Trial · NCT04427501
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| 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. | microgram*day per milliliter (μg*day/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 |
| SECONDARY | Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value. | unitless | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 3: Time to Sustained Symptom Resolution | Baseline through Day 29 | Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43 | Days | MEDIAN |
| SECONDARY | Phase 3: Time to SARS-CoV-2 Viral Clearance | Baseline through Day 29 | Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114 | Days | MEDIAN |
| SECONDARY | Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization | Baseline, Day 11 | Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization. | unitless | LEAST_SQUARES_MEAN |
| SECONDARY | Phase 2: Percentage of Participants Demonstrating Symptom Resolution | Day 11 | Phase 2: 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 2: Percentage of Participants Demonstrating Symptom Improvement | Day 11 | Phase 2: 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 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab | Day 29 Post-dose | Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample. | Microgram/milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab | Day 29 Post-dose | Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause | Baseline through Day 85 | Phase 2: All participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Time to SARS-CoV-2 Viral Clearance | Baseline through Day 29 | Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45 | Days | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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