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Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 Moves Through the Body of Adult Participants Hospitalized With Coronavirus Disease 2019 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04644120
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 in participants hospitalized 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 is an investigational anti-SARS-CoV-2 monoclonal antibody being developed for the treatment of COVID-19. Participants will receive either placebo or ABBV-47D11. There is a 1 in 4 chance that participants will be assigned to placebo. Around 24 adult participants hospitalized for a diagnosis of COVID-19 will be enrolled in approximately 10 to 30 sites globally.

Participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo of Day 1.

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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 in Adults Hospitalized With COVID-19
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : August 2, 2021
Estimated Study Completion Date : August 3, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: ABBV-47D11 Dose A
Participants will receive ABBV-47D11 Dose A on Day 1.
Drug: ABBV-47D11
Intravenous (IV) infusion.

Placebo Comparator: 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: Group 2: ABBV-47D11 Dose B
Participants will receive ABBV-47D11 Dose B on Day 1.
Drug: ABBV-47D11
Intravenous (IV) infusion.

Placebo Comparator: 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: Group 3: ABBV-47D11 Dose C
Participants will receive ABBV-47D11 Dose C on Day 1.
Drug: ABBV-47D11
Intravenous (IV) infusion.

Placebo Comparator: Group 3: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.




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) [ Time Frame: Up to Day 85 ]
    Anti-drug antibodies will be detected using a tiered approach.

  7. Detection of Neutralizing Anti-Drug Antibodies (nADA) [ Time Frame: Up to Day 85 ]
    Neutralizing anti-drug antibodies will be detected using a tiered approach.

  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.



Information from the National Library of Medicine

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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 AND evidence of lower respiratory tract infection by clinical assessment or imaging.
  • Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization.

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 oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
  • Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.

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


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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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: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases