NCT06043882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 22, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

August 31, 2023

Last Update Submit

September 21, 2023

Conditions

Keywords

SarcoidosisCOVID-19SARS-CoV-2Granulomatous disease

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (1)

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

Interventions

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

the relation between COVID-19 infection and the development of sarcoidosis .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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. .

You may not qualify if:

  • Patients younger than 18 years old Patients
  • Patients refuse to participate in the study
  • Patients previously diagnosed as sarcoidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoda atiatullah

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

SarcoidosisCOVID-19

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hoda A Mohamed, MD

    faculty of medicine, Ain Shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 21, 2023

Study Start

November 1, 2022

Primary Completion

April 30, 2023

Study Completion

May 30, 2023

Last Updated

September 22, 2023

Record last verified: 2023-07

Locations