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

Withdrawn

• Conditions: Coronavirus; COVID-19; 10047438

• Registration Number: NL-OMON50807
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Trial never started

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-08-23
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

1. Adult, at least 18 years old, weighing at least 45 kg
2. 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 (note: timing based on date of test result)
3. Must have >= 1 symptom associated with COVID-19 (e.g., fever, chills/sweats,
cough, shortness of breath/dyspnea, sore throat, fatigue, dyspnea, myalgia,
headache, congestion, gastrointestinal symptoms [nausea, vomiting, diarrhea],
new loss of taste or smell) with an onset of <= 8 days prior to randomization
AND evidence of lower respiratory tract infection by clinical assessment or
imaging
4. Hospitalized or plans for hospital admission due to COVID-19 at the time of
randomization

Exclusion Criteria

1. Must not 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
2. Not requiring high-flow oxygen therapy/non-invasive or invasive mechanical
ventilation/ECMO or anticipated impending need for high-flow oxygen
therapy/non-invasive or invasive mechanical ventilation/ECMO

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety Endpoints (Primary) - up to Day 106<br /><br>1. Number of Participants With Study-Drug Related Grade 3 or Higher Adverse<br /><br>Events (AEs)<br /><br>2. Number of Participants With Study-Drug Related Grade 3 or Higher<br /><br>Infusion-Related Reactions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 up to Day 85<br /><br>2. Time to Cmax (Tmax) of ABBV-47D11 up to Day 85<br /><br>3. Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to<br /><br>Day 29 (672 hour) (AUC0-672h) of ABBV-47D11<br /><br>4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11 up to Day 85<br /><br>5. AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 up to Day 85<br /><br>6. Detection of Anti-Drug Antibodies (ADA) up to Day 85<br /><br>7. Detection of Neutralizing Anti-Drug Antibodies (nADA) up to Day 85<br /><br>8. AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA)<br /><br>Reverse Transcription-Polymerase Chain Reaction (RT-PCR) through Day 29<br /><br>9. Time to Negative SARS-CoV-2 by RT-PCR up to Day 29<br /><br>10. Negative SARS-CoV-2 RNA by RT-PCR up to Day 15</p><br>