EUCTR2020-005849-16-DE进行中（未招募）1 期
An 8-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 development in hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) - Kinarus COVID-19 Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Kinarus AG
- 入组人数
- 432
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. Diagnosis of COVID-19 confirmed by a positive test for SARS-CoV-2 RNA by RT PCR in a specimen from the upper respiratory tract, lower respiratory tract or expectorated sputum or by a positive rapid antigen test for SARS-CoV-2
- •2.Patients hospitalized due to symptomatic COVID-19 infection
- •a.with a WHO progression score of 4 presenting with at least one of the following co-morbidities: cardiac arrhythmia, arterial hypertension, coronary heart disease, adipositas, chronic renal disease, chronic hepatic disease, active cancer, asthma, COPD, , diabetes mellitus, history of cerebrovascular disease, autoimmune disease, immunosuppression or age > 60 years
- •b. with a WHO progression score of 5 with or without comorbidities
- •3. Patients being treated or having received off-label agents for COVID-19 (approved for another indication than COVID-19, such as dexamethasone or remdesivir) are eligible for the study
- •4. Adult male or female patients aged = 18 years
- •5. Females must have a negative pregnancy test or must be post-menopausal
- •6. Able to understand and willing to sign an IRB approved written informed consent document. For patients unable to understand and sign themselves, his/her legal representative will be informed and sings the informed consent document in countries where national law/regulations permit.
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 288
排除标准
- •1. Patients participating in another clinical trial with a new investigational drug or an investigational non-drug treatment
- •2. Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
- •3. Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP
- •4. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
- •5. Any use of CYP450 2C8 inducers (e.g. rifampicin)
- •6. Known or suspected active viral (including HIV, hepatitis B, hepatitis C), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
- •7. Pregnant or breastfeeding women
- •8. Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator
- •9. Liver enzyme elevation more than 3x above normal
- •10.Patients who are detained or committed to an institution by a law court or by legal authorities (subject is vulnerable, such as deprived of freedom)
研究者
相似试验
进行中（未招募）
1 期
An 8-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 development in hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)COVID-19 development in hospitalized patients infected with SARS-CoV-2MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862EUCTR2020-005849-16-BGKinarus AG432
进行中（未招募）
不适用
An 8-week study to evaluate the efficacy (blood pressure lowering effect) and safety of LCZ696 given alone and in combination with amlodipineEUCTR2013-001643-30-ESovartis Farmacéutica S. A1,386
进行中（未招募）
不适用
An 8-week study to evaluate the efficacy (blood pressure lowering effect) and safety of LCZ696 given alone and in combination with amlodipineEUCTR2013-001643-30-SKovartis Pharma Services AG1,386
招募中
不适用
A 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Saccaharum Officinalis wax alcohols(Policosanol) on improvement of blood cholesterolKCT0006606Wonkwang University. Iksan Korean Medicine Hospital80
尚未招募
不适用
Clinical trial to evaluate the efficacy and safety of GyejigaChulbu-tang on degenerative osteoarthritisDiseases of the musculo-skeletal system and connective tissueKCT0003124Wonkwang University, Gwangju Medical Center56