Effect of short term inhaled Budesonide in children with mild COVID 19 infection an open labeled randomized controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effect on disease progression in children affected with COVID 19
研究概览
简要总结
Coronavirus Disease 2019 (COVID 19) has run a mild course in majority ofchildren. The second wave in India has been accompanied by a significantincrease in pediatric population, though the severity of the disease in thisage group has been milder than the adult counterpart till now. Research inpediatric COVID 19 treatment has been scarce mainly due to the benign course ofthe illness but this might not be the case with future mutation in the COVID 19which is part of the disease characteristics. In adults with pre-existingcondition like diabetes and hypertension or people above 60 years with milddisease, inhaled budesonide has been useful in preventing progression of thiscondition and has been found to be safe to use. With varied duration ofsymptoms noted with children even in a benign course, our open label randomizedcontrolled trial is looking into the use of budesonide as a therapeutic optionin preventing progression and reducing the time duration of associatedsymptoms.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of COVID 19 infection(COVID RT-PCR positive or HRCT suggestive of CORADS 4/5/6) Mild disease presenting within the first 7 days of illness.
排除标准
- •Children with moderate or severe COVID 19 infection at presentation.
- •Children with comorbidities on immunosuppressants or on steroids.
- •Parents or guardian not consenting to be part of the study.
结局指标
主要结局
Effect on disease progression in children affected with COVID 19
时间窗: 14 days
次要结局
- Effect on symptom control(14 days)