Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Dyspnea
研究概览
简要总结
This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conscious consent to participate in the study
- •Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.
- •Strong clinical suspicion of covid 19 with positive findings in CT Scan
- •Shortness of breath
排除标准
- •Patients with HIV
- •Patients with cancer undergoing chemotherapy
- •Patients receiving Immune Mediators
- •Patients need hospitalization in the intensive care unit
- •Patients with uncontrolled heart, kidney or liver failure
- •Pregnant or lactating women
- •Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)
研究组 & 干预措施
Test Group
Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days.
干预措施: PHR160 Spray (Drug)
Test Group
Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days.
干预措施: Standard treatment (Drug)
Control Group
Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days
干预措施: Placebo (Drug)
Control Group
Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days
干预措施: Standard treatment (Drug)
结局指标
主要结局
Dyspnea
时间窗: up to 14 days
shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.
次要结局
- Mortality(Up to 28 days)
- Laboratory Treatment Response(up to 14 days)
- long of hospitalization(up to 28 days)
- Radiological Treatment Response(up to 14 days)
- O2 saturation without supplemental oxygen(up to 14 days)
- drug reactions Adverse(Up to 14 days)
- Allergic drug(up to 14 days)
研究者
Mohammad Sadegh Bagheri Baghdasht
Principal Investigator
Baqiyatallah Medical Sciences University