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CSL324 in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04519424
Recruitment Status : Withdrawn (Due to business reasons, not safety issues.)
First Posted : August 19, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE August 18, 2020
First Posted Date  ICMJE August 19, 2020
Last Update Posted Date October 14, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation [ Time Frame: Randomization to Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CSL324 in COVID-19
Official Title  ICMJE A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease 2019 (COVID-19)
Intervention  ICMJE
  • Biological: CSL324
    Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
  • Drug: Placebo
    Normal saline (0.9% sodium chloride)
Study Arms  ICMJE
  • Experimental: CSL324
    CSL324 administered intravenously
    Intervention: Biological: CSL324
  • Placebo Comparator: Placebo
    Normal saline administered intravenously
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 12, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2020)
124
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years at the time informed consent is obtained
  • Positive for SARS-CoV-2 infection determined by a diagnostic test approved by the Food and Drug Administration (FDA) or allowed under an emergency use authorization
  • Chest computed tomography (CT) scan or X ray results confirming interstitial pneumonia
  • Meets ≥ 1 of the following criteria (subjects improving while on respiratory support still qualify):

    • Respiratory rate > 30 breaths per minute
    • Peripheral (capillary) oxygen saturation (SpO2) ≤ 93% on room air
    • Partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) ratio (PaO2 / FiO2) < 300
    • SpO2 / FiO2 ratio < 218 (if PaO2 / FiO2 ratio is not available)
    • Radiographic lung infiltrates > 50%

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:

      • Administration of investigational product with emergency use authorization granted for treatment of COVID 19 (eg, remdesivir) is permitted
      • Convalescent plasma as part of approved special access programs such as expanded access, emergency IND, or compassionate use is permitted
  • Pregnant or breastfeeding (female subjects)
  • Intubated and requires mechanical ventilation (including ECMO) at time of randomization

    • Exception: use of HFNC oxygen and noninvasive ventilation are permitted
  • Endotracheal intubation is imminent, in the opinion of the investigator
  • Not expected to survive for more than 48 hours after hospital admission, in the opinion of the investigator
  • Presence of any of the following comorbid conditions before randomization and prior to SARS-CoV-2 infection:

    • New York Heart Association class IV heart failure
    • Stage 4 or 5 chronic kidney disease or requires renal replacement therapy
    • Biopsy proven cirrhosis, portal hypertension or hepatic encephalopathy
    • Stage IV malignancy
    • Chronic lung disease requiring home oxygen
    • Active tuberculosis
  • History or evidence of pulmonary alveolar proteinosis
  • Confirmed diagnosis or clinical suspicion of bacterial pneumonia or active uncontrolled bacterial, fungal, or non SARS-CoV-2 viral infection at Screening
  • Absolute neutrophil count (ANC) value < 5 × 109 cells/L at Screening (can be lowered up to < 1.5 × 109 cells/L after Independent Data Monitoring Committee review of safety data, if CSL324 induced neutropenia is not assessed as a safety concern)
  • Currently receiving a prohibited therapy including G-CSF, granulocyte-macrophage colony-stimulating factor (GM-CSF), or antibody against interleukin 6 (IL-6) / IL 6 receptor (anti IL-6 / 6R)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04519424
Other Study ID Numbers  ICMJE CSL324_COVID-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Access Criteria:

Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

Responsible Party CSL Behring
Study Sponsor  ICMJE CSL Behring
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CSL Behring
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP