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NCT06043882 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After Corona Virus Disease of 2019 Infection.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06043882
Other study ID # FMASU-R 151/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date May 30, 2023

Study information
Verified date July 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date May 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Hoda atiatullah Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Number of COVID-19 patients diagnosed by TBNA guided biopsies as having granulomatous tissue suggesting sarcoidosis development, and risk factors that associate its development. 6 months
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