Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005203-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.
ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.
In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Part B of this study was not conducted.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-47D11 | Drug | Intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) | 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. | Up to Day 106 |
| Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions | Participants will be assessed for the infusion-related reaction considered drug-related by the investigator. | Up to Day 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 | Maximum observed serum concentration (Cmax) of ABBV-47D11. | Up to Day 85 |
| Time to Cmax (Tmax) of ABBV-47D11 | Time to maximum serum concentration of ABBV-47D11. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Adventist Medical Center /ID# 225188 | Glendale | California | 91206-4007 | United States | ||
| Beautiful Minds Clinical Research Center /ID# 228708 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
|
| Placebo for ABBV-47D11 | Drug | Intravenous (IV) infusion. |
|
| ABBV-2B04 | Drug | Intervenous (IV) Infusion |
|
| Placebo for ABBV-2B04 | Drug | Intervenous (IV) Infusion |
|
| Up to Day 85 |
| Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11 | Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11. | Up to Day 29 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11 | Terminal phase elimination half-life (t1/2) of ABBV-47D11. | Up to Day 85 |
| AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 | AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11. | Up to Day 85 |
| Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11 | Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11. | Up to Day 85 |
| Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11 | Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11. | Up to Day 85 |
| AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) | Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA. | Baseline (Day 1) through Day 29 |
| Time to Negative SARS-CoV-2 by RT-PCR | Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR. | Up to Day 29 |
| Negative SARS-CoV-2 RNA by RT-PCR | Number of participants with negative SARS-CoV-2 RNA by RT-PCR. | Up to Day 15 |
| Maximum Observed Serum Concentration (Cmax) of ABBV-2B04 | Maximum observed serum concentration (Cmax) of ABBV-2B04. | Up to Day 85 |
| Time to Cmax (Tmax) of ABBV-2B04 | Time to maximum serum concentration of ABBV-2B04. | Up to Day 85 |
| Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04 | Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04. | Up to Day 29 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04 | Terminal phase elimination half-life (t1/2) of ABBV-2B04. | Up to Day 85 |
| AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04 | AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04. | Up to Day 85 |
| Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04 | Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04. | Up to Day 85 |
| Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04 | Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04. | Up to Day 85 |
| Cutler Bay |
| Florida |
| 33157-6608 |
| United States |
| University of Miami /ID# 225038 | Miami | Florida | 33136 | United States |
| Triple O Research Institute /ID# 228612 | West Palm Beach | Florida | 33407-3100 | United States |
| University of Illinois Hospital and Health Sciences System /ID# 224323 | Chicago | Illinois | 60612-7232 | United States |
| Pikeville Medical Center /ID# 224539 | Pikeville | Kentucky | 41501-1689 | United States |
| Saint Peter's University Hospital /ID# 225183 | New Brunswick | New Jersey | 08901-1766 | United States |
| Saint Michael's Medical Center /ID# 225258 | Newark | New Jersey | 07102 | United States |
| The Christ Hospital /ID# 224541 | Cincinnati | Ohio | 45219 | United States |
| Prisma Health Children's Hospital Upstate /ID# 224556 | Greenville | South Carolina | 29605-4210 | United States |
| Gadolin Research, LLC /ID# 229394 | Beaumont | Texas | 77702-1100 | United States |
| Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015 | Budapest | 1023 | Hungary |
| Semmelweis Egyetem /ID# 226016 | Budapest | 1085 | Hungary |
| Hadassah Medical Center-Hebrew University /ID# 225827 | Jerusalem | 91120 | Israel |
| Sheba Medical Center /ID# 225857 | Tel Hashomer, Ramat Gan | 52621 | Israel |
| Universitair Medisch Centrum Utrecht /ID# 225919 | Utrecht | 3584 CX | Netherlands |
| San Juan Bautista School of Medicine /ID# 225963 | Caguas | 00726 | Puerto Rico |
| Manati Medical Center /ID# 225936 | Manati | 00674 | Puerto Rico |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided