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Inflammatory ResponseNCT05157204

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 of Inflammatory Response and Immunological Abnormality, run by Ministry of Health, Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
measurment of interleukin-6 at exhaled condensate
Type of treatment
Surgery or procedure
How many people
60 participants
Where
No sites listed yet
Study dates
26 Jan 2022to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

About this study

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

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 )

Being tested
measurment of interleukin-6 at exhaled condensate
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measurment of interleukin-6 at exhaled condensateProcedure or surgery

    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

Study groups in NCT05157204
Study groupRoleWhat they receive
adult 20 patients with moderate to severe covid-19adult 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
Receives: Procedure: measurment of interleukin-6 at exhaled condensate
20 healthy controls adult non pregnant humans f20 healthy adults above 18 years non pregnant for measurment of interleukin-6 from exhaled condensate
Receives: Procedure: measurment of interleukin-6 at exhaled condensate
adult 20 patients with moderate to severe postcovid-19adult 20 post covid-19 patients with moderate to severe covid-19 for measurment of interleukin-6 from exhaled condensate
Receives: Procedure: measurment of interleukin-6 at exhaled condensate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start26 Jan 2022 (estimated)
  3. Primary completion26 Apr 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157204
Sponsor's protocol ID
saudia arabia
Status last verified
Dec 2021
First submitted
11 Dec 2021
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Response and Immunological Abnormality, run by Ministry of Health, Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amr Ahmed (+966597310032, drmedahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measurement of interleukin-6 at exhaled condensate in covid-19, postcovid-19 ,healthy subjects (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

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