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临床试验/RPCEC00000337
RPCEC00000337已完成1 期

Intranasal administration of recombinant human interferon alfa-2b as prophylaxis of SARS-CoV-2 infection. (COVID-19)

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention

入排标准

年龄范围
19 years 至 one(—)
性别
All

入选标准

  • 1) Individuals aged = 19 years.
  • 2) Voluntariness of the subject by signing the informed consent.

排除标准

  • 1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2.
  • 2) Treatment with immunosuppressants in the last month prior to inclusion.
  • 3) Ongoing treatment, for any reason, with any IFN formulation.
  • 4) Acute illnesses in the last 30 days.
  • 5) Use of any other medication intranasally.
  • 6) Subjects who underwent tonsillectomy.
  • 7) History of allergic rhinitis and recurrent episodes of nasal bleeding.
  • 8) Active chronic asthma.
  • 9) Patients with myasthenia gravis.
  • 10) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion.
  • 11) Administration of an investigational drug in the 30 days prior to inclusion in the study.
  • 12) Known hypersensitivity to thiomersal and any of the components of the formulation under study.
  • 13) Pregnancy or breastfeeding.
  • 14) Obvious mental incapacity to issue consent and act accordingly with the study.

研究者

发起方
Center for Genetic Engineering and Biotechnology (CIGB), in Havana

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