Pilot, open-label, monocentric study evaluating safety and clinical effect of application of NORMOSANG® in patients with COVID-19 disease

Thomayerova nemocnice0 个研究点目标入组 8 人开始时间: 2020年11月13日最近更新: 2020年11月30日

试验速览

暂无简介。

•Women or men aged 18 to 65 years;
•Laboratory-proven COVID-19 disease (SARS-CoV-2 proven PCR) from upper airway swabs
•Diseases with moderate clinical manifestations requiring hospitalization (eg fever, SpO2 = 93% presence of respiratory symptoms - eg cough, dyspnea and / or X-ray infiltrate findings), as assessed by the treating physician;
•Women of childbearing potential who may become pregnant must have a negative urine or blood pregnancy test at the initial visit and use an acceptable method of contraception for the duration of the study;
•(Acceptable methods of contraception include: barrier spermicide, oral, transdermal, injectable or implantable contraception, intrauterine device, abstinence, and surgical sterilization of the partner)
•Women who cannot become pregnant: after hysterectomy, bilateral oophorectomy, bilateral tubal ligation, are after menopause for at least 12 months or with proven infertility for any reason;
•The patient's ability to cooperate and sign the informed consent form
•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 for pulmonary ventilation at study entry;
•Known hypersensitivity to the active substance;
•Pregnancy and breast-feeding;
•Value of Fe2 +, ferritin, Hb, HCT (all above ULN);
•Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illnesses in whom participation in a clinical trial could pose an additional risk at the discretion of the study physician

发起方

Thomayerova nemocnice