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

NCT05157204 | Unknown

• 1 other identifier: saudia arabia
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 )

Conditions

Inflammatory Response; Immunological Abnormality; COVID-19

Outcome Measures

Primary Outcomes (1)

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

  6 month

Study Arms (3)

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

measurment of interleukin-6 at exhaled condensate PROCEDURE

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

20 healthy controls adult non pregnant humans f; adult 20 patients with moderate to severe covid-19; adult 20 patients with moderate to severe postcovid-19

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• healthy subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Amr Ahmed

CONTACT

+966597310032; drmedahmed@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Saudia Arabia , Riyadh . public health , First health cluster

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 14, 2021
• Study Start: January 26, 2022
• Primary Completion: April 26, 2022
• Study Completion: June 1, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL