Potential of FX06 to prevent disease progression in hospitalised nonintubated COVID-19 patients (Ixion) - IXIO

F4Pharma GmbH i.G.0 个研究点目标入组 306 人开始时间: 2022年7月23日最近更新: 2023年12月19日

适应症

试验速览

暂无简介。

•1. SARS-CoV-2 infection confirmed by PCR test
•2. Hospitalised patients
•3. WHO score 4-6 [28]
•4. Oxygen saturation = 92% under room air
•5. Breathing frequency per minute = 20
•6. Patients = 18 years
•7. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient
•8. Willingness to comply to study procedures and study protocol
•9. Patients able to understand the requirements of the study and give written informed consent
•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 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•1. Significant underlying known co-morbidities or conditions, defined as: o Other severe advanced or chronic lung diseases (e.g., COPD Gold = III, severe silicosis)
•o End-stage chronic kidney disease (stage 5)
•o End-stage chronic heart failure (NYHA = III)
•o Baseline neurologic disease which would preclude rehabilitation potential
•o Disseminated and/or metastasised malignancy
•o Severe deconditioning with a life expectancy of less than 6 months according to the treating physician
•o Immunocompromised patients
•- recipient of a solid organ transplant
•- regular intake of anti-inflammatory therapy due to concomitant auto- immune diseases (e.g., biologics)
•- primary immune deficiency
•2. Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient's safety and with the study outcome as judged by the treating physician
•3. Women pregnant or breastfeeding
•4. Males or females of reproductive potential not willing to use effective contraception for the duration of the study period (defined as PEARL index <1 - e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal occlusion or male partner with vasectomy; also see chapter 19.2 for guidance)
•5. Current participation in another interventional clinical trial with IMP or participation within the last 30 days

发起方

F4Pharma GmbH i.G.