EUCTR2021-002009-85-BG进行中（未招募）1 期
Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Hospitalized subjects 18 to 85 years of age, inclusive
- •2. Able and willing to sign informed consent
- •3. Molecular (RT-PCR) diagnosis of SARS-CoV-2 infection
- •4. Moderate or Severe illness per NIH COVID-19 Treatment Guidelines:
- •Moderate” Illness: Symptoms such as cough, fever, sore throat, malaise, myalgias, headache; and Evidence of lower respiratory tract disease by clinical assessment and/or imaging; and SpO2 >93% on room air at sea level
- •Severe” Illness, including any of the following: Respiratory rate >30 breaths/minute; or SpO2 =93% on room air at sea level; or Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300; or Lung infiltrates >50% of pulmonary volume on imaging
- •5. Female subjects must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of investigational product.
- •6. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female subjects of childbearing potential are all those except subjects who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
- •a. For females: 2 of the following contraceptive methods, with at least 1 being a barrier method:
- •- Hormonal contraceptives for = 27 days before dosing
- •- Intrauterine device (IUD) in place = 27 days before dosing
- •- Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening
- •- Surgical sterilization of the partner (vasectomy = 1 month before screening)
- •- Female subjects must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of investigational product.
- •b. For males:
- •Surgical sterilization (vasectomy = 1 month before screening)
- •Both of the following contraceptive methods from screening:
- •- Consistently and correctly use a condom
- •- Partner must use a hormonal contraceptive or a nonhormonal barrier method (IUD or diaphragm with spermicide or cervical cap with spermicide).
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Critical” Illness, per NIH COVID-19 Treatment Guidelines, including any of the following: Respiratory failure; or Septic shock; or Multiple organ dysfunction
- •2. Participation in another clinical trial concurrently
- •3. Subjects who require mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- •4. Concurrent treatment with immunomodulators or anti-rejection drugs
- •5. Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- •6. History of any of the following diseases or conditions:
- •- Advanced or decompensated liver disease (including presence or history of bleeding varices, ascites, encephalopathy, or hepato-renal syndrome)
- •- Inability to swallow tablets, or gastrointestinal disease which could interfere with the absorption of piclidenoson
- •- Any malignancy within 5 years before screening; exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent)
- •- Cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder
- •- QTcF interval on an average of triplicate ECGs >450 milliseconds (msec) for males or >470 msec for females (except when QT prolongation is associated with right or left bundle branch block, in which case enrollment is allowed)
- •- Any condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, congenital Long QT Syndrome
- •- Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades de Pointes (https://crediblemeds.org/) unless the subject can be screened and monitored under the guidelines proposed by Giudicessi (2020)
- •-Pancreatitis
- •-Severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse
- •- Active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication
- •- Bone marrow or solid organ transplantation
- •- Any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed
- •7. Any of the following abnormal laboratory tests: Platelet count <90,000 cells/mm3 Absolute neutrophil count (ANC) <1,500 cells/mm3 Estimated creatinine clearance (CrCl) <50 mL/min by Cockcroft-Gault formulation Bilirubin level =2.5 mg/dL unless due to Gilbert’s syndrome AST or ALT level =3X the upper limit of normal Serum albumin level <3.0 g/dL International normalized ratio (INR) =1.5 (except subjects maintained on anticoagulant medications)
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 YearsThe test is a vaccine. The subjects are healthy adolescents.MedDRA version: 14.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2008-007789-51-PLPfizer Inc715
进行中（未招募）
不适用
A clinical study to test the safety and immune response of a vaccine against a bacteria causing meningitis B at doses of 60 µg, 120 µg, and 200 µg in healthy adolescents aged 11 to 18 YearsPrevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.MedDRA version: 17.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862EUCTR2008-007789-51-Outside-EU/EEAWyeth Research Division of Wyeth Pharmaceuticals Inc.539
进行中（未招募）
1 期
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT ChemotherapyFollowed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN)Histologically documented gastric or gastroesophageal junction adenocarcinoma withresectable disease (Stage II or higher per AJCC 8th edition).MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-001555-40-DEAstraZeneca AB900
进行中（未招募）
1 期
A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune ThrombocytopeniaEUCTR2016-003038-26-HUArgenx BVBA36
进行中（未招募）
1 期
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282