Multi-center, randomized, parallel-group, comparative, open-label study to evaluate the efficacy and safety of Lupin’s Ayurvedic Nasal Spray in subjects diagnosed with COVID-19 and household contacts
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- 1. Change in SARS-CoV-2 viral load from baseline to day 2, day 4, day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group.
研究概览
简要总结
A multi-center, randomized, parallel-group, comparative, open-label study was conducted to evaluate the efficacy and safety of Lupin’s Ayurvedic Nasal Spray in subjects diagnosed with COVID-19 and household contacts. The study was carried out at 6 centers in India. All enrolled subjects were divided into 2 groups as per computer generated randomization list i.e. treatment group and prevention group. Subjects suffering from mild symptoms of newly discovered coronavirus disease (COVID-19) were enrolled in treatment group. Subjects who were household contacts with patients of newly discovered coronavirus disease and tested negative were included in the prevention group. Subjects from treatment group were randomly allocated (in 2:1 ratio) to either active treatment arm i.e. Lupin’s Ayurvedic Nasal Spray and Standard of care (SOC) or control arm i.e. Control nasal spray (saline nasal spray) and SOC. SOC was provided as per the applicable guidelines of ICMR/Local Health Authority and as per investigator’s discretion. All enrolled subjects allocated to receive Lupin’s Ayurvedic Nasal Spray were administered with Lupin’s Ayurvedic Nasal Spray, one spray per nostril for 5 times a day for 14 days. All enrolled subjects allocated to receive Control nasal spray (saline nasal spray) were administered with Control nasal spray (saline nasal spray), one spray per nostril for 5 times a day for 14 days.
Subjects from preventive group were randomly allocated (in 2:1 ratio) to either active treatment arm i.e. Lupin’s Ayurvedic Nasal Spray and SOC/standard preventive measures or control arm i.e. Control nasal spray (saline nasal spray) and SOC/standard preventive measures. All enrolled subjects allocated to receive Lupin’s Ayurvedic Nasal Spray were administered with Lupin’s Ayurvedic Nasal Spray, one spray per nostril for 3 times a day for 14 days. All enrolled subjects allocated to receive Control nasal spray (saline nasal spray) were administered with Control nasal spray (saline nasal spray), one spray per nostril for 3 times a day for 14 days
The primary objectives of the study were to assess change in SARS-CoV-2 viral load from baseline to day 2, day 4, day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group and proportion of subjects with viral negativity measured by RT-PCR on day 14 in prevention group. The secondary objectives were to assess number of days required for complete clinical recovery and proportion of patients with complete clinical recovery and safety and tolerability in terms of adverse events, serious adverse events on screening visit (Up to 5 days), baseline visit (Day 0), telephonic follow up (Day 2 to day 6), Day 7, telephonic follow up (Day 8 to Day 13) and day 14.
Results:
This study conducted on an approved Ayurvedic Nasal Spray of Lupin (Noxguard) has been completed. There was a faster and significant reduction in the baseline viral load after treatment with Noxguard nasal spray in COVID-19 patients. Significantly higher proportion of patients treated with Noxguard achieved viral negativity (as measured by RT-PCR) by day 4 and 7 compared to patients treated with control (saline) nasal spray. None of the patients treated at home with Noxguard required hospitalization versus 12% of patients treated with control (saline) nasal spray. None of the close contacts of COVID-19 patients in the prevention cohort contracted infection after treatment with Noxguard versus 9.1% in control (saline) nasal spray group. Use of Noxguard nasal spray was found to be safe and well-tolerated for the treatment of COVID-19 patients and for post-exposure prophylaxis of close contacts of COVID-19 patients.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol.
- •Subjects with mild COVID-19 symptoms (only for Treatment Group).
- •Subjects with uncomplicated upper respiratory tract infection (without shortness of breath or hypoxia [normal saturation i.e. SpO2 levels ≥94%]), may have mild grade of fever (<1000 C), cough, sore throat, nasal congestion, malaise and headache.
- •Participants staying with COVID-19 subject in the same household (only for Prevention Group).
- •Participants who have tested positive for RT-PCR (for treatment group only) and negative for RT-PCR (for prevention group only) within 5 days of enrollment.
排除标准
- •Subjects with moderate to severe disease
- •Subjects requiring or likely requiring oxygen support in the opinion of investigator
- •Any clinical contraindications, as judged by the investigator
- •Pregnant or lactating females
- •Subjects who are currently hospitalized or need for hospitalization
- •Any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of alcoholism, HIV or any other serious medical illness).
结局指标
主要结局
1. Change in SARS-CoV-2 viral load from baseline to day 2, day 4, day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group.
时间窗: Screening Visit (Up to 5 days), Baseline Visit (Day 0), Day 2, Day 4, Day 7, and day 14.
2. Proportion of subjects with viral negativity measured by RT-PCR on day 14 in prevention group
时间窗: Screening Visit (Up to 5 days), Baseline Visit (Day 0), Day 2, Day 4, Day 7, and day 14.
次要结局
- 1.No of days required for complete clinical recovery and Proportion of patients with complete clinical recovery(2.Safety and tolerability in terms of adverse events, serious adverse events)