EUCTR2020-003107-34-RO
进行中（未招募）
1 期
A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in Covid-19 pneumonia patients
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Adult subjects with Covid-19 pneumonia
- 发起方
- Shaperon Inc
- 入组人数
- 60
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female subjects \=18 years and \< 80 years.
- •2\. Laboratory\-confirmed SARS\-CoV\-2 infection by PCR for the
- •first time within 72 hours prior to randomization
- •3\. Diagnosis of pneumonia based on:
- •Radiographic infiltrates by imaging (chest x\-ray, CT scan) AND
- •3 of the following clinical symptoms: new onset cough, fever, fatigue, sputum (all day), tachypnea, dyspnea, pleuritic chest pain AND
- •CRP value \> 10 mg/L
- •4\. Patients with blood leukocyte count \> 4\.0 x 109 /L and lymphocyte count \> 0\.7 x 109 /L
- •5\. Patients with SpO2\=94% on room air or Pa02/FI02 ratio \<300mgHg at screening
- •6\. Patients capable to give consent and who have signed the informed consent form before any trial related assessment.
排除标准
- •1\. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
- •2\. Reduced renal function with estimated glomerular filtration rate (eGFR) \< 30 ml/min or
- •hemodialysis or hemofiltration.
- •3\. Pregnancy or breast feeding.
- •4\. Evidence of multiorgan failure
- •5\. Steroid treatment by any reason within 72 hours prior to enrolment
- •6\. Participation in any other clinical trial of an experimental agent treatment for COVID\-19
- •7\. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
结局指标
主要结局
未指定
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