Trial · NCT04634409
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
NCT04634409, Phase 2, Completed, Eli Lilly and Company; results first posted 2022-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness. Trials, record NCT04634409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04634409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
- NCT number
- NCT04634409
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,755 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- COVID-19
- Interventions
- Bamlanivimab, Etesevimab, Placebo, VIR-7831, Bebtelovimab
- First posted
- 2020-11-18
- Last updated
- 2022-07-01
- Results first posted
- 2022-07-01
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1. |
| Primary | Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF). |
| Primary | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF). |
| Secondary | Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF). |
| Secondary | Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF). |
| Secondary | Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1. |
| Secondary | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF). |
| Secondary | Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF). |
| Secondary | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause |
| Secondary | Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Day 7 | Treatment 1-6 and Unintentional Dosing arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| PRIMARY | Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Treatment 7-8, Amendments (C-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| PRIMARY | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| SECONDARY | Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Treatment 12 -13, Amendment (f) High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| SECONDARY | Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| SECONDARY | Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| SECONDARY | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Addendum (4) Arm A - Intravenous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| SECONDARY | Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | Addendum (4) Arm B - Subcutaneous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement. | percentage of participants | NUMBER |
| SECONDARY | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Treatment 1-6 and Unintentional Dosing arms: All participants randomly assigned and who received any amount of study drug. | percentage of participants | NUMBER |
| SECONDARY | Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Treatment 7-8, Amendment (C-E): All participants randomly assigned and who received any amount of study drug. No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before) |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Treatment 1: Pbo | 27.7 | 95% Confidence Interval 20.7 to 34.8 | percentage of participants | |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Treatment 2: 175 mg BAM +350 mg ETE | 12.2 | 95% Confidence Interval 5.1 to 19.3 | percentage of participants | |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Treatment 3: 700 mg BAM +1400 mg ETE | 10.8 | 95% Confidence Interval 6.0 to 15.7 | percentage of participants | |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Treatment 4: 2800 mg BAM +2800 mg ETE | 7.8 | 95% Confidence Interval 2.6 to 12.9 | percentage of participants | |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Treatment 5: 700 mg BAM | 14.3 | 95% Confidence Interval 7.6 to 21.0 | percentage of participants | |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Treatment 6: 350 mg BAM +700 mg ETE | 7.9 | 95% Confidence Interval 2.7 to 13.2 | percentage of participants | |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27 | Unintentional Dosing: 700 mg BAM +700 mg ETE | 10.0 | 95% Confidence Interval 0.0 to 23.1 | percentage of participants | |
| Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 9.9 | 95% Confidence Interval 4.1 to 15.7 | percentage of participants | |
| Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 29.7 | 95% Confidence Interval 20.8 to 38.6 | percentage of participants | |
| Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) | 12.0 | 95% Confidence Interval 6.3 to 17.7 | percentage of participants |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment 1: Pbo | 155 | |
| Overall Study | STARTED | Treatment 2: 175 mg BAM +350 mg ETE | 83 | |
| Overall Study | STARTED | Treatment 3: 700 mg BAM +1400 mg ETE | 158 | |
| Overall Study | STARTED | Treatment 4: 2800 mg BAM +2800 mg ETE | 103 | |
| Overall Study | STARTED | Treatment 5: 700 mg BAM | 105 | |
| Overall Study | STARTED | Treatment 6: 350 mg BAM +700 mg ETE | 101 | |
| Overall Study | STARTED | Unintentional Dosing: 700 mg BAM +700 mg ETE | 20 | |
| Overall Study | STARTED | Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 101 | |
| Overall Study | STARTED | Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 101 | |
| Overall Study | STARTED | Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) | 125 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events4,401
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 | Treatment 1: Pbo | 0 | 155 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 2: 175 mg BAM +350 mg ETE | 0 | 83 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 3: 700 mg BAM +1400 mg ETE | 0 | 158 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 4: 2800 mg BAM +2800 mg ETE | 0 | 103 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 5: 700 mg BAM | 0 | 105 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 6: 350 mg BAM +700 mg ETE | 0 | 101 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Unintentional Dosing: 700 mg BAM +700 mg ETE | 0 | 20 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 0 | 101 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 0 | 101 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) | 0 | 125 | 0 |
1 to 10 of 4,401Source ClinicalTrials.gov
See all 4,401 adverse eventsAdverse event totals81
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment 1: Pbo | 0 | 155 |
| Total, all-cause mortality | Treatment 2: 175 mg BAM +350 mg ETE | 0 | 83 |
| Total, all-cause mortality | Treatment 3: 700 mg BAM +1400 mg ETE | 0 | 158 |
| Total, all-cause mortality | Treatment 4: 2800 mg BAM +2800 mg ETE | 0 | 103 |
| Total, all-cause mortality | Treatment 5: 700 mg BAM | 0 | 105 |
| Total, all-cause mortality | Treatment 6: 350 mg BAM +700 mg ETE | 0 | 101 |
| Total, all-cause mortality | Unintentional Dosing: 700 mg BAM +700 mg ETE | 0 | 20 |
| Total, all-cause mortality | Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 0 | 101 |
| Total, all-cause mortality | Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | 0 | 101 |
| Total, all-cause mortality | Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) | 0 | 125 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse event totalsPapers4
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 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.
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/NCT04634409
GET https://conductscience.org/api/trials/v1/NCT04634409/registered?page=2