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)
NCT ID: NCT04644120
Last Updated: 2021-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2020-12-10
2021-08-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part A: Group 1: ABBV-47D11 Dose A
Participants will receive ABBV-47D11 Dose A on Day 1.
ABBV-47D11
Intravenous (IV) infusion.
Part A: Group 1: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Placebo for ABBV-47D11
Intravenous (IV) infusion.
Part A: Group 2: ABBV-47D11 Dose B
Participants will receive ABBV-47D11 Dose B on Day 1.
ABBV-47D11
Intravenous (IV) infusion.
Part A: Group 2: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Placebo for ABBV-47D11
Intravenous (IV) infusion.
Part A: Group 3: ABBV-47D11 Dose C
Participants will receive ABBV-47D11 Dose C on Day 1.
ABBV-47D11
Intravenous (IV) infusion.
Part A: Group 3: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Placebo for ABBV-47D11
Intravenous (IV) infusion.
Part B: Group 1: ABBV-2B04 Dose A
Participants will receive ABBV-2B04 Dose A on Day 1.
ABBV-2B04
Intervenous (IV) Infusion
Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11
Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1.
ABBV-47D11
Intravenous (IV) infusion.
ABBV-2B04
Intervenous (IV) Infusion
Part B: Group 1: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
Placebo for ABBV-47D11
Intravenous (IV) infusion.
Placebo for ABBV-2B04
Intervenous (IV) Infusion
Part B: Group 2: ABBV-2B04 Dose B
Participants will receive ABBV-2B04 Dose B on Day 1.
ABBV-2B04
Intervenous (IV) Infusion
Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11
Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1.
ABBV-47D11
Intravenous (IV) infusion.
ABBV-2B04
Intervenous (IV) Infusion
Part B: Group 2: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
Placebo for ABBV-47D11
Intravenous (IV) infusion.
Placebo for ABBV-2B04
Intervenous (IV) Infusion
Interventions
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ABBV-47D11
Intravenous (IV) infusion.
Placebo for ABBV-47D11
Intravenous (IV) infusion.
ABBV-2B04
Intervenous (IV) Infusion
Placebo for ABBV-2B04
Intervenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* Must have \>= 1 symptom associated with COVID-19 with an onset of \<= 8 days prior to randomization.
* Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study
Exclusion Criteria
* Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
* Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Glendale Adventist Medical Center /ID# 225188
Glendale, California, United States
Beautiful Minds Clinical Research Center /ID# 228708
Cutler Bay, Florida, United States
University of Miami /ID# 225038
Miami, Florida, United States
Triple O Research Institute /ID# 228612
West Palm Beach, Florida, United States
University of Illinois Hospital and Health Sciences System /ID# 224323
Chicago, Illinois, United States
Pikeville Medical Center /ID# 224539
Pikeville, Kentucky, United States
Saint Peter's University Hospital /ID# 225183
New Brunswick, New Jersey, United States
Saint Michael's Medical Center /ID# 225258
Newark, New Jersey, United States
The Christ Hospital /ID# 224541
Cincinnati, Ohio, United States
Prisma Health Children's Hospital Upstate /ID# 224556
Greenville, South Carolina, United States
Gadolin Research, LLC /ID# 229394
Beaumont, Texas, United States
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015
Budapest, , Hungary
Semmelweis Egyetem /ID# 226016
Budapest, , Hungary
Hadassah Medical Center-Hebrew University /ID# 225827
Jerusalem, , Israel
Sheba Medical Center /ID# 225857
Tel Hashomer, Ramat Gan, , Israel
Universitair Medisch Centrum Utrecht /ID# 225919
Utrecht, , Netherlands
San Juan Bautista School of Medicine /ID# 225963
Caguas, , Puerto Rico
Manati Medical Center /ID# 225936
Manatí, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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2020-005203-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-404
Identifier Type: -
Identifier Source: org_study_id
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