Ignite Creation Date:
2024-05-06 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05094596
Status:
UNKNOWN
Last Update Posted:
2021-10-26
First Post:
2021-10-21
Brief Title:
Effect of Montelukast Therapy on Clinical Course Pulmonary Function and Mortality in Patients With COVID-19
Sponsor:
Bugra Kerget
Organization:
Ataturk University
Study Overview
Official Title:
ATATURK UNİVERSITY
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pandemic is a medical term that has become a ubiquitous part of the global vocabulary over the last year Although pandemics have occurred throughout human history their sociocultural economic and psychological impact can leave lasting damage In the current COVID-19 pandemic more than 200 million confirmed cases of severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection have been reported to date While most people present with mild symptoms such as loss of taste and smell sore throat joint pain and headache it can cause serious morbidity and mortality especially in individuals over 65 years of age and those with comorbidities
Acute respiratory distress syndrome ARDS and macrophage activation syndrome MAS are among the main causes of morbidity and mortality in COVID-19 A contributing factor in the development of these clinical conditions is overproduction of proinflammatory cytokines primarily tumor necrosis factor alpha TNF-α interleukin-6 IL-6 IL-8 and IL-1β These cytokines cause increased leukocyte accumulation in the alveolar spaces and consequently an increase in reactive oxygen radicals and proteases which inevitably leads to capillary endothelial damage and alveolar epithelial damage
Montelukast is a potent cysteinyl leukotriene cysLT receptor antagonist with anti-inflammatory activity and has been proven to significantly suppress oxidative stress Moreover cysLTs also have an important role in the regulation of cytokine production Administration of high doses of montelukast reduces IL-4 IL-5 and IL-13 production by T helper 2 cells This effect makes it an important anti-inflammatory agent in the treatment of asthma In addition montelukast was shown to significantly inhibit bradykinin-induced tracheal smooth muscle contraction thus supporting an interaction between bradykinin and leukotriene mediators
In studies investigating the efficacy of cysLT for ARDS and MAS montelukast was found to increase interferon gamma IFN-γ production and significant decrease the production of proinflammatory cytokines such as IL-1β IL-6 and IL-8 in mice infected with respiratory syncytial virus In another study cysLT prevented neutrophil infiltration lung inflammation and oxidative stress and significantly decreased levels of TNF-α and IL-6 in both the lung parenchyma and bronchoalveolar lavage fluid in an animal model of ARDS induced by hemorrhagic shock
In this study the investigators aimed to investigate the effect of treatment with varying doses of montelukast as an adjunct to standard antiviral therapy on pulmonary function tests and clinical course in patients with COVID-19
Acute respiratory distress syndrome ARDS and macrophage activation syndrome MAS are among the main causes of morbidity and mortality in COVID-19 A contributing factor in the development of these clinical conditions is overproduction of proinflammatory cytokines primarily tumor necrosis factor alpha TNF-α interleukin-6 IL-6 IL-8 and IL-1β These cytokines cause increased leukocyte accumulation in the alveolar spaces and consequently an increase in reactive oxygen radicals and proteases which inevitably leads to capillary endothelial damage and alveolar epithelial damage
Montelukast is a potent cysteinyl leukotriene cysLT receptor antagonist with anti-inflammatory activity and has been proven to significantly suppress oxidative stress Moreover cysLTs also have an important role in the regulation of cytokine production Administration of high doses of montelukast reduces IL-4 IL-5 and IL-13 production by T helper 2 cells This effect makes it an important anti-inflammatory agent in the treatment of asthma In addition montelukast was shown to significantly inhibit bradykinin-induced tracheal smooth muscle contraction thus supporting an interaction between bradykinin and leukotriene mediators
In studies investigating the efficacy of cysLT for ARDS and MAS montelukast was found to increase interferon gamma IFN-γ production and significant decrease the production of proinflammatory cytokines such as IL-1β IL-6 and IL-8 in mice infected with respiratory syncytial virus In another study cysLT prevented neutrophil infiltration lung inflammation and oxidative stress and significantly decreased levels of TNF-α and IL-6 in both the lung parenchyma and bronchoalveolar lavage fluid in an animal model of ARDS induced by hemorrhagic shock
In this study the investigators aimed to investigate the effect of treatment with varying doses of montelukast as an adjunct to standard antiviral therapy on pulmonary function tests and clinical course in patients with COVID-19
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None