A Phase 2 interventional study of CSL324 and Placebo in Coronavirus Disease 2019 (COVID-19), sponsored by CSL Behring. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by CSL Behring · Phase 2, Interventional, and Treatment
This is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with SOC treatment, in subjects with COVID 19.
For the purposes of this study, standard of care (SOC) may include any written or established treatment protocol followed at the study site for the treatment of severe COVID-19 or its complications, including off-label use of marketed pharmaceutical products and / or products with emergency use authorization granted for the treatment of COVID-19 (ie, not yet marketed) (eg, remdesivir).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Meets ≥ 1 of the following criteria (subjects improving while on respiratory support still qualify):
Exclusion Criteria:
Currently enrolled, planning to enroll, or participated, within the last 30 days, in a clinical study requiring administration of an investigational product (ie, not yet marketed), including expanded access or compassionate use
Exceptions:
Intubated and requires mechanical ventilation (including ECMO) at time of randomization
Presence of any of the following comorbid conditions before randomization and prior to SARS-CoV-2 infection:
CSL324 administered intravenously
Biological: CSL324
Normal saline administered intravenously
Drug: Placebo
Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
Normal saline (0.9% sodium chloride)
Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation
Time frame: Randomization to Day 28
Proportion of deaths from all causes
Time frame: Randomization to Day 28
Proportion of subjects intubated
Time frame: Randomization to Day 28
Median length of stay in hospital
Time frame: Randomization to Day 28
Number and proportion of subjects with at least a 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale
Time frame: Randomization to Day 28
Number and proportion of subjects within each of the categories of the NIAID ordinal scale
Time frame: Daily up to Day 28
Proportion of subjects using continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)
Time frame: Randomization to Day 28
Proportion of subjects using high-flow nasal cannula (HFNC)
Time frame: Randomization to Day 28
Proportion of subjects using extracorporeal membrane oxygenation (ECMO)
Time frame: Randomization to Day 28
Maximum Change in Sequential Organ Failure Assessment (SOFA) score
Time frame: Randomization to Day 28
Change in SOFA score and in individual components of the SOFA score
Time frame: Baseline to Day 28
Number and proportion of subjects experiencing adverse events (AEs)
Time frame: Up to 60 days
Number and proportion of subjects experiencing serious adverse events (SAEs)
Time frame: Up to 60 days
Number and proportion of subjects experiencing adverse events of special interest (AESIs)
Time frame: Up to 60 days
Presence of anti-CSL324 antibodies
Time frame: Up to 28 days
Maximum concentration (Cmax) of CSL324
Time frame: Up to 28 days
Time to reach maximum concentration (Tmax) of CSL324
Time frame: Up to 28 days
Area under the concentration-time curve (AUC0-last) of CSL324
Time frame: Up to 28 days
Trough concentration (Ctrough) of CSL324
Time frame: Before dose on Day 4 and Day 8
No study locations are listed for this record.
Plan to share: Yes — CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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