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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Recruitment Status : Withdrawn (Due to business reasons, not safety issues.)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

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).


Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Biological: CSL324 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CSL324
CSL324 administered intravenously
Biological: CSL324
Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Placebo Comparator: Placebo
Normal saline administered intravenously
Drug: Placebo
Normal saline (0.9% sodium chloride)




Primary Outcome Measures :
  1. Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation [ Time Frame: Randomization to Day 28 ]

Secondary Outcome Measures :
  1. Proportion of deaths from all causes [ Time Frame: Randomization to Day 28 ]
  2. Proportion of subjects intubated [ Time Frame: Randomization to Day 28 ]
  3. Median length of stay in hospital [ Time Frame: Randomization to Day 28 ]
  4. 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 ]
  5. Number and proportion of subjects within each of the categories of the NIAID ordinal scale [ Time Frame: Daily up to Day 28 ]
  6. Proportion of subjects using continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) [ Time Frame: Randomization to Day 28 ]
  7. Proportion of subjects using high-flow nasal cannula (HFNC) [ Time Frame: Randomization to Day 28 ]
  8. Proportion of subjects using extracorporeal membrane oxygenation (ECMO) [ Time Frame: Randomization to Day 28 ]
  9. Maximum Change in Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Randomization to Day 28 ]
  10. Change in SOFA score and in individual components of the SOFA score [ Time Frame: Baseline to Day 28 ]
  11. Number and proportion of subjects experiencing adverse events (AEs) [ Time Frame: Up to 60 days ]
  12. Number and proportion of subjects experiencing serious adverse events (SAEs) [ Time Frame: Up to 60 days ]
  13. Number and proportion of subjects experiencing adverse events of special interest (AESIs) [ Time Frame: Up to 60 days ]
  14. Presence of anti-CSL324 antibodies [ Time Frame: Up to 28 days ]
  15. Maximum concentration (Cmax) of CSL324 [ Time Frame: Up to 28 days ]
  16. Time to reach maximum concentration (Tmax) of CSL324 [ Time Frame: Up to 28 days ]
  17. Area under the concentration-time curve (AUC0-last) of CSL324 [ Time Frame: Up to 28 days ]
  18. Trough concentration (Ctrough) of CSL324 [ Time Frame: Before dose on Day 4 and Day 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04519424    
Other Study ID Numbers: CSL324_COVID-19
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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
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.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases