A Randomized, Open label Study to Evaluate Efficacy and Safety of a Combination of Homeopathic Medications as an Add on Therapy to Standard of Care in Patients with Severe to Critical SAR-COV-2 (COVID-19) Infection
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- â—Patient clinical status (8-point ordinal scale) at Day 15.
研究概览
简要总结
This is a randomized, open-label, two-arm study of the combination of homoeopathic medications as add-on therapy in patients with severe to critical COVID-19 infection being conducted at AIIMS Bhopal. The objective of this study is to assess the efficacy and safety of a homoeopathic medication combination as add-on therapy in severe COVID 19 patients, as assessed by the Clinical Severity-Ordinal scale, the National Early Warning Score (NEWS), oxygenation, mechanical ventilation, hospitalisation, and mortality. Additionally, to assess changes in inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- •2.Male and female subjects greater than 18 years of age.
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR, Rapid Antigen Test, CBNAAT or CT suggestive of Pneumonia (CO-RADS 5 grade).
- •Adult with radiological signs of pneumonia (chest x-ray, CT scan, etc.) plus one of the following.
- •a.respiratory rate >30 breaths/min, b.severe respiratory distress, c.SpO2 <90% on room air.
- •d.With/without Oxygenation impairment: (Mild ARDS: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg (with PEEP or CPAP ≥5 cm H2O); Moderate ARDS: 100 mmHg < PaO2/FiO2 ≤200 mmHg with PEEP ≥5 cm H2O); Severe ARDS: PaO2/FiO2 ≤ 100 mmHg with PEEP ≥5 cm H2O) 5.Patient with or without pre-existing significant co-morbidities (e.g. lung diseases, diabetes, hypertension) at the discretion of the investigator.
- •6.Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods.
- •7.Willingness and ability to comply with trial and follow-up procedures.
- •8.Ability to understand the nature of the trial and give written informed consent.
排除标准
- •1.Patient with mild-moderate COVID-19 infection 2.Patients who are allergic to arsenic album products 3.Severely immunocompromised patients for example patients with a history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency.
- •4.ALT/AST > 5 times the upper limit of normal.
- •5.Stage 4 severe chronic kidney disease or requiring dialysis (eGFR <30 ml/min) 6.Subjects who is receiving Covid-19 directed alternative medication (e.g. Any ayurvedic, Unani or homeopathic) 7.Participation of patient in other investigational clinical studies 8.Pregnant or breastfeeding.
- •9.Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would in the opinion of investigator, pose an unacceptable risk to the subject in this study.
- •10.Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
- •11.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
结局指标
主要结局
â—Patient clinical status (8-point ordinal scale) at Day 15.
时间窗: at day 15
1.Death
时间窗: at day 15
4.Hospitalized, requiring supplemental oxygen
时间窗: at day 15
7.Not hospitalized, limitation on activities and/or requiring home oxygen
时间窗: at day 15
2.Hospitalized, on invasive mechanical ventilation or ECMO
时间窗: at day 15
3.Hospitalized, on non-invasive ventilation or high flow oxygen devices
时间窗: at day 15
5.Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
时间窗: at day 15
6.Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
时间窗: at day 15
8.Not hospitalized, no limitations on activities
时间窗: at day 15
次要结局
- â—To assess the Clinical Severity:(1.Ordinal scale:)
- â—Percentage change in the biomarkers such as IL-4, IL-6, CRP, ferritin, d-dimer and troponin C(on day 1,3,5,8 and 11)