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Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After COVID- 2019 .

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06043882
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Ain Shams University

Study Description
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Brief Summary:

The goal of this observational study is to learn about sarcoidosis development after COVID-19 infection.

The main question it aims to answer is:

  • prevalence of Sarcoidosis among patients previously infected with COVID-19.

Participants will:

  • provide previous positive RT-PCR for COVID-19
  • Have computed tomography of the Chest with suggestive findings of sarcoidosis
  • Have bronchoscopic guided biopsies and pathological analysis to detect number of patients with sarcoidosis.

Condition or disease Intervention/treatment
Sarcoidosis COVID-19 Procedure: flexible bronchoscopy

Detailed Description:

This prospective cross sectional study was performed on a total of 55 patients with mediastinal and /or hilar lymphadenopathy with or without lung infiltrates referred to Bronchoscopy unit , Chest department, Ain-Shams University hospital for biopsy taking and diagnosis.

All patients were subjected to the following : history taking , clinical examination , radiological assessment by computed tomography (CT )chest , fiberoptic bronchoscopy where biopsies were taken either by conventional-Trans-bronchial needle aspiration (c-TBNA) , endo-bronchial ultrasound (EBUS-TBNA) or direct forceps biopsies and sent for histopathological examination and if the patient had past history of COVID-19 infection with previous positive reverse transcriptase- polymerase chain reaction assay (RT-PCR).

Study Design
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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After Corona Virus Disease of 2019 Infection.
Actual Study Start Date : November 1, 2022
Actual Primary Completion Date : April 30, 2023
Actual Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
the relation between COVID-19 infection and the development of sarcoidosis .
All patients were subjected to the following : history taking , clinical examination , radiological assessment by CT chest , fiberoptic bronchoscopy where biopsies were taken either by conventional TBNA (c-TBNA) , EBUS-TBNA or direct forceps biopsies and sent for histopathological examination and if the patient had past history of COVID-19 infection with previous positive RT-PCR.
 Procedure: flexible bronchoscopy
fiberoptic bronchoscopy was done where biopsies were taken either by conventional TBNA (c-TBNA) , EBUS-TBNA or direct forceps biopsies and sent for histopathological examination


Outcome Measures
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Primary Outcome Measures :
  1. Number and risk factors of sarcoidosis development after COVID -19 infection as diagnosed by TBNA guided tissue biopsies in bronchoscopy unit, chest department, Ain Shams university. [ Time Frame: 6 months ]
    Number of COVID-19 patients diagnosed by TBNA guided biopsies as having granulomatous tissue suggesting sarcoidosis development, and risk factors that associate its development.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously diagnosed as COVID -19 by RT-PCR ,with mediastinal or hilar lymphadenopathy with or without lung infiltrates referred to bronchoscopy unit ,Chest Department, Ain-Shams University Hospital for diagnosis.
Criteria

Inclusion Criteria:

  • All adult patients with previous positive RT-PCR for COVID -19 and CT chest findings of mediastinal and or hilar lymphadenopathy with or without lung infiltrate will be included. .

Exclusion Criteria:

  • Patients younger than 18 years old Patients
  • Patients refuse to participate in the study
  • Patients previously diagnosed as sarcoidosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043882


Locations
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Egypt
Hoda atiatullah
Cairo, Egypt, 02
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Hoda A Mohamed, MD faculty of medicine, Ain Shams university
More Information
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Responsible Party: Ain Shams University
ClinicalTrials.gov Identifier: NCT06043882    
Other Study ID Numbers: FMASU-R 151/2022
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ain Shams University:
Sarcoidosis
COVID-19
SARS-CoV-2
Granulomatous disease
Additional relevant MeSH terms:
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COVID-19
Sarcoidosis
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases