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NCT Number: NCT04644120

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)

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.

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Key information

Conditions

CoronaVirus Disease-2019 (COVID-19) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015, Budapest, Hungary

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About this study

Part B of this study was not conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-47D11

Drug

Intravenous (IV) infusion.

Placebo for ABBV-47D11

Drug

Intravenous (IV) infusion.

ABBV-2B04

Drug

Intervenous (IV) Infusion

Placebo for ABBV-2B04

Drug

Intervenous (IV) Infusion

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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