Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- COVID-19 symptoms improvement
研究概览
简要总结
This study is aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.
详细描述
There is currently no specific early-stage therapeutic treatment available for COVID-19.
Vitamin D3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent.
The present study is aimed to investigate the treatment benefits of vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older, of either gender
- •Patients must be tested positive for SARS-CoV-2 by RT-PCR
- •Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
- •Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
- •Patients must be under the care of a Physician for diagnosis of COVID-19
- •Patients who have signed informed consent
排除标准
- •Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
- •Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
- •Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
- •Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
- •Patients with gallstone obstruction
- •Hypothyroid suppering patients
- •Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
- •Pregnant patients
研究组 & 干预措施
Standard of care
This arm will receive the standard of care as per the hospital guidelines.
干预措施: Standard of care (Drug)
Investigational treatment
This arm will receive vitamin D3 supplement as add-on to the standard of care.
干预措施: Standard of care (Drug)
Investigational treatment
This arm will receive vitamin D3 supplement as add-on to the standard of care.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
COVID-19 symptoms improvement
时间窗: From day 1 to day 14
The numbers of patients whose COVID-19 symptoms are subsided
SARS-CoV-2 Negativity by RT-PCR
时间窗: From day 1 to day 14
The numbers of patients that tests COVID-19 negative
次要结局
- Changes in CRP level(From day 1 to day 14)
- Changes in full blood count(From day 1 to day 14)
- Changes in D-dimer level(From day 1 to day 14)
- Changes in LDH level(From day 1 to day 14)
- Changes in ferritin level(From day 1 to day 14)
研究者
Dr Umer Farooq
Professor of Community Medicine
Ayub Teaching Hospital