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Status unknownNCT05157204Updated Dec 14, 2021

Measurment of Interleuukin-6 at Exhaled Breath Condensate of Covid-19 Patients and Post Covid-19 Patients With Lung Fibrosis Randomized Controlled Study

An observational study in Inflammatory Response, Immunological Abnormality and COVID-19, sponsored by Ministry of Health, Saudi Arabia. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by Ministry of Health, Saudi Arabia · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
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Study 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 )

Read the detailed 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 )

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Conditions studied

  • Inflammatory Response
  • Immunological Abnormality
  • COVID-19
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 60 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ministry of Health, Saudi Arabia is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

the partcipants are 60 human subjects divided to 3 arms 20 healthy subjects 20 covid-19 patients with new real time PCR positive and during first 10 days of result 20 postcovid-19 patients with lung fibrosis and also current real time PCR positive all subjects have informed consent

Inclusion criteria

  • age above 18 years
  • covid-19 patients (20) with real time PCR positive test moderate to severe according to CDC classification
  • smokers are included
  • post-covid 19 patients with real-time pcr positive test
  • 20 healthy subjects

Exclusion criteria

Exclusion Criteria:

  • below 18 years and above 80 years pregnant womens any medications as anti-il-6 unstable cases history of copd cases or lung disease or lung cancer
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • adult 20 patients with moderate to severe covid-19

    adult 20 covid-19 patients with moderate to severe covid-19. for measurment of interleukin-6 from exhaled condensate during first 10 days of postive PCR

    Procedure: measurment of interleukin-6 at exhaled condensate

  • 20 healthy controls adult non pregnant humans f

    20 healthy adults above 18 years non pregnant for measurment of interleukin-6 from exhaled condensate

    Procedure: measurment of interleukin-6 at exhaled condensate

  • adult 20 patients with moderate to severe postcovid-19

    adult 20 post covid-19 patients with moderate to severe covid-19 for measurment of interleukin-6 from exhaled condensate

    Procedure: measurment of interleukin-6 at exhaled condensate

Interventions

  • Proceduremeasurment of interleukin-6 at exhaled condensate

    the breath condensate samples were collected using a specially designed condensing chamber ( Ecoscreen; Jaeger, Hoechberg, Germany) to measure the interleukin-6 at exhaled condensate of 60 participants

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What researchers measure

Primary outcomes

  1. measurement of interleukin-6 at exhaled condensate in covid-19, postcovid-19 ,healthy subjects

    Time frame: 6 month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05157204
Lead sponsor
Ministry of Health, Saudi Arabia
Responsible party
Amr kamel khalil Ahmed (Saudia Arabia , Riyadh . public health , First health cluster, Ministry of Health, Saudi Arabia) — Principal investigator
First posted
Dec 14, 2021
Start date
Jan 26, 2022 (estimated)
Primary completion
Apr 26, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Dec 14, 2021

Study contacts

Amr Ahmed
Contact
drmedahmed@gmail.com
+966597310032

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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