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

CSL Behring0 sitesSeptember 2020

ConditionsCoronavirus Disease 2019 (COVID-19)

InterventionsCSL324 Placebo

DrugsPlacebo

Overview

Phase: Phase 2
Intervention: CSL324
Conditions: Coronavirus Disease 2019 (COVID-19)
Sponsor: CSL Behring
Primary Endpoint: Proportion of subjects progressing to endotracheal intubation or death prior to endotracheal intubation
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2020

End Date

May 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSL Behring

Responsible Party

Sponsor

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:

Arms & Interventions

CSL324

CSL324 administered intravenously

Intervention: CSL324

Placebo

Normal saline administered intravenously

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Randomization to Day 28

Secondary Outcomes

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