CSL324 in COVID-19

NCT04519424 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CSL324_COVID-19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Coronavirus Disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (1)

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

  Randomization to Day 28

Secondary Outcomes (18)

• Proportion of deaths from all causes

  Randomization to Day 28

• Proportion of subjects intubated

  Randomization to Day 28

• Median length of stay in hospital

  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

  Randomization to Day 28

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

  Daily up to Day 28

Study Arms (2)

CSL324

EXPERIMENTAL

CSL324 administered intravenously

Biological: CSL324

Placebo

PLACEBO COMPARATOR

Normal saline administered intravenously

Drug: Placebo

Interventions

CSL324 BIOLOGICAL

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

CSL324

Placebo DRUG

Normal saline (0.9% sodium chloride)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 19, 2020
• Study Start: September 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.