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)

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT04644120

Collaborator

(none)

Enrollment

Locations

Arms

8.4

Actual Duration (Months)

1.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Dec 10, 2020

Actual Primary Completion Date :

Aug 24, 2021

Actual Study Completion Date :

Aug 24, 2021

Arms and Interventions

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

Primary Outcome Measures

Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) [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.
Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions [Up to Day 106]
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 [Up to Day 85]
Maximum observed serum concentration (Cmax) of ABBV-47D11.
Time to Cmax (Tmax) of ABBV-47D11 [Up to Day 85]
Time to maximum serum concentration 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]
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11 [Up to Day 85]
Terminal phase elimination half-life (t1/2) of ABBV-47D11.
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 [Up to Day 85]
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.
Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11 [Up to Day 85]
Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11 [Up to Day 85]
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.
AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) [Baseline (Day 1) through Day 29]
Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.
Time to Negative SARS-CoV-2 by RT-PCR [Up to Day 29]
Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.
Negative SARS-CoV-2 RNA by RT-PCR [Up to Day 15]
Number of participants with negative SARS-CoV-2 RNA by RT-PCR.
Maximum Observed Serum Concentration (Cmax) of ABBV-2B04 [Up to Day 85]
Maximum observed serum concentration (Cmax) of ABBV-2B04.
Time to Cmax (Tmax) of ABBV-2B04 [Up to Day 85]
Time to maximum serum concentration 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]
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04 [Up to Day 85]
Terminal phase elimination half-life (t1/2) of ABBV-2B04.
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04 [Up to Day 85]
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.
Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04 [Up to Day 85]
Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04 [Up to Day 85]
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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