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) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644120
• Other study ID #: M20-404
• Secondary ID: 2020-005203-39
• Status: Completed
• Phase: Phase 1
• Start date: December 10, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: August 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Part B of this study was not conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CoronaVirus Disease-2019 (COVID-19)
• Coronavirus Infections

Intervention

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

Locations

Country	Name	City	State
Hungary	Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015	Budapest
Hungary	Semmelweis Egyetem /ID# 226016	Budapest
Israel	Hadassah Medical Center-Hebrew University /ID# 225827	Jerusalem
Israel	Sheba Medical Center /ID# 225857	Tel Hashomer, Ramat Gan
Netherlands	Universitair Medisch Centrum Utrecht /ID# 225919	Utrecht
Puerto Rico	San Juan Bautista School of Medicine /ID# 225963	Caguas
Puerto Rico	Manati Medical Center /ID# 225936	Manati
United States	Gadolin Research, LLC /ID# 229394	Beaumont	Texas
United States	University of Illinois Hospital and Health Sciences System /ID# 224323	Chicago	Illinois
United States	The Christ Hospital /ID# 224541	Cincinnati	Ohio
United States	Beautiful Minds Clinical Research Center /ID# 228708	Cutler Bay	Florida
United States	Glendale Adventist Medical Center /ID# 225188	Glendale	California
United States	Prisma Health Children's Hospital Upstate /ID# 224556	Greenville	South Carolina
United States	University of Miami /ID# 225038	Miami	Florida
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	Pikeville Medical Center /ID# 224539	Pikeville	Kentucky
United States	Triple O Research Institute /ID# 228612	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Hungary,  Israel,  Netherlands,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)	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
Primary	Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions	Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.	Up to Day 106
Secondary	Maximum Observed Serum Concentration (Cmax) of ABBV-47D11	Maximum observed serum concentration (Cmax) of ABBV-47D11.	Up to Day 85
Secondary	Time to Cmax (Tmax) of ABBV-47D11	Time to maximum serum concentration of ABBV-47D11.	Up to Day 85
Secondary	Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11	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
Secondary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11	Terminal phase elimination half-life (t1/2) of ABBV-47D11.	Up to Day 85
Secondary	AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11	AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.	Up to Day 85
Secondary	Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11	Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.	Up to Day 85
Secondary	Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11	Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.	Up to Day 85
Secondary	AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR)	Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.	Baseline (Day 1) through Day 29
Secondary	Time to Negative SARS-CoV-2 by RT-PCR	Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.	Up to Day 29
Secondary	Negative SARS-CoV-2 RNA by RT-PCR	Number of participants with negative SARS-CoV-2 RNA by RT-PCR.	Up to Day 15
Secondary	Maximum Observed Serum Concentration (Cmax) of ABBV-2B04	Maximum observed serum concentration (Cmax) of ABBV-2B04.	Up to Day 85
Secondary	Time to Cmax (Tmax) of ABBV-2B04	Time to maximum serum concentration of ABBV-2B04.	Up to Day 85
Secondary	Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04	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
Secondary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04	Terminal phase elimination half-life (t1/2) of ABBV-2B04.	Up to Day 85
Secondary	AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04	AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.	Up to Day 85
Secondary	Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04	Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.	Up to Day 85
Secondary	Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04	Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.	Up to Day 85