Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05157204 |
| Other study ID # |
saudia arabia |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2022 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Ministry of Health, Saudi Arabia |
| Contact |
Amr Ahmed |
| Phone |
+966597310032 |
| Email |
drmedahmed[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
COVID-19 has emerged as a global pandemic. It is mainly manifested as pneumonia which may
deteriorate into severe respiratory failure. The major hallmark of the disease is the
systemic inflammatory immune response characterized by Cytokine Storm (CS). CS is marked by
elevated levels of inflammatory cytokines, mainly interleukin-6 (IL-6), IL-8, IL-10, tumour
necrosis factor-α (TNF-α) and interferon-γ (IFN-γ). Of these, IL-6 is found to be
significantly associated with higher mortality. IL-6 is also a robust marker for predicting
disease prognosis and deterioration of clinical profile. (1) IL-6 was detectable in the
breath condensate of all the healthy non-smokers, but was significantly higher in the COPD
patient. Exhaled breath condensate is totally non-invasive and highly acceptable to patients.
The collection procedure has no effect on airway function or inflammation, and there is
growing evidence that abnormalities in condensate composition may reflect biochemical changes
in airway lining fluid. This method has been successfully used in previous studies to
investigate several inflammatory markers in COPD and asthmatic patients. (2) Il-6 is produced
in the lung by interstitial fibroblasts, alveolar macrophages, and large-vessel and bronchial
epithelial cells. IL-6 levels are high in chronic inflammatory conditions of the lung, such
as those due to allogeneic transplantation, bleomycin-induced fibrosis and a variety of human
interstitial lung diseases. High levels of IL-6 have been found in the induced sputum of
patients with COPD, particularly during exacerbation. Park et al. found increased IL-6 levels
in the Bronchioalveolar lavage fluid of patients with non-specific interstitial
pneumonia/fibrosis and in some patients with interstitial pneumonia. (3) the study involved
20 healthy controls and 20 patients with moderate to severe covid-19 according to cdc
classifaction and 20 patients post covid-19 with lung fibrosis to estimate the measurment of
interleukin-6 at exhaled condensate, this clinical randomized control study consists of 3
arms for 6 month ( all participants above 18 years non prgnant humans )
Description:
COVID-19 has emerged as a global pandemic. It is mainly manifested as pneumonia which may
deteriorate into severe respiratory failure. The major hallmark of the disease is the
systemic inflammatory immune response characterized by Cytokine Storm (CS). CS is marked by
elevated levels of inflammatory cytokines, mainly interleukin-6 (IL-6), IL-8, IL-10, tumour
necrosis factor-α (TNF-α) and interferon-γ (IFN-γ). Of these, IL-6 is found to be
significantly associated with higher mortality. IL-6 is also a robust marker for predicting
disease prognosis and deterioration of clinical profile. (1) IL-6 was detectable in the
breath condensate of all the healthy non-smokers, but was significantly higher in the COPD
patient. Exhaled breath condensate is totally non-invasive and highly acceptable to patients.
The collection procedure has no effect on airway function or inflammation, and there is
growing evidence that abnormalities in condensate composition may reflect biochemical changes
in airway lining fluid. This method has been successfully used in previous studies to
investigate several inflammatory markers in COPD and asthmatic patients. (2) Il-6 is produced
in the lung by interstitial fibroblasts, alveolar macrophages, and large-vessel and bronchial
epithelial cells. IL-6 levels are high in chronic inflammatory conditions of the lung, such
as those due to allogeneic transplantation, bleomycin-induced fibrosis and a variety of human
interstitial lung diseases. High levels of IL-6 have been found in the induced sputum of
patients with COPD, particularly during exacerbation. Park et al. found increased IL-6 levels
in the Bronchioalveolar lavage fluid of patients with non-specific interstitial
pneumonia/fibrosis and in some patients with interstitial pneumonia. (3) Dowlati et al. have
reported increased levels of IL-6 in the serum and BAL fluid of patients with lung cancer.
(4) A recent study by Bhowmik et al. found increased IL-6 and IL-8 levels in the sputum of
COPD patients with frequent exacerbations. (5) Also, at another study Exhaled interleukin-6
and leukotriene B4 levels may be useful noninvasive markers of airway inflammation in
cigarette smokers. (6) These studies and our novel method after clinical trials may open the
field for future therapies for covid-19 and post covid-19 lung fibrosis by inhaler transport
medicines as a new challenge for overcome sequels of this pandemic. And this suggested new
procedure for measurement of exhaled il-6 take us to study which is IL-6 is risky is IL-6
produced from airway or endocrine IL-6 or immune IL-6 From previous studies we need a
procedure acceptable to patients and easy, noninvasive, sensitive he study involved 20
healthy controls and 20 patients with moderate to severe covid-19 according to cdc
classifaction and 20 patients post covid-19 with lung fibrosis to estimate the measurment of
interleukin-6 at exhaled condensate, this clinical randomized control study consists of 3
arms for 6 month ( all participants above 18 years non prgnant humans )
