COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005247-78/CZ

TWMA, s.r.o. - MUDr. Beata Čečetková, PhD.

beata.cecetkova@twma.cz

2021-12-15

Completed

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

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.

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.

2

Oxygen Biotech s.r.o.

18

65

Czech Republic

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

9

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.

Declared number of arm (4.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 2181, "treatment_name": "Bazedoxifene", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]