EUCTR2020-003779-17-DE进行中（未招募）1 期
A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive inpatients with acute respiratory insufficiency (ARI)-COVARI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male / female / diverse adult =18 years of age at time of enrolment
- •2.Laboratory-confirmed SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test in any defined specimen prior to enrolment; samples of first positive test collected within 8 (for symptomatic patients at the time of test) respectively 14 (for asymptomatic patients at the time of test) calendar days prior to randomisation are accepted.
- •3.Inpatient admitted to an isolation ward with dyspnoea and / or tachypnoea (e.g. respiratory rate >20/minute) in stable conditions (i.e. without immediate plans for intermediate (IMC) or intensive care unit (ICU) transfer) and a need for supplemental oxygen with low-flow (i.e. up to 5 l/min) nasal cannula according to investigators assessment.
- •4.Signed informed consent and data protection declaration prior to initiation of any trial procedures
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Acute respiratory distress syndrome (ARDS) at time of inclusion2.
- •2.Relevant laboratory abnormality (serum liver enzymes (ASAT, ALAT, GGT) >3x upper range of normality)
- •3.Known hypersensitivity to trial medication or excipients
- •4.Presence of inflammatory gastrointestinal disease (e.g. Crohn´s Disease, or colitis ulcerosa, diverticulitis or non-infectious acute gastritis) at time of inclusion
- •5.Presence of acute or recurrent inflammatory disease of the gall bladder and / or biliary ducts at time of inclusion
- •6.Severe hepatic disease (e.g. liver cirrhosis Child Pugh B or C, ongoing viral hepatitis) at time of inclusion
- •7.Hereditary fructose intolerance
- •8.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 ml/min)
- •9.Only for female patients of childbearing potential: Pregnancy, positive urine pregnancy test on Day 1, breast feeding or no use of effective contraception
- •10.Active malignancy (active = running or immediately planned treatment options like e.g. surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 2 years without relapse, which would make it in the opinion of the investigator unsafe or unsuitable for the patient to participate in this clinical trial
- •11.Use of systemic immunosuppressants (except corticosteroids) within 4 weeks before inclusion into the clinical trial
- •12.Only for female subjects of childbearing potential: Woman who is pregnant or breast feeding, or without effective contraception
- •13.Patient in another clinical trial with an investigational medicianl product within 30 days before inclusion into the clinical trial
- •14.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)
- •15.Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
- •16.Patient in custody by juridical or official order evidence of an uncooperative attitude
- •17.Patient, who is a member of the staff of the study centre, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator
- •Note for exclusion criterion no. 10: Watchful waiting of prostate carcinoma is not considered as an active carcinoma provided that the patient is free of symptoms and without therapy regarding the prostate carcinoma. Such a constellation does not fulfil exclusion criterion no. 10. Final decision is at the discretion of the investigator.
研究者
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