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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04644120
Recruitment Status : Completed
First Posted : November 25, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
CoronaVirus Disease-2019 (COVID-19) Drug: ABBV-47D11 Drug: Placebo for ABBV-47D11 Drug: ABBV-2B04 Drug: Placebo for ABBV-2B04 Phase 1

Detailed Description:
Part B of this study was not conducted.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 10, 2020
Actual Primary Completion Date : August 24, 2021
Actual Study Completion Date : August 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: Group 1: ABBV-47D11 Dose A
Participants will receive ABBV-47D11 Dose A on Day 1.
 Drug: ABBV-47D11
Intravenous (IV) infusion.
Placebo Comparator: Part A: Group 1: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
 Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.
Experimental: Part A: Group 2: ABBV-47D11 Dose B
Participants will receive ABBV-47D11 Dose B on Day 1.
 Drug: ABBV-47D11
Intravenous (IV) infusion.
Placebo Comparator: Part A: Group 2: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
 Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.
Experimental: Part A: Group 3: ABBV-47D11 Dose C
Participants will receive ABBV-47D11 Dose C on Day 1.
 Drug: ABBV-47D11
Intravenous (IV) infusion.
Placebo Comparator: Part A: Group 3: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
 Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.
Experimental: Part B: Group 1: ABBV-2B04 Dose A
Participants will receive ABBV-2B04 Dose A on Day 1.
 Drug: ABBV-2B04
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.
 Drug: ABBV-47D11
Intravenous (IV) infusion.

Drug: ABBV-2B04
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.
 Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.

Drug: Placebo for ABBV-2B04
Intervenous (IV) Infusion
Experimental: Part B: Group 2: ABBV-2B04 Dose B
Participants will receive ABBV-2B04 Dose B on Day 1.
 Drug: ABBV-2B04
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.
 Drug: ABBV-47D11
Intravenous (IV) infusion.

Drug: ABBV-2B04
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.
 Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.

Drug: Placebo for ABBV-2B04
Intervenous (IV) Infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 [ Time Frame: Up to Day 85 ]
    Maximum observed serum concentration (Cmax) of ABBV-47D11.

  2. Time to Cmax (Tmax) of ABBV-47D11 [ Time Frame: Up to Day 85 ]
    Time to maximum serum concentration of ABBV-47D11.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Maximum Observed Serum Concentration (Cmax) of ABBV-2B04 [ Time Frame: Up to Day 85 ]
    Maximum observed serum concentration (Cmax) of ABBV-2B04.

  12. Time to Cmax (Tmax) of ABBV-2B04 [ Time Frame: Up to Day 85 ]
    Time to maximum serum concentration of ABBV-2B04.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644120


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04644120    
Other Study ID Numbers: M20-404
2020-005203-39 ( EudraCT Number )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AbbVie:
CoronaVirus Disease-2019
COVID-19
Severe Acute Respiratory Syndrome Coronavirus-2
 SARS-CoV-2
ABBV-47D11
ABBV-2B04
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases