Status:
WITHDRAWN
CSL324 in COVID-19
Lead Sponsor:
CSL Behring
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, admini...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04519424
Start Date
September 1 2020
End Date
May 1 2021
Last Update
October 14 2020
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