Efficacy and safety of Tiprelestat for treatment of severe COVID-19 (COMCOVID trial) - COMCOVID trial

tiakis Biotech AG (formerly Proteo Biotech AG)0 个研究点目标入组 296 人开始时间: 2022年5月20日最近更新: 2024年6月3日

适应症

试验速览

暂无简介。

•1.Signed informed consent and data protection declaration prior to initiation of any trial procedures
•2.Patient =18 years of age at time of enrolment and capable of providing informed consent by him-/herself
•3.Patient with COVID-19 fulfilling the following criteria:
•a.First laboratory-confirmation of the current episode of SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test (no self-tests) in any defined specimen collected within 10 days prior to trial enrolment.
•b.Hospitalization for COVID-19 treatment
•c.without or with oxygen therapy by mask / nasal prong (score 4 or 5 according to WHO COVID-19 clinical progression scale)
•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 96
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1.Life time expectancy of 2 days or less as judged by the investigator
•2.Malignant disease requiring chemotherapy, radiation therapy and / or immune therapy at the time of enrolment
•3.Patient requiring dialysis
•4. [not applicable any more]
•5. Only for female patients of childbearing potential: Pregnancy, positive pregnancy test on Day 1, breast feeding or no effective contraception
•6.Current or previous participation within the past 30 days in another interventional clinical trial with an investigational product
•7.Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
•8.Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
•9.Patient in custody by juridical or official order evidence of an uncooperative attitude
•10.Patient, who is a member of the staff of the trial center, staff of the sponsor or contract research organization (CRO), the investigator him- / herself or close relatives of the investigator

发起方

tiakis Biotech AG (formerly Proteo Biotech AG)