Study to evaluate safety and efficacy of Bazedoxifene in addition to Standard of Care in hospitalized COVID-19 patients suffering from moderate to severe Pneumonia

Open label, monocentric pilot study to evaluate safety and efficacy of Bazedoxifene in addition to Standard of Care in hospitalized COVID-19 patients suffering from moderate to severe Pneumonia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000320-35-CZ

Enrollment

Registered

2021-02-04

Start date

2021-03-05

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: CONBRIZA 20 mg potahované tablety Product Name: CONBRIZA Product Code: EMEA/H/C/000913 Pharmaceutical Form: Tablet INN or Proposed INN: BAZEDOXIFENE ACETATE CAS Number: 198481-33-3 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women or men aged between 18 and 75 • Presence of COVID-19 Pneumonia (clinical manifestations and Xray or CT evidence, as assessed by the treating physician); • Patient is admitted to hospital due to moderate to severe symptoms of pneumonia as per investigator opinion. • Laboratory-confirmed SARS-CoV-2 infection (e.g., by PCR, antigen) within 14 days prior to randomization; • The patient's ability to cooperate and express his/her consent with the study participation; • Women of childbearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use highly effective contraceptive method that is: o combined (estrogen and progestogen containing) or progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) o implantable intrauterine device o intrauterine hormone-releasing system o bilateral tubal occlusion in females o vasectomized male/partner o sexual abstinence 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: • Need of pulmonary ventilation at study entry; • Need of ECMO at study entry • Known hypersensitivity to the active substance or excipients; • Pregnancy and breast-feeding; • 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 at the discretion of the study physician; • History or presence of coagulopathy, history of pulmonary embolism or severe thrombosis; • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was longer; • Malignancy; • Patient that is not able to swallow tablet.

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety of Bazedoxifene in patients with COVID-19 disease;Secondary Objective: 1.) Changes in Clinical status of patient (using 7-point ordinal scale): on Day 0, Day 5 and 21 - 28. a. Death b. Hospitalized, on invasive mechanical ventilation or ECMO c. Hospitalized, on non-invasive ventilation or high flow oxygen devices d. Hospitalized, requiring supplemental oxygen e. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) f. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical Care g. Not hospitalized 2.) Influence of patients' clinical condition (symptom score) between baseline and day 14 (or day of discharge) 3.) Monitoring the frequency of patients whose condition worsens into a critical state necessitating a ventilator; 4.) Time to normalization of chosen blood parameters; 5.) Length of hospital stay; 6.) Rate of virus elimination from HCD secretions; 7.) Occurrence of adverse events. ;Primary end point(s): Safety of Bazedoxifene in patients with COVID-19 disease;Timepoint(s) of evaluation of this end point: D28 (end of trial for the subject)	—

Measure

Time frame

Main Objective: Safety of Bazedoxifene in patients with COVID-19 disease;Secondary Objective: 1.) Changes in Clinical status of patient (using 7-point ordinal scale): on Day 0, Day 5 and 21 - 28. a. Death b. Hospitalized, on invasive mechanical ventilation or ECMO c. Hospitalized, on non-invasive ventilation or high flow oxygen devices d. Hospitalized, requiring supplemental oxygen e. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) f. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical Care g. Not hospitalized 2.) Influence of patients' clinical condition (symptom score) between baseline and day 14 (or day of discharge) 3.) Monitoring the frequency of patients whose condition worsens into a critical state necessitating a ventilator; 4.) Time to normalization of chosen blood parameters; 5.) Length of hospital stay; 6.) Rate of virus elimination from HCD secretions; 7.) Occurrence of adverse events. ;Primary end point(s): Safety of Bazedoxifene in patients with COVID-19 disease;Timepoint(s) of evaluation of this end point: D28 (end of trial for the subject)

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in Clinical status of patient (using 7-point ordinal scale) ;Timepoint(s) of evaluation of this end point: Day 0, Day 5 and 21 - 28.	—

Countries

Czech Republic

Contacts

Public ContactTomáš Pacák

Oxygen Biotech s.r.o.

admin@oxygenbiotech.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026