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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• Sarcoidosis

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