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临床试验/CTRI/2020/09/028084
CTRI/2020/09/028084尚未招募不适用

Nasal Calcium Salts for Clearing Exhaled Bioaerosols in healthy volunteers and in asymptomatic and midly symptomatic SARS COV 2 patients

Bangalore Baptist Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Exhaled bioaerosol count (particles per liter of air)

研究概览

简要总结

This study aims to compare the effects of nasal mist calcium salts to normal saline (Simply Saline Nasal Spray) on exhaled bioaerosol count (particles per liter of air) in healthy patients .  Studies conducted by Dr. David Edwards (Harvard Engineering) and his collaborators demonstrate that inhalation of mixed solutions of calcium chloride and sodium chloride reduce exhaled bioaerosol count in both animal and human studies.  Respiratory droplets and aerosols are the suspected mode of transmission for SARS-CoV-2.

The Coronavirus disease 2019 (COVID-19) is an unprecedented pandemic which has led to millions being affected and thousands dying every day across the world, including India.  Airborne infectious disease including COVID 19 transmits through the air by particles we exhale during natural breathing, most of these particles are less than a single micron in size, and not effectively filtered by conventional face masks.  Cleaning our airways of these particles is a hygienic measure that complements the wearing of face masks, the washing of hands, and social distancing, and can be of particular value in our current COVID-19 pandemic. A new product developed by Harvard Professor of the Practice of Biomedical Engineering David A. Edwards claims to be able to provide a nearly 100% reduction in the particles present in exhaled air — thus reducing the potential transmission of SARS-CoV-2 both into, and out of, the lungs while breathing. These scientists were looking ways to address the need for a broad prophylactic and anti-contagion defence against respiratory viral and bacterial infections for the last 15 years, using salt compositions to amplify natural antimicrobial defences of the respiratory system by incorporating three ions, all of which are abundant in human tissues: calcium, sodium and chloride.

Initial studies showed promising benefits. Hypertonic calcium chloride and sodium chloride solution delivered to the respiratory system appears to have potential as both hygienic and therapeutic biodefense against airborne pathogens. Hygienically, these physiological salts coat the surfaces of airway lining fluid to diminish breakup and clear away the sub-micron bioaerosol droplets that are not effectively captured by masks. By potentially boosting natural immunological defences — strengthening the barrier function of the airway lining fluid and promoting the secretion of β-defensin 2 from nasal and bronchial epithelial tissues — these salts may also act therapeutically for antimicrobial prophylaxis or treatment. While our results suggest that calcium and sodium chloride salt combinations may be therapeutically useful against bacterial and viral infections including influenza, rhinovirus and pneumonia, the results point to an immediate hygienic value in the fight against any airborne infectious disease, including COVID-19, by cleaning the airways of the small airborne droplets that carry airborne infection.

We wanted to see the effectiveness of the same as it has the capability of rapid large-scale implementation. We propose to do two randomised control trials, the first one on apparently health volunteers to see whether the proposed intervention reduces the exhaled aerosol count (hygienic bio defence). In the second RCT, we would be looking for the therapeutic biodefence, the effect of the intervention on the SARS CoV 2 viral load.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
6.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Health care workers or the general public .
  • •Willing for nasal spray treatment Phase2: Asymptomatic or mild COVID case with a Positive nasopharyngeal swab for SARS-Cov-2 (RT-PCR) not more than two weeks.

排除标准

  • •Phase1: Any symptoms suggestive of SARS-Cov-2 Phase2: .
  • •Nasal spray administered less than 12 hours before the study .
  • •active treatment with medications with a known side effect of dry mouth .
  • •current or prior mucosal head and neck cancer treatment, .
  • •acute or chronic upper aerodigestive tract infection,.

结局指标

主要结局

Exhaled bioaerosol count (particles per liter of air)

时间窗: Exhaled bioaerosol count (particles per liter of air)@ 15,30,45 minutes and 1Hr

次要结局

  • Nasal irritation(Nasal irritation @ 15,30,45 minutes and 1Hr)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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