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

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: EUCTR2021-000320-35-CZ
• Lead Sponsor: Oxygen Biotech s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-04
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

• 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.

Study & Design

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