Trial · NCT04497987
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
NCT04497987, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04497987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04497987
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04497987
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,180 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- COVID-19, SARS-CoV2
- Interventions
- Bamlanivimab, Placebo, Etesevimab
- First posted
- 2020-08-04
- Last updated
- 2022-02-04
- Results first posted
- 2022-02-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With COVID-19 | Week 8 after randomization | The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables. |
| Secondary | Percentage of Participants With Moderate or Worse Severity COVID-19 | Week 8 after randomization | The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables. |
| Secondary | Percentage of Participants With SARS-CoV-2 | Week 4 | Percentage of Participants with SARS-CoV-2. |
| Secondary | Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 | Week 8 | Percentage of Participants Who are Hospitalized or Have Died due to COVID-19. |
| Secondary | Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death | Week 8 | Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death. |
| Secondary | Percentage of Participants Who Die Due to COVID-19 | Week 8 | Percentage of Participants Who Die Due to COVID-19. |
| Secondary | Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone | Day 29, 57, 85, 141 and 169 | Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With COVID-19 | Week 8 after randomization | All randomized participants from prevention population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Moderate or Worse Severity COVID-19 | Week 8 after randomization | All randomized participants from prevention population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With SARS-CoV-2 | Week 4 | All randomized participants from prevention population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 | Week 8 | All randomized participants from prevention population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death | Week 8 | All randomized participants from prevention population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Die Due to COVID-19 | Week 8 | All randomized participants from prevention population. | Percentage of Participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone | Day 29, 57, 85, 141 and 169 | All randomized participants who received at least one dose of bamlanivimab and had evaluable PK data. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With COVID-19 | Placebo | 15.7 | 95% Confidence Interval 12.5 to 18.9 | Percentage of Participants | |
| Percentage of Participants With COVID-19 | 4200mg Bamlanivimab | 8.3 | 95% Confidence Interval 5.8 to 10.7 | Percentage of Participants | |
| Percentage of Participants With Moderate or Worse Severity COVID-19 | Placebo | 14.7 | 95% Confidence Interval 11.5 to 17.8 | Percentage of Participants | |
| Percentage of Participants With Moderate or Worse Severity COVID-19 | 4200mg Bamlanivimab | 8.1 | 95% Confidence Interval 5.6 to 10.5 | Percentage of Participants | |
| Percentage of Participants With SARS-CoV-2 | Placebo | 23.1 | 95% Confidence Interval 19.4 to 26.9 | Percentage of Participants | |
| Percentage of Participants With SARS-CoV-2 | 4200mg Bamlanivimab | 17.8 | 95% Confidence Interval 14.4 to 21.2 | Percentage of Participants | |
| Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 | Placebo | 1.4 | 95% Confidence Interval 0.4 to 2.5 | Percentage of Participants | |
| Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19 | 4200mg Bamlanivimab | 0.4 | 95% Confidence Interval 0 to 1.0 | Percentage of Participants | |
| Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death | Placebo | 1.4 | 95% Confidence Interval 0.4 to 2.5 | Percentage of Participants | |
| Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death | 4200mg Bamlanivimab | 0.6 | 95% Confidence Interval 0 to 1.3 | Percentage of Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 592 | |
| Overall Study | STARTED | 4200 mg Bamlanivimab | 588 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 587 | |
| Overall Study | Received at Least One Dose of Study Drug | 4200 mg Bamlanivimab | 588 | |
| Overall Study | Prevention Population | Placebo | 485 | |
| Overall Study | Prevention Population | 4200 mg Bamlanivimab | 487 | |
| Overall Study | Treatment Population | Placebo | 68 | |
| Overall Study | Treatment Population | 4200 mg Bamlanivimab | 66 | |
| Overall Study | Serology Positive | Placebo | 36 | |
| Overall Study | Serology Positive | 4200 mg Bamlanivimab | 35 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events680
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 587 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | 4200mg Bamlanivimab | 1 | 588 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 1 | 587 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | 4200mg Bamlanivimab | 0 | 588 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 2 | 587 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 4200mg Bamlanivimab | 0 | 588 | 0 |
| other | Angina pectoris | Cardiac disorders | Placebo | 0 | 587 | 0 |
| other | Angina pectoris | Cardiac disorders | 4200mg Bamlanivimab | 1 | 588 | 1 |
| other | Atrial thrombosis | Cardiac disorders | Placebo | 0 | 587 | 0 |
| other | Atrial thrombosis | Cardiac disorders | 4200mg Bamlanivimab | 1 | 588 | 1 |
1 to 10 of 680Source ClinicalTrials.gov
See all 680 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 21 | 587 |
| Total, all-cause mortality | 4200mg Bamlanivimab | 13 | 588 |
| Total, other adverse events | Placebo | 147 | 587 |
| Total, other adverse events | 4200mg Bamlanivimab | 145 | 588 |
| Total, serious adverse events | Placebo | 30 | 587 |
| Total, serious adverse events | 4200mg Bamlanivimab | 39 | 588 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 4200mg Bamlanivimab vs Placebo: deaths from any cause | Trial comparisons |
| 4200mg Bamlanivimab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04497987
GET https://conductscience.org/api/trials/v1/NCT04497987/events?page=2