跳至主要内容
临床试验/NCT04466280
NCT04466280撤回不适用

Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19 Disease in Healthcare Providers at Baqiyatallah Hospital in Tehran

Baqiyatallah Medical Sciences University1 个研究点 分布在 1 个国家开始时间: 2020年8月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
PCR test

研究概览

简要总结

180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours.

At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Negative PCR testing through throat swabs
  • Signing Conscious Consent

排除标准

  • History of ocular complications and visual disturbances
  • Sensitivity to plant compounds in the product

研究组 & 干预措施

Control Group

Active Comparator

Participants in this group use personal protective equipment in the face of patients with COVID-19

干预措施: Personal protective equipment (Device)

Intervention Group 1

Experimental

In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.

干预措施: Hydroxychloroquine (Drug)

Intervention Group 1

Experimental

In this group, participants will receive 200 mg of hydroxychloroquine tablets daily in addition to personal protective equipment.

干预措施: Personal protective equipment (Device)

Intervention Group 2

Experimental

In this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.

干预措施: Mucodentol (Drug)

Intervention Group 2

Experimental

In this group, participants, while observing and using complete personal protective equipment, will apply a thin layer of Dentol gel to the vestibular area of the mouth daily, every 6 to 8 hours.

干预措施: Personal protective equipment (Device)

结局指标

主要结局

PCR test

时间窗: up to 1 month

Laboratory PCR testing can help diagnose the disease

次要结局

  • Laboratory Treatment Response(up to 1 month)
  • drug reactions Adverse(up to 1 month)
  • Allergic drug(up to 1 month)
  • Radiological Treatment Response(up to 1 month)

研究者

发起方
Baqiyatallah Medical Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Sadegh Bagheri Baghdasht

Principal Investigator

Baqiyatallah Medical Sciences University

研究点 (1)

Loading locations...

相似试验