CSL324 in COVID-19

CSL Behring

Status and phase

Withdrawn

Phase 2

Conditions

Coronavirus Disease 2019 (COVID-19)

Treatments

Drug: Placebo

Biological: CSL324

Study type

Interventional

Funder types

Industry

Identifiers

NCT04519424

CSL324_COVID-19

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No 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)