Trial · NCT04427501

A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

NCT04427501, Phase 2, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-03-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness. Trials, record NCT04427501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04427501

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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 Participants With Mild to Moderate COVID-19 Illness
NCT number: NCT04427501
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 3,307 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: COVID-19
Interventions: LY3819253, LY3832479, LY3853113, Placebo
First posted: 2020-06-11
Last updated: 2024-04-11
Results first posted: 2022-03-07

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups	Baseline through Day 29	COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Primary	Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo	Day 7	SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load \>=5.27 vs otherwise.
Primary	Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Baseline, Day 11	SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.
Primary	Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)	Baseline through Day 85	An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Primary	Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)	Day 29 Post-dose	Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Primary	Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)	Day 29 Post-dose	Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Primary	Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]	Day 60 Post-dose	AUC0-∞ for Bebtelovimab was reported.
Secondary	Phase 3: Percentage of Participants Demonstrating Symptom Resolution	Day 11	Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Secondary	Phase 3: Percentage of Participants Demonstrating Symptom Improvement	Day 11	Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Secondary	Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause	Baseline through Day 85	COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups	Baseline through Day 29	Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.	percentage of participants	NUMBER
PRIMARY	Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo	Day 7	Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab	percentage of participants	NUMBER
PRIMARY	Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Baseline, Day 11	Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.	unitless	LEAST_SQUARES_MEAN
PRIMARY	Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)	Baseline through Day 85	Phase 2: All randomized participants who received at least one dose of study drug.	percentage of participants	NUMBER
PRIMARY	Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)	Day 29 Post-dose	Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.	micrograms per milliliter (μg/mL)	GEOMETRIC_MEAN
PRIMARY	Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)	Day 29 Post-dose	Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.	micrograms per milliliter (μg/mL)	GEOMETRIC_MEAN
PRIMARY	Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]	Day 60 Post-dose	Phase 2/3: All randomized participants who received a complete dose of Bebtelovimab and had at least 1 post-dose PK sample.	microgramday per milliliter (μgday/mL)	GEOMETRIC_MEAN
SECONDARY	Phase 3: Percentage of Participants Demonstrating Symptom Resolution	Day 11	Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values	percentage of participants	NUMBER
SECONDARY	Phase 3: Percentage of Participants Demonstrating Symptom Improvement	Day 11	Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values	percentage of participants	NUMBER
SECONDARY	Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause	Baseline through Day 85	Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.	percentage of participants	NUMBER

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group97

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab	7.0	95% Confidence Interval 4.8 to 9.2	percentage of participants
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	2.1	95% Confidence Interval 0.9 to 3.4	percentage of participants
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab	6.8	95% Confidence Interval 5.1 to 8.6	percentage of participants
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	0.8	95% Confidence Interval 0.0 to 1.5	percentage of participants
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	34.8	95% Confidence Interval 26.9 to 42.6	percentage of participants
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	10.8	95% Confidence Interval 6.6 to 15.0	percentage of participants
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Part A: Placebo	-3.80	Standard Error 0.141	unitless
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Phase 2: 700 mg Bamlanivimab	-3.72	Standard Error 0.170	unitless
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Phase 2: 2800 mg Bamlanivimab	-4.08	Standard Error 0.168	unitless
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load	Phase 2: 7000 mg Bamlanivimab	-3.49	Standard Error 0.175	unitless

1 to 10 of 97Source ClinicalTrials.gov

See all 97 results by group

Participant flow72

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 2: Placebo	156
Overall Study	STARTED	Phase 2: 700 mg Bamlanivimab	101
Overall Study	STARTED	Phase 2: 2800 mg Bamlanivimab	107
Overall Study	STARTED	Phase 2: 7000 mg Bamlanivimab	101
Overall Study	STARTED	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	112
Overall Study	STARTED	Phase 3: Placebo	776
Overall Study	STARTED	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	518
Overall Study	STARTED	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	513
Overall Study	STARTED	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	141
Overall Study	STARTED	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	213

1 to 10 of 72Source ClinicalTrials.gov

See all 72 participant flow

Adverse events4,452

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	Phase 2: Placebo	0	156	0
other	Anaemia	Blood and lymphatic system disorders	Phase 2: 700 mg Bamlanivimab	0	101	0
other	Anaemia	Blood and lymphatic system disorders	Phase 2: 2800 mg Bamlanivimab	0	107	0
other	Anaemia	Blood and lymphatic system disorders	Phase 2: 7000 mg Bamlanivimab	0	101	0
other	Anaemia	Blood and lymphatic system disorders	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	0	112	0
other	Anaemia	Blood and lymphatic system disorders	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	0	518	0
other	Anaemia	Blood and lymphatic system disorders	Phase 3: Placebo	1	776	1
other	Anaemia	Blood and lymphatic system disorders	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	4	513	4
other	Anaemia	Blood and lymphatic system disorders	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	0	141	0
other	Anaemia	Blood and lymphatic system disorders	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	2	213	2

1 to 10 of 4,452Source ClinicalTrials.gov

See all 4,452 adverse events

Adverse event totals36

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 2: Placebo	0	156
Total, all-cause mortality	Phase 2: 700 mg Bamlanivimab	0	101
Total, all-cause mortality	Phase 2: 2800 mg Bamlanivimab	0	107
Total, all-cause mortality	Phase 2: 7000 mg Bamlanivimab	0	101
Total, all-cause mortality	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	0	112
Total, all-cause mortality	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	0	518
Total, all-cause mortality	Phase 3: Placebo	15	776
Total, all-cause mortality	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	0	513
Total, all-cause mortality	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	0	141
Total, all-cause mortality	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	0	213

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse event totals

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33113295	DERIVED	PubMed
33475701	DERIVED	PubMed
34260849	DERIVED	PubMed
34346827	DERIVED	PubMed
34374951	DERIVED	PubMed
34473343	DERIVED	PubMed
34718468	DERIVED	PubMed
35493124	DERIVED	PubMed
35713300	DERIVED	PubMed
37329415	DERIVED	PubMed

1 to 10 of 11

See all 11 papers

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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