跳至主要内容
临床试验/JPRN-jRCT2051200159
JPRN-jRCT2051200159招募中3 期

A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Aerosolized JH509 in Hospitalized Adult Patients with Mild to Moderate COVID 19

Shoji Hashimoto0 个研究点目标入组 385 人开始时间: 2021年3月19日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
385

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • 1.Written informed consent has been obtained from the participants with the age of over 20 years at the time of signing the informed consent.
  • 2.SARS-CoV-2 infection is diagnosed by RT-PCR within 72 hours before starting drug administration.
  • 3.Less than 6 days from onset of COVID-19 symptoms to starting the administration of the investigational drug. The symptoms are defined as one or more of the following: fever (37.5 or higher), respiratory symptoms (cough, shortness of breath, chest pain, sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain, diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms defined by investigators or physicians.
  • 4.Have at least one of the following findings.
  • Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% but more than 93%.
  • Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection

排除标准

  • 1.History of hypersensitivity to interferon or Novaferon or any excipients of interferon or Novaferon.
  • 2.Having received other antiviral treatments (Favipiravir, Remdesivir, interferon, etc.)
  • 3.CTCAE Grade 3 or higher liver dysfunction (ALT / AST> 5ULN) or renal dysfunction (eGFR <30 mL / min / 1.73 m2)
  • 4.Active infections or other medical conditions that contraindicate inhalation therapy

研究者

发起方
Shoji Hashimoto

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