Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

NCT ID: NCT06135597

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-23

Study Completion Date

2025-12-31

Brief Summary

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This study aims to collect clinical cases and follow-up data from patients with chronic pulmonary aspergillosis, post-COVID-19 aspergillosis, and post-COVID-19 patients without aspergillosis. Using in vitro assays, we will measure the phagocytic function of neutrophils when stimulated by fungal hyphae, their ability to produce neutrophil extracellular traps (NETs), the expression of cell surface molecules at the time of enrollment, changes in cell surface molecule expression after stimulation with fungal hyphae, and the quantification of autoantibodies in the blood. This research will focus on the short-term (within 3 months), medium-term (6-12 months), and long-term (more than 12 months) changes in cell surface molecules and functions following infection.

Detailed Description

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Conditions

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Aspergillosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aspergillosis

Patients with aspergillosis

This is a blood test without regarding to intervention nor diagnostic tests

Intervention Type OTHER

This is a blood test without regarding to intervention nor diagnostic tests

COVID

Patients with history of COVID infection and without aspergillosis

This is a blood test without regarding to intervention nor diagnostic tests

Intervention Type OTHER

This is a blood test without regarding to intervention nor diagnostic tests

Control

Patients without history of COVID infection and without aspergillosis

This is a blood test without regarding to intervention nor diagnostic tests

Intervention Type OTHER

This is a blood test without regarding to intervention nor diagnostic tests

Interventions

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This is a blood test without regarding to intervention nor diagnostic tests

This is a blood test without regarding to intervention nor diagnostic tests

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed cases include patients diagnosed with pulmonary aspergillosis, acute or subacute Aspergillus infections, and aspergillosis in other anatomical sites (such as sinuses, middle ear, liver). Additionally, this study will enroll patients with chronic obstructive pulmonary disease (COPD), asthma, or those undergoing treatment for pulmonary tuberculosis who continue to exhibit worsening pulmonary radiological findings without a clear etiology, necessitating hospitalization or outpatient care for unexplained community-acquired pneumonia. Patients with bronchiectasis, emphysema, pulmonary fibrosis, or other chronic pulmonary conditions who are under continuous follow-up and treatment at our institution will also be included if clinically diagnosed with aspergillosis.

The control group will consist of patients who, based on clinical evidence, have no history of prior exposure to Aspergillus or aspergillosis infection after contracting COVID-19.

Exclusion Criteria

* Individuals aged below 20, pregnant women, patients with advanced-stage (stage II and above) lung cancer, individuals diagnosed with malignancies, patients with mental health disorders requiring consent from a legal guardian for participation, and those in critical end-stage conditions.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council

FED

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SF Huang

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taipei, Taiwan

Locations

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Shiang Fen Huang

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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SF Huang

Role: CONTACT

+886-28712121 ext. 7494

Facility Contacts

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Shiang-Fen Huang

Role: primary

Other Identifiers

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2023-01-002BC

Identifier Type: -

Identifier Source: org_study_id

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