The study is a Randomized, Open-Label, Multi-Centre, Phase 2a Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects with Severe Corona Virus Disease 2019(COVID-19)Pneumonia.
Pneumonia is the most frequent and serious complication of Corona Virus Disease 2019(COVID-19), a disease that results from severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection with a so-called "cytokine storm", characterized by the plasma increase of many cytokines that produce long-term damage and fibrosis of lung tissue. Therefore, the development of novel therapeutic strategies to target at neutrophils associated NETs/histones may reduce the overall disease mortality rate of COVID-19. STC3141 is a novel investigational product that can neutralize NETs/histone via charge-charge interaction. STC3141 was found to be well-tolerated in short infusions (2 hours) and continuous long-term infusions (72 hours) in healthy volunteers. A randomized, multi-centre, phase 2a study in 25 severe COVID-19 pneumonia subjects who require hospitalization, is designed to evaluate the safety and the preliminary effect of STC3141 in this population where the treatment will be tested for the first time. Subjects will be randomized to three cohorts in a 2:2:1 ratio to receive continuous infusion of STC3141 either at rate 58.3mg/hr or 87.5mg/hr up to 3 days (72hours), or to receive appropriate standard of care. All subjects in STC3141 treatment groups will also receive standard of care for their conditions as background treatment. The primary objective of the study is to evaluate the safety of STC3141 in subjects with severe COVID-19 pneumonia.The secondary objective is to evaluate the preliminary effects of STC3141 in the treatment of subjects with severe COVID-19 pneumonia.As an exploratory objective, the change in biomarkers from baseline following STC3141 treatment in subjects with severe COVID-19 pneumonia will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Onze-Lieve-Vrouwziekenhuis Aalst, VZW
Aalst, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Jan Yperman Ziekenhuis vzw
Ieper, Belgium
CHU Liège
Liège, Belgium
The incidence of adverse event(AE), treatment emergent adverse event(TEAE), serious adverse event(SAE), adverse event of special interest(AESI)
Time frame: up to 30 days
Changes of C-reactive protein(CRP)(mg/dL, or nmol/L, or mg/L)
Time frame: through study completion, an average of 30 days.
Changes of D-dimer(mg/L, or ng/mL, or μg/mL)
Time frame: through study completion, an average of 30 days.
Changes of total bleeding time(TBL)(μmol/L)
Time frame: through study completion, an average of 30 days.
Changes alanine transaminase(ALT)(IU/L, or U/L, or nkat/L)
Time frame: through study completion, an average of 30 days.
Changes estimated glomerular filtration rate(eGFR)(ml/min)
Time frame: through study completion, an average of 30 days.
Changes of activated partial thromboplastin time(aPTT)(seconds)
Time frame: through study completion, an average of 30 days.
Changes of lactate dehydrogenase(LDH)(IU/L, or U/L, or nkat/L)
Time frame: through study completion, an average of 30 days.
Changes of partial pressure of oxygen(PaO2)/fraction of inspired oxygen(FiO2) ratio
Time frame: through study completion, an average of 30 days.
Changes of partial pressure of oxygen(PaO2)/fraction of inspired oxygen(FiO2) ratio for subjects who are on invasive or non-invasive ventilator
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Time frame: through study completion, an average of 30 days.
Changes of Sequential Organ Failure Assessment(SOFA)score
Specific score of 0, 1, 2, 3, 4. Higher score indicates worse prognosis.
Time frame: through study completion, an average of 30 days.
Time to invasive mechanical ventilation
Time frame: through study completion, an average of 30 days.
Time to independence from non-invasive mechanical ventilation
Time frame: through study completion, an average of 30 days.
Time to independence from oxygen therapy
Time frame: through study completion, an average of 30 days.
Duration of hospitalization
Time frame: through study completion, an average of 30 days.
All-cause mortality rate
Time frame: On Day 30.
Subgroup analysis
Time frame: through study completion, an average of 30 days.