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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04638634
Registration number
NCT04638634
Ethics application status
Date submitted
19/11/2020
Date registered
20/11/2020
Date last updated
10/12/2021
Titles & IDs
Public title
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
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Scientific title
A Single Center, Phase 1, Single-Ascending Dose, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
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Secondary ID [1]
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CSL760_1001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 2019 (COVID-19)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - CSL760
Experimental: CSL760 (low dose) - Administered as an intravenous infusion
Experimental: CSL760 (high dose) - Administered as an intravenous infusion
Other interventions: CSL760
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total immunoglobulin (IgG) concentration of CSL760
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Assessment method [1]
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Timepoint [1]
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At 0,0.5,1,2,6,12,24, and 48 hours, and 7,14,28,49, and 91 days after end of IV infusion
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Primary outcome [2]
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Maximum concentration (Cmax) of CSL760
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Assessment method [2]
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Timepoint [2]
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Up to 91 days after end of IV infusion
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Primary outcome [3]
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Time of Cmax (tmax) of CSL760
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Assessment method [3]
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Timepoint [3]
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Up to 91 days after end of IV infusion
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Primary outcome [4]
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Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
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Assessment method [4]
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Timepoint [4]
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Up to 91 days after end of IV infusion
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Secondary outcome [1]
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Number of subjects with Treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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From start of infusion up to 91 days
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Secondary outcome [2]
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Percent of subjects with TEAEs
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Assessment method [2]
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Timepoint [2]
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From start of infusion up to 91 days
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Secondary outcome [3]
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Number of subjects with Serious adverse events (SAEs)
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Assessment method [3]
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Timepoint [3]
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From start of infusion up to 91 days
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Secondary outcome [4]
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Percent of subjects with SAEs
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Assessment method [4]
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Timepoint [4]
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From start of infusion up to 91 days
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Secondary outcome [5]
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Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
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Assessment method [5]
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Timepoint [5]
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From start of infusion up to 91 days
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Secondary outcome [6]
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Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
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Assessment method [6]
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Timepoint [6]
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From start of infusion up to 91 days
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Eligibility
Key inclusion criteria
- Male or female 18 to 65 years of age
- Female subjects must be postmenopausal or have a negative pregnancy test
- Body weight in the range of = 50 kg and = 100 kg and have a body mass index of = 18 to
= 32 kg/m2
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History of acute or chronic renal failure, thromboembolism, chronic respiratory
illness, aseptic meningitis syndrome, or recurrent severe headaches or migraines.
- Positive viral serology test for HIV -1/2 antibody, hepatitis B virus surface antigen,
or hepatitis C virus antibody
- Positive viral serology test for SARS-CoV-2 antibodies
- Received any live viral or bacterial vaccinations within 8 weeks
- Evidence of current active infection.
- Known malignancy or a history of malignancy in the past 5 years
- Female subject of childbearing potential or fertile male subject either not using or
not willing to use an acceptable double barrier method of contraception to avoid
pregnancy during the study
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Study design
Purpose of the study
Other
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/06/2021
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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CMAX Clinical Research - Adelaide
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Recruitment postcode(s) [1]
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SA 5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of
human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute
respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for
COVID-19 (Coronavirus Disease 2019).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04638634
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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CSL Innovation Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04638634
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