Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
研究概览
简要总结
Abstract Background: Clinicians in pulmonary critical care medicine and critical care medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3 (NLRP3).
Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3 inflammasome by dapsone must be responsible for its observed preventive effects, functioning as a competitor.
Methods:
Patients who were on standard COVID-19 therapy are also after obtaining off label uses and explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400 mg three times daily.
详细描述
We are investigating in prospective ongoing non-randomized case study effects of addition of dapsone 100-200 mg daily in addition to standardized recommended treatment versus a a cohort of patient admitted at our institution since October 2020 versus a group that only received standardized treatment. Our primary out comes are decrease in FIO2 requirement leading to discharge from hospital and decrease in over all mortality between group treated with only standardized recommended treat versus group with addition of dapsone and cimetadine.
An objective criteria of improvement, was used for effectiveness of therapy.
A. a reduction in the FIO2 requirement and
B. a decrease in the progression of hypoxia. We treated the patients with standard COVID-19 ARDS treatment with dapsone 100 mg to target NLRP3 inflammasomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All, PCR confirmed cases of COVID-19
排除标准
- •Only consenting consenting patients
研究组 & 干预措施
Intervention
干预措施: Dapsone 100 MG (Drug)
结局指标
主要结局
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
时间窗: 1 year
1. Decrease in overall mortality between groups treated with standardized recommended composite therapy for COVID-19 versus group of Standardized therapy plus addition of dapson and cimedatine
次要结局
未报告次要终点
研究者
Badar Kanwar
Principal Investigator
Hunt Regional Medical Center