID-19 |
15.7; 8.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Moderate or Worse Severity COVID-19 |
14.7; 8.1 | <0.001 sig |
| SECONDARY Percentage of Participants With SARS-CoV-2 |
23.1; 17.8 | 0.021 sig |
| SECONDARY Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 |
1.4; 0.4 | — |
| SECONDARY Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death |
1.4; 0.6 | — |
| SECONDARY Percentage of Participants Who Die Due to COVID-19 |
0.8; 0 | — |
| SECONDARY Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone |
162; 61.8; 28.4; 17.5; 15.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04497987) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.