EUCTR2020-001413-20-ES进行中（未招募）1 期
Phase 2, randomized, open-label study to compare the efficacy and safety of siltuximab vs. corticosteroids in hospitalized patients with COVID19 pneumonia
Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 100 人开始时间: 2020年4月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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. Age = 18 years old.
- •2. Hospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements:
- •a) Non-critical patient with pneumonia in radiological progression and / or
- •b) Patient with progressive respiratory failure at the last 24-48 hours.
- •3. Laboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center.
- •4. Patient with a maximum O2 support of 35%
- •5. Be willing and able to comply with the study related procedures / evaluations.
- •6. Women of childbearing potential * should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence).
- •7. Written informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.
- •When circumstances so allow, participants should sign the consent form.
- •The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained.
- •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 100
排除标准
- •1. Patient who, in the investigator's opinion, is unlikely to survive> 48 hours after the inclusion in the study.
- •2. Presence of any of the following abnormal analytical values at the time of the inclusion in the study:
- •- absolute neutrophil count (RAN) less than 2000 / mm3;
- •- AST or ALT> 5 times the ULN;
- •- platelets <50,000 per mm3.
- •3. In active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day.
- •4. Known active tuberculosis (TB) or known history of TB uncompleted treatment.
- •5. Patients with active systemic bacterial and / or fungal infections.
- •6. Participants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures.
- •7. Patients who do not have entry criteria in the Intensive Care Unit.
- •8. Pregnancy or lactation.
- •9. Known hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).
研究者
相似试验
进行中（未招募）
1 期
Randomised, open-label phase II study to compare the safety and efficacy of lapatinib plus trastuzumab or lapatinib plus capecitabine in trastuzumab-resistant HER2-overexpressing metastatic breast cancerEUCTR2012-000598-22-DEBerufsverband der niedergelassenen gynäkologischen Onkologen in Deutschland e.V.; BNGO e.V.100
进行中（未招募）
不适用
Efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neo-adjuvant treatmentEUCTR2012-003330-16-DEGBG Forschungs GmbH (German Breast Group)
招募中
2 期
A phase II, randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-androgen therapy (AAT) with apalutamide in patients with biochemical progression after radical prostatectomyProstate cancer2024-512023-37-00Ziekenhuis Aan De Stroom202
进行中（未招募）
1 期
A phase II, randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-androgen therapy (AAT) with apalutamide in patients with biochemical progression after radical prostatectomyMedDRA version: 20.0Level: LLTClassification code: 10007113Term: Cancer of prostate Class: 10029104Prostate cancerCTIS2024-512023-37-00GasthuisZusters Antwerpen202
进行中（未招募）
不适用
Randomized, open-label phase II study evaluating the safety and efficacy of Cetuximab plus modified FOLFOX - 6 versus modified FOLFOX - 6 alone as 2nd line therapy after progression on the 1st line treatment with Cetuximab + FOLFIRI in patients with metastatic colorectal cancer KRAS wild-type – TAGUS Study - TAGUS StudyEUCTR2008-008282-36-PTGrupo de Investigação do Cancro Digestivo