EUCTR2020-001618-39-ES进行中（未招募）1 期
A Phase II, randomized, open–label study to evaluate the efficacy and tolerability of treatment with vafidemstat in combination with standard of care treatment to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with COVID-19.
Oryzon Genomics S. A.0 个研究点目标入组 40 人开始时间: 2020年4月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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) Adult, age >=18 years
- •2) Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples, no more than 72h before randomization to study treatment
- •3) Patients admitted to hospital ward and at risk of ADRS or respiratory failure which will require mechanical ventilation
- •4) Severity of symptoms 3-4 according to WHO 7-point Global Overall Symptom scale (measures severity symptoms in clinical trials)
- •- Severity 3 – Hospitalized NO requiring supplemental oxygen
- •- Severity 4 - Hospitalized requiring supplemental oxygen
- •5) Confirmed CoVID-19 pneumonia diagnosis/bilateral pulmonary infiltrate of any severity, with = 72h duration and meeting at least one of the following criteria for severe condition:
- •- X-Ray progression (Pulmonary X-Ray with increased extension or increased number of infiltrates at control)
- •- IL-6 elevation
- •- Increase in at least one of the following systemic and pulmonary inflammatory biomarkers:
- •- D-dimer >1000 µg/L
- •- PCR > 5 mg/dL
- •- LDH >300 UI/L
- •- Ferritin >200 ng/mL
- •- Total Lymphocytes <1000 /mL
- •6) Ideally, treatment can be started no more than 5-7 days since the onset of symptoms
- •7) Sign the Informed Consent Form on a voluntary basis
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Platelets <150000/mm3
- •2) Neutrophils <1500/mm3
- •3) Mechanical ventilation that prevents administration of vafidemstat oral treatment
- •4) Investigator considers patient unsuitable
- •5) Women who are pregnant or breast-feeding (*)
- •*Fertile male and female must use highly efficient contraception until 30 days after last dose of the study treatment, defined as:
- •- A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner)
- •- The use of two methods of contraception [(one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive (e.g., combined oral contraceptives, patch, vaginal ring, injectable and implants)]
研究者
相似试验
尚未招募
2 期
A study to evaluate the effectiveness of a new chemotherapy regimen for breast cancer comparing to the standard chemotherapy.CTRI/2023/05/052756CMC Vellore
进行中（未招募）
2 期
A study to evaluate preventive treatments for talquetamab-related oral toxicityMultiple myelomaCancerISRCTN72589181Janssen-Cilag International NV120
进行中（未招募）
1 期
A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks. - FLU D-PAN H1N1-012Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.EUCTR2009-015174-35-NOGlaxoSmithKline Biologicals
进行中（未招募）
不适用
A randomized, open-label phase II. study evaluating the efficacy and safety of FOLFOX6+Cetuximab versus FOLFIRI+Cetuximab as first line therapy in patients with metastatic colorectal cancerfirst line therapy in patients with metastatic cancerEUCTR2004-002391-42-CZCECOG (Central European Cooperative Oncology Group)150
终止
2 期
Comparing a new combination of medicines to the normal standard of care chemotherapy treatment given to patients who have been recently diagnosed with acute myeloid leukaemiaCancerISRCTN71474257DIDACT Foundation164