Study in patients hospitalized with moderate to severe COVID-19 pneumonia to establish safety and tolerability of bazedoxifene, concentrated solution for nebulisation (BAZE-X1).

Phase 1

• Conditions: COVID-19 patients suffering from moderate to severe pneumonia; MedDRA version: 20.0Level: PTClassification code 10035664Term: PneumoniaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-005247-78-CZ
• Lead Sponsor: Oxygen Biotech s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified