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)
Public ClinicalTrials.gov record NCT04644120. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04644120
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Interventions
- ABBV-47D11 Drug
- Placebo for ABBV-47D11 Drug
- ABBV-2B04 Drug
- Placebo for ABBV-2B04 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 9, 2020
- Primary completion
- Aug 23, 2021
- Completion
- Aug 23, 2021
- Last update posted
- Sep 1, 2021
2020 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Glendale Adventist Medical Center /ID# 225188 | Glendale | California | 91206-4007 | — |
| Beautiful Minds Clinical Research Center /ID# 228708 | Cutler Bay | Florida | 33157-6608 | — |
| University of Miami /ID# 225038 | Miami | Florida | 33136 | — |
| Triple O Research Institute /ID# 228612 | West Palm Beach | Florida | 33407-3100 | — |
| University of Illinois Hospital and Health Sciences System /ID# 224323 | Chicago | Illinois | 60612-7232 | — |
| Pikeville Medical Center /ID# 224539 | Pikeville | Kentucky | 41501-1689 | — |
| Saint Peter's University Hospital /ID# 225183 | New Brunswick | New Jersey | 08901-1766 | — |
| Saint Michael's Medical Center /ID# 225258 | Newark | New Jersey | 07102 | — |
| The Christ Hospital /ID# 224541 | Cincinnati | Ohio | 45219 | — |
| Prisma Health Children's Hospital Upstate /ID# 224556 | Greenville | South Carolina | 29605-4210 | — |
| Gadolin Research, LLC /ID# 229394 | Beaumont | Texas | 77702-1100 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04644120, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2021 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04644120 live on ClinicalTrials.gov.