EUCTR2020-005890-29-IT进行中（未招募）1 期
Comparative efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 patients on the reduction of the risk of disease worsening:A multi-stage multi-arm adaptive randomized cluster trial - Early Treatment of COVID-19 infection – The ETC study
FONDAZIONE RICERCA TRASLAZIONALE (FORT)0 个研究点目标入组 810 人开始时间: 2021年3月22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
- 810
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 from 35 to 80 years
- •2.Confirmed SARS-CoV-2 infection, (evidence of infection obtained by COVID-19 swab test prior to consent signing is accepted)
- •3.Patients with mild / moderate symptoms with at least fever and / or painful manifestations such as headache, muscle aches, sore throat, and in addition vomiting and/or diarrhea.
- •4.Signing informed consent
- •5.For female patients: statement of menopausal status or absence of pregnancy
- •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 570
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1.Age less than 35 years old
- •2.80 years old in the year of enrollment
- •3.Clinical condition requiring steroid therapy
- •4.Mechanical ventilation needed
- •5.Pregnancy and breastfeeding
- •6.Severe electrolyte imbalances
- •7.History of ventricular cardiac arrhythmias
- •8.Known renal insufficiency (CcCl <30 mL / min or patient on CCRT, haemodialysis or peritoneal dialysis)
- •9.Oncological, haemato-oncological, haematological and / or hepatic disease
- •10.Retinal disease, or hearing loss
- •11.Mental illness
- •12.Skin disorders (including skin rash, dermatitis, psoriasis)
- •13.Patients already on anticoagulant treatment with high / low molecular weight heparins or other parenteral anticoagulants
- •14.Patients at high venous thromboembolic risk according to the Padua score already on prophylaxis with low molecular weight heparin or unfractionated heparin
- •15. Patients with indications for treatment with oral anticoagulants
- •16.Patients on chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
- •17.Patients being treated with antivirals
- •18.Patients treated with monoclonal antibodies with direct action on cytokines
- •19.Patients being treated with chloroquine / hydroxychloroquine
- •20.Intolerance to study drugs
- •21.Immunosuppressive therapy in progress or in the last month.
- •22.Patients with severe hepatocellular insufficiency
- •23.Patients with ulcerative colitis or Crohn's disease
- •24.Patients with increased bleeding risk:
- •Congenital and acquired haemorrhagic diseases
- •Thrombocytopenia (<25,000 / mm3)
- •Bleeding in progress
- •Previous heparin thrombocytopenia
- •25.Women of childbearing age who do not use contraceptives
- •26.Participation in other interventional or observational clinical trials
研究者
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