To evaluate the safety and tolerability of single ascending doses of ABBV-47D11 in subjects hospitalized with COVID-19.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Endpoints (Primary) - up to Day 106
1. Number of Participants With Study-Drug Related Grade 3 or Higher Adverse
Events (AEs)
2. Number of Participants With Study-Drug Related Grade 3 or Higher
Infusion-Related Reactions
Secondary outcome
1. Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 up to Day 85
2. Time to Cmax (Tmax) of ABBV-47D11 up to Day 85
3. 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 up to Day 85
5. AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 up to Day 85
6. Detection of Anti-Drug Antibodies (ADA) up to Day 85
7. Detection of Neutralizing Anti-Drug Antibodies (nADA) up to Day 85
8. AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA)
Reverse Transcription-Polymerase Chain Reaction (RT-PCR) through Day 29
9. Time to Negative SARS-CoV-2 by RT-PCR up to Day 29
10. Negative SARS-CoV-2 RNA by RT-PCR up to Day 15
Background 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.
Study objective
To evaluate the safety and tolerability of single ascending doses of ABBV-47D11
in subjects hospitalized with COVID-19.
Study design
Randomized, double-blind, placebo-controlled ascending dose study.
Intervention
Participants will receive single intravenous (into the veins) infusion of
ABBV-47D11 or placebo of Day 1.
Study burden and risks
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.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-005203-39-NL |
| ClinicalTrials.gov | NCT04644120 |
| CCMO | NL75962.041.20 |