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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04644120 | Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) | PHASE1 | COMPLETED | 25 | — | — | Dec 10, 2020 | Aug 24, 2021 | Sep 2, 2021 | 18 | United States, Hungary +3 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
| Arm | Type | Description |
|---|---|---|
| Part A: Group 1: ABBV-47D11 Dose A | EXPERIMENTAL | Participants will receive ABBV-47D11 Dose A on Day 1. |
| Part A: Group 1: Placebo for ABBV-47D11 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part A: Group 2: ABBV-47D11 Dose B | EXPERIMENTAL | Participants will receive ABBV-47D11 Dose B on Day 1. |
| Part A: Group 2: Placebo for ABBV-47D11 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part A: Group 3: ABBV-47D11 Dose C | EXPERIMENTAL | Participants will receive ABBV-47D11 Dose C on Day 1. |
| Part A: Group 3: Placebo for ABBV-47D11 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part B: Group 1: ABBV-2B04 Dose A | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose A on Day 1. |
| Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11 | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1. |
| Part B: Group 1: Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. |
| Part B: Group 2: ABBV-2B04 Dose B | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose B on Day 1. |
| Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11 | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1. |
| Part B: Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. |
| Name | Type | Description |
|---|---|---|
| ABBV-47D11 | DRUG | Intravenous (IV) infusion. |
| Placebo for ABBV-47D11 | DRUG | Intravenous (IV) infusion. |
| ABBV-2B04 | DRUG | Intervenous (IV) Infusion |
| Placebo for ABBV-2B04 | DRUG | Intervenous (IV) Infusion |
Inclusion Criteria: * Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization. * Must have \>= 1 symptom associated with COVID-19 with an onset of \<= 8 days prior to randomization. * H...