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

Oxygen Biotech s.r.o.0 个研究点目标入组 10 人开始时间: 2021年2月4日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Oxygen Biotech s.r.o.