COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04519424

CSL Behring

Not reported

2020-08-19

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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%

- 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)

2

CSL Behring

18

None

None

Severe disease at enrollment

6: Severe disease at enrollment

0

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

None

Phase 2

[{"arm_notes": "", "treatment_id": 359, "treatment_name": "Csl324", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]