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)

August 30, 2021 updated by: AbbVie

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

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 Overview

Detailed Description

Part B of this study was not conducted.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Budapest, Hungary, 1023
        • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 226016
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 225827
      • Tel Hashomer, Ramat Gan, Israel, 52621
        • Sheba Medical Center /ID# 225857
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht /ID# 225919
      • Caguas, Puerto Rico, 00726
        • San Juan Bautista School of Medicine /ID# 225963
      • Manati, Puerto Rico, 00674
        • Manati Medical Center /ID# 225936
    • California
      • Glendale, California, United States, 91206-4007
        • Glendale Adventist Medical Center /ID# 225188
    • Florida
      • Cutler Bay, Florida, United States, 33157-6608
        • Beautiful Minds Clinical Research Center /ID# 228708
      • Miami, Florida, United States, 33136
        • University of Miami /ID# 225038
      • West Palm Beach, Florida, United States, 33407-3100
        • Triple O Research Institute /ID# 228612
    • Illinois
      • Chicago, Illinois, United States, 60612-7232
        • University of Illinois Hospital and Health Sciences System /ID# 224323
    • Kentucky
      • Pikeville, Kentucky, United States, 41501-1689
        • Pikeville Medical Center /ID# 224539
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901-1766
        • Saint Peter's University Hospital /ID# 225183
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center /ID# 225258
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital /ID# 224541
    • South Carolina
      • Greenville, South Carolina, United States, 29605-4210
        • Prisma Health Children's Hospital Upstate /ID# 224556
    • Texas
      • Beaumont, Texas, United States, 77702-1100
        • Gadolin Research, LLC /ID# 229394

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 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:

  • Have an oxygen saturation (SpO2) < 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <= 200 mmHg at randomization.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Group 1: ABBV-47D11 Dose A
Participants will receive ABBV-47D11 Dose A on Day 1.
Intravenous (IV) infusion.
Placebo Comparator: Part A: Group 1: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Intravenous (IV) infusion.
Experimental: Part A: Group 2: ABBV-47D11 Dose B
Participants will receive ABBV-47D11 Dose B on Day 1.
Intravenous (IV) infusion.
Placebo Comparator: Part A: Group 2: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Intravenous (IV) infusion.
Experimental: Part A: Group 3: ABBV-47D11 Dose C
Participants will receive ABBV-47D11 Dose C on Day 1.
Intravenous (IV) infusion.
Placebo Comparator: Part A: Group 3: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Intravenous (IV) infusion.
Experimental: Part B: Group 1: ABBV-2B04 Dose A
Participants will receive ABBV-2B04 Dose A on Day 1.
Intervenous (IV) Infusion
Experimental: 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.
Intravenous (IV) infusion.
Intervenous (IV) Infusion
Placebo Comparator: Part B: Group 1: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
Intravenous (IV) infusion.
Intervenous (IV) Infusion
Experimental: Part B: Group 2: ABBV-2B04 Dose B
Participants will receive ABBV-2B04 Dose B on Day 1.
Intervenous (IV) Infusion
Experimental: 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.
Intravenous (IV) infusion.
Intervenous (IV) Infusion
Placebo Comparator: Part B: Group 2: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
Intravenous (IV) infusion.
Intervenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)
Time Frame: Up to Day 106
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
Time Frame: Up to Day 106
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
Up to Day 106

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Serum Concentration (Cmax) of ABBV-47D11
Time Frame: Up to Day 85
Maximum observed serum concentration (Cmax) of ABBV-47D11.
Up to Day 85
Time to Cmax (Tmax) of ABBV-47D11
Time Frame: Up to Day 85
Time to maximum serum concentration of ABBV-47D11.
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
Time Frame: Up to Day 29
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
Time Frame: Up to Day 85
Terminal phase elimination half-life (t1/2) of ABBV-47D11.
Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11
Time Frame: Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.
Up to Day 85
Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11
Time Frame: Up to Day 85
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
Time Frame: Up to Day 85
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)
Time Frame: Baseline (Day 1) through Day 29
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
Time Frame: Up to Day 29
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
Time Frame: Up to Day 15
Number of participants with negative SARS-CoV-2 RNA by RT-PCR.
Up to Day 15
Maximum Observed Serum Concentration (Cmax) of ABBV-2B04
Time Frame: Up to Day 85
Maximum observed serum concentration (Cmax) of ABBV-2B04.
Up to Day 85
Time to Cmax (Tmax) of ABBV-2B04
Time Frame: Up to Day 85
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
Time Frame: Up to Day 29
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
Time Frame: Up to Day 85
Terminal phase elimination half-life (t1/2) of ABBV-2B04.
Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04
Time Frame: Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.
Up to Day 85
Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04
Time Frame: Up to Day 85
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
Time Frame: Up to Day 85
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.
Up to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2020

Primary Completion (Actual)

August 24, 2021

Study Completion (Actual)

August 24, 2021

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on CoronaVirus Disease-2019 (COVID-19)

Clinical Trials on ABBV-47D11

3
Subscribe