跳至主要内容
临床试验/NCT05035524
NCT05035524Unknown不适用

A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19

Mansoura University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
340
试验地点
1
主要终点
The time interval to recovery defined as the first day

研究概览

简要总结

The aim of the study is to investigate the role of SB 8.4% as adjuvant therapy in the treatment of COVID- 19 patients proved to be RT-PCR positive (mild, moderate and severe).

详细描述

Corona virus disease 19 (COVID-19) is a rapidly spreading disease that involves almost every part of the world. Although numerous attempts are being carried out to prevent and treat the disease, there is no consensus about the gold standard treatment. In the recent study (El-Badrawy et al., 2021) our group published a controlled study investigating the role of inhalable sodium bicarbonate (SB) as adjuvant treatment of non-severe CT- identified COVID-19 pneumonia. The study concluded that sodium bicarbonate 8.4% inhalation with its nasal instillation could be a possible adjuvant therapy for patients with non-severe COVID-19 pneumonia. Nevertheless, our previous study suffers from some limitations being non randomized, with a small sample size and short duration of follow up. Moreover, the study included only moderate cases of COVID-19 and excluded mild and severe cases.

The present protocol is designed to avoid the limitations of our previous study in an attempt to obtain clear answer about the role of inhalable SB as an adjuvant treatment of COVID-19.

The emergence of new mutants of Corona virus is a new problem that can face the synthesized new anti COVID vaccines. The use of SB in treatment of COVID-19 may overcome Corona virus whatever its mutant variant.

We hypothize that SB may neutralize the effect of sialic acid through change of pH and change of the negative change, therefore prevent attachment, fusion and transport of the virus into the host cell.

Theory:

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

入选标准

  • all consecutive patients suspected as COVID-19 presented to the respiratory evaluation zone and outpatient clinic of our university will be subjected to RT-PCR test for COVID.
  • Patients proved to be RT-PCR positive will be included in the present study.

排除标准

  • pregnant ladies
  • who will refuse enrollment or discontinue follow up.

研究组 & 干预措施

Sodium Bicarbonate

Active Comparator

Adjuvant SB treatment Inhalation of SB 8.4% via a jet nebulizer (5 ml every 4 h) starting at 7:00 to 23:00 hours every day for 30 days together with instillation of SB 8.4% drops 4-times daily (three drops for each nostril) were offered to all patients in the study group

干预措施: Sodium Bicarbonate Solution (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

The time interval to recovery defined as the first day

时间窗: 1 months

assessed by subtracting the day of recovery from the day of infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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