Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 1,180 | — | — | Aug 2, 2020 | May 20, 2021 | Feb 4, 2022 | 27 | United States |
| NCT04701658 | A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) | PHASE2 | COMPLETED | 109 | — | — | Feb 1, 2021 | Jun 22, 2021 | Nov 16, 2021 | 1 | United States |
| NCT04634409 | A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness | PHASE2 | COMPLETED | 1,755 | — | — | Oct 29, 2020 | Oct 18, 2021 | Jul 1, 2022 | 141 | United States, Argentina +1 |
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.
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.
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.
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).
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).
| Arm | Type | Description |
|---|---|---|
| Bamlanivimab (Part 1) | EXPERIMENTAL | Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab. |
| Placebo (Part 1) | PLACEBO_COMPARATOR | Participants received single IV infusion of Placebo. |
| Bamlanivimab (Part 2-Prevention) | EXPERIMENTAL | Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2. |
| Bamlanivimab + Etesevimab (Part 2-Prevention) | EXPERIMENTAL | Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2. |
| Placebo Comparator: Placebo (Part 2-Prevention) | PLACEBO_COMPARATOR | Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2. |
| Bamlanivimab (Part 2 - Treatment) | EXPERIMENTAL | Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2. |
| Bamlanivimab + Etesevimab (Part 2- Treatment) | EXPERIMENTAL | Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2. |
| Bamlanivimab (Part 3) | EXPERIMENTAL | Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab.\] |
| Bamlanivimab + Etesevimab (Part 3) | EXPERIMENTAL | Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record. \[Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.\] |
| Bamlanivimab | EXPERIMENTAL | Participants received 700 milligram single intravenous infusion of Bamlanivimab. |
| Controls | NO_INTERVENTION | Matched controls who received standard of care. \[The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.\] |
| Placebo (Pbo) | PLACEBO_COMPARATOR | Treatment 1: Pbo administered intravenously (IV). Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV. Treatment 11: Pbo For 175 mg Bebtelovimab (BEB) \& 700 mg BAM +1400 mg Etesevimab ( ETE) +175 mg BEB (Low Risk Participants) administered IV. Pooled Placebo (Addendum 4, IV) administered IV. Pooled Placebo (Addendum 4, SC) administered SC. |
| BAM + ETE | EXPERIMENTAL | Treatment 2: 175 mg BAM +350 mg ETE administered IV. Treatment 3: 700 mg BAM +1400 mg ETE administered IV. Treatment 4: 2800 mg BAM +2800 mg ETE administered IV. Treatment 6: 350 mg BAM +700 mg ETE administered IV. Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV. 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV. 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV. |
| BAM | EXPERIMENTAL | Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV. |
| BAM + VIR-7831 | EXPERIMENTAL | Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV. |
| BEB | EXPERIMENTAL | Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) administered IV. 70 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 1750 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 280 mg BEB (Addendum 4, SC) administered SC. 560 mg BEB (Addendum 4, SC) administered SC. |
| BAM+ ETE + BEB | EXPERIMENTAL | Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV. |
| Name | Type | Description |
|---|---|---|
| Bamlanivimab | DRUG | Administered IV. |
| Placebo | DRUG | Administered IV. |
| Etesevimab | DRUG | Administered IV. |
| VIR-7831 | DRUG | Administered IV. |
| Bebtelovimab | DRUG | Administered IV. |
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 requirement...