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CSL324 in COVID-19

Primary Purpose

Coronavirus Disease 2019 (COVID-19)

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

CSL324

Placebo

About this trial

This is an interventional treatment trial for Coronavirus Disease 2019 (COVID-19)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CSL324

Placebo

Arm Description

CSL324 administered intravenously

Normal saline administered intravenously

Outcomes

Primary Outcome Measures

Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation

Secondary Outcome Measures

Proportion of deaths from all causes

Proportion of subjects intubated

Median length of stay in hospital

Number and proportion of subjects with at least a 2-point improvement in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale

Number and proportion of subjects within each of the categories of the NIAID ordinal scale

Proportion of subjects using continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)

Proportion of subjects using high-flow nasal cannula (HFNC)

Proportion of subjects using extracorporeal membrane oxygenation (ECMO)

Maximum Change in Sequential Organ Failure Assessment (SOFA) score

Change in SOFA score and in individual components of the SOFA score

Number and proportion of subjects experiencing adverse events (AEs)

Number and proportion of subjects experiencing serious adverse events (SAEs)

Number and proportion of subjects experiencing adverse events of special interest (AESIs)

Presence of anti-CSL324 antibodies

Maximum concentration (Cmax) of CSL324

Time to reach maximum concentration (Tmax) of CSL324

Area under the concentration-time curve (AUC0-last) of CSL324

Trough concentration (Ctrough) of CSL324

Full Information

NCT ID

NCT04519424

First Posted

August 18, 2020

Last Updated

October 12, 2020

Sponsor

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT04519424

Brief Title

CSL324 in COVID-19

Official Title

A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Due to business reasons, not safety issues.

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease 2019 (COVID-19)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CSL324

Arm Type

Experimental

Arm Description

CSL324 administered intravenously

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline administered intravenously

Intervention Type

Biological

Intervention Name(s)

CSL324

Intervention Description

Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline (0.9% sodium chloride)

Primary Outcome Measure Information:

Title

Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation

Time Frame

Randomization to Day 28

Secondary Outcome Measure Information:

Title

Proportion of deaths from all causes

Time Frame

Randomization to Day 28

Title

Proportion of subjects intubated

Time Frame

Randomization to Day 28

Title

Median length of stay in hospital

Time Frame

Randomization to Day 28

Title

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

Title

Number and proportion of subjects within each of the categories of the NIAID ordinal scale

Time Frame

Daily up to Day 28

Title

Proportion of subjects using continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP)

Time Frame

Randomization to Day 28

Title

Proportion of subjects using high-flow nasal cannula (HFNC)

Time Frame

Randomization to Day 28

Title

Proportion of subjects using extracorporeal membrane oxygenation (ECMO)

Time Frame

Randomization to Day 28

Title

Maximum Change in Sequential Organ Failure Assessment (SOFA) score

Time Frame

Randomization to Day 28

Title

Change in SOFA score and in individual components of the SOFA score

Time Frame

Baseline to Day 28

Title

Number and proportion of subjects experiencing adverse events (AEs)

Time Frame

Up to 60 days

Title

Number and proportion of subjects experiencing serious adverse events (SAEs)

Time Frame

Up to 60 days

Title

Number and proportion of subjects experiencing adverse events of special interest (AESIs)

Time Frame

Up to 60 days

Title

Presence of anti-CSL324 antibodies

Time Frame

Up to 28 days

Title

Maximum concentration (Cmax) of CSL324

Time Frame

Up to 28 days

Title

Time to reach maximum concentration (Tmax) of CSL324

Time Frame

Up to 28 days

Title

Area under the concentration-time curve (AUC0-last) of CSL324

Time Frame

Up to 28 days

Title

Trough concentration (Ctrough) of CSL324

Time Frame

Before dose on Day 4 and Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing 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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CSL324 in COVID-19

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