severe pneumonia due to COVID-19 MedDRA version: 23.1 Level: PT Classification code 10084380 Term: COVID-19 pneumonia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: STC3141
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Grand Medical Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Males and non-pregnant females who are 18 years or older (inclusive). 2. Signed informed consent. Subjects are to provide informed consent prior to any study procedures being performed. Consent can be oral if a written consent cannot be expressed. Where it is not practicable to approach a subject highly dependent on medical care, or the subject is not capable of making such a decision, consent will be sought from the legal representative of the subject. Subjects enrolled in the study based on consent by the legal representative will be given the opportunity to provide written confirmatory consent when and if they become able to do so. If the subject declines to confirm consent, they will be withdrawn from the study at the point where they decline consent. 3. Virological diagnosis of SARS-CoV-2 infection (documentation of real-time PCR or equivalent within the last 7 days, positive results is available before screening) 4. Hospitalized due to clinical/chest image diagnosis of sever pneumonia. Severe pneumonia defined as either dyspnea, or SpO2 on room air at rest =93% or PaO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. Subjects who have renal impairment at screening, defined as an estimate glomerular filtration rate (eGFR) 1.3XULN. 7. Subjects who have Absolute Neutrophil Count (ANC) 1.5XULN. 10. Severe anaemia (haemoglobin < 7.0 g/dL). 11. Bleeding in the past 24 hours requiring blood transfusion. 12. Women who are pregnant or lactating at Screening or planning to conceive (self or partner) at any time during the study, including the follow-up period. 13. Subjects who have the following chronic organ dysfunction or immunosuppression: a. Heart: New York heart association cardiac function IV. b. Lung: severe lung diseases other than COVID-19 lead to home oxygen therapy. c. Kidneys: renal impairment requiring chronic dialysis d. Liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; the upper digestive tract hemorrhage caused by portal hypertension; or previous liver failure/hepatic encephalopathy/hepatic coma. e. Immune function: IV chemotherapy and radiotherapy within 4 weeks before screening or use of immunosuppressive medication within 2 weeks before screening including but not limited to: tacrolimus, cyclosporin, sirolimus, mycophenolate or azathioprine etc., or subjects with leukemia, lymphoma or acquired immunodeficiency syndrome [AIDS]. 14. Solid organ or bone marrow transplantation within 4 weeks. 15. The following conditions occurring within 4 weeks prior to screening: a. Acute pulmonary embolism b. Acute coronary syndrome such as myocardial infarction, unstable angina pectoris etc. 16. Known allergy to the active ingredient of STC3141 or its excipients (i.e., phosphate buffer). 17. The investigator consider participation in the study is not in the best interests of the subjects. 18. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the subject; affect study endpoints or decrease the chance of obtaining satisfactory data required to achieve the objectives of the study. 19. Any other severe or unstable medical condition that, in the opinion of the Investigator or Sponsor, could be expected to progress, recur, or change to such an extent that it could put the subject at special risk, or bias the assessment of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety of STC3141 in subjects with severe COVID-19 pneumonia;Secondary Objective: 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 will be evaluated.;Primary end point(s): To assess safety, the incidence of adverse events, treatment emergent adverse events and serious adverse events up to Day 30;Timepoint(s) of evaluation of this end point: up to day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: see separate end points;Secondary end point(s): - Changes of CRP, D-dimer, TBL, ALT, eGFR, aPTT, and LDH from baseline over time • Changes of PaO2/FiO2 ratio from baseline over time • Changes of PaO2/FiO2 ratio from baseline over time for subjects who are on invasive or non-invasive ventilator • Changes of SOFA score from baseline over time Changes of SOFA score components from baseline over time • Time to invasive mechanical ventilation • Time to independence from non-invasive mechanical ventilation • Time to independence from oxygen therapy • Duration of hospitalization • All-cause mortality rate on Day 30 • Subgroup analysis Exploratory Endpoints: • Changes from baseline in MPO (NETs), citrullinated histone (H3 in plasma) and IL-1b, IL-2, IL-6, IL-8/CXCL8, IL-10, IFN-?, TNF-a, IL-12/P70 | — |
Countries
Belgium
Contacts
Public ContactProject Manager Clinical Trials
TRIUM Clinical Consulting
Outcome results
None listed