A randomised double blind trial to evaluate the activity of formulation of Particle Life Sciences in the management of SARS-CoV-2 Infection.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Severity of disease in SARS-CoV-2.
研究概览
简要总结
**Objective of the Study:****Primary Objective:**The primary objective of the study is to evaluate the role of Particle Life Sciences Formulation in management of COVID-19.
Secondary Objective: Safety and tolerability; clinical variables.
N=100.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness.
- •Age more than 18 & less than 65 years of either sex.
- •Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8).
- •Respiratory rate is more than 20/min.
- •Pulse rate more than 90/min.
- •Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation.
排除标准
- •Pregnant women.
- •Breastfeeding women.
- •Requiring ICU admission at screening.
- •Patients above 65 years of age and below 18 Years.
- •Past History of MI, Epileptic episodes.
- •Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening.
- •Asymptomatic patients.
- •Patients unwilling for informed consent.
- •Patients with prolonged QTc interval on ECG.
- •In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •Participant with any immunosuppressive condition or hematological disease.
- •Participation in any other A.S.U and H protocol.
结局指标
主要结局
Severity of disease in SARS-CoV-2.
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study
Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/face.
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study
Serum levels of CRP, D-Dimer, Ferritin, IL-6 (At baseline and end of the study as per availability).
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study
Clinical status expressed in percentage of subjects based on Ordinal Scale for Clinical
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study
Improvement.
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study
Duration of symptoms in Patients of SARS-CoV-2 measured in days.
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study
次要结局
- Change in National Early Warning Score(Hematological parameters like WBC, Hb and platelet count etc.)