COVID-19 patients suffering from moderate to severe pneumonia MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: BAZE-X1
Pharmaceutical Form: Concentrate for nebuliser solution
INN or Proposed INN: Bazedoxifene
CAS Number: 198481-32-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Oxygen Biotech s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women or men aged between 18 and 64; 2. Presence of COVID-19 pneumonia (Chest X-ray or CTPA evidence, as assessed by the treating physician); 3. Patient is admitted to hospital due to COVID-19 pneumonia; 4. Laboratory-confirmed SARS-CoV-2 infection (e.g., by PCR, antigen); 5. The patient's ability to cooperate and express his/her consent with the study participation; 6. Women of childbearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use highly effective contraceptive method from the day of enrollment in the study until 7 days (5 half-lives of bazedoxifene) after the last administered dose of IMP. As highly effective contraceptive method is considered: a. implantable intrauterine device (excluding hormone release system) b. bilateral tubal occlusion in females c. vasectomized male/partner d. sexual abstinence 7. Non-fertile man or fertile man who agree with sexual abstinence or using condom from the day of enrollment in the study until 7 days (5 half-lives of bazedoxifene) after the last administered dose of IMP; 8. Signed Informed Consent Form for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Need of mechanical pulmonary ventilation (invasive / non-invasive) at study entry; 2. Need of ECMO at study entry; 3. Known hypersensitivity to the active substance or excipients; 4. Pregnancy and breast-feeding; 5. Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illness, in whom participation in a clinical trial could pose an additional risk according to the investigator’s assessment; 6. Positive result on HIV, hepatitis A, B or C at screening; 7. Active tuberculosis infection at screening; 8. Known bacterial or fungal infection at screening; 9. Participation in another interventional treatment study with an investigational product within 30 days, or 5 half-lives, whichever is longer, prior to the planned first study treatment administration or use of other investigational product during this study; 10. Presence of hematological or generalized solid malignancy; 11. Presence of pulmonary embolism; 12. Hepatic impairment assessed individually by the investigator, ALT and/or AST levels = 5x ULN at screening and baseline; 13. On active therapy with IL-6R / IL-6 / JAK / IL-1R / IL-1 inhibitor; 14. Previous receipt of IL-6R / IL-6 / JAK / IL-1R / IL-1 targeted therapy within 30 days, or 5 half-lives, whichever is longer, prior to the planned first study treatment administration; 15. Treatment with convalescent plasma; 16. Absolute Neutrophil Count (ANC) less than 500/µl at screening and baseline; 17. Platelet count of less than 50 000/µl at screening and baseline; 18. History of any severe allergy affecting respiratory system; 19. Previous participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: To evaluate safety and tolerability of repeated dose of BAZE-X1 administered three times daily. Part B: To evaluate safety and tolerability of repeated dose of BAZE-X1 administered three times daily compared to placebo.;Secondary Objective: Part A: To assess efficacy of repeated dose of BAZE-X1 administered three times daily. To assess PK profile and efficacy of repeated dose of BAZE-X1 administered three times daily. Part B: To assess efficacy of repeated dose of BAZE-X1 administered three times daily.;Primary end point(s): Part A: Safety and tolerability of single dose level of BAZE-X1 administered three times daily in patients with COVID-19 pneumonia measured by incidence and spectrum of all adverse events. Part B: Safety and tolerability of single dose level of BAZE-X1 administered three times daily in patients with COVID-19 pneumonia measured by incidence and spectrum of all adverse events.;Timepoint(s) of evaluation of this end point: D28 (End of trial for the subject) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: Pharmacokinetic profile of BAZE-X1 measured by plasma concentrations at pre-dose before first and last administered dose and 10 minutes after first and last administered dose. Part A and B: Efficacy of BAZE-X1 on prevention of cytokine storm measured by change in leukocyte, lymphocyte, neutrophil count and plasma concentration of CRP, D/dimers, ferritin and IL-6 at EoT compared to baseline (D1). Efficacy of antiviral effect of BAZE-X1 measured by change in concentration of N (nucleocapsid) antigen in blood at EoT compared to baseline (D1). Efficacy of BAZE-X1 in patients with COVID-19 pneumonia measured by number of respiratory (invasive / non-invasive mechanical ventilation) and cardiovascular (infusion of vasopressor/inotrope at any dose) support free days within 28 days of study period, calculated from baseline (D1) to discharge or last follow-up (D28). Efficacy of BAZE-X1 measured by number of days on supplementary oxygen therapy (face mask up to 15 L/min) within 28 days of study period, calculated from baseline (D1) to discharge or last follow-up (D28). Efficacy of BAZE-X1 measured by number of days on HFNC (high-flow nasal cannula devices) within 28 days of study period, calculated from baseline (D1) to discharge or last follow-up (D28). Efficacy of BAZE-X1 in patients administered with oxygen (supplementary oxygen therapy or HFNC) at the baseline (D1) measured by the change in oxygen flow (L/min) at D28 or day of discontinuation of oxygen administration if earlier, compared to baseline (D1). Efficacy of BAZE-X1 measured by hospital discharge time within 28 days of study period, calculated from baseline (D1) to discharge or last follow-up (D28). Efficacy of BAZE-X1 measured by change in P/F ratio at EoT compared to baseline (D1). Hospital mortality at D28. Efficacy measured by changes in Clinical status of patient (using 7-point ordinal scale): at baseline (D1), EoT and D28. - Death - Hospitalized, on invasive mechanical ventil | — |
Countries
Czechia, Czech Republic, Slovakia
Contacts
Public ContactMUDr. Beata Cecetková, PhD.
TWMA, s.r.o.
Outcome results
None listed