Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

Recruiting

• Conditions: Aspergillosis
• Interventions: Other: This is a blood test without regarding to intervention nor diagnostic tests

• Registration Number: NCT06135597
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-03-23
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-12
• Last Update Submitted: 2023-11-12
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	This is a blood test without regarding to intervention nor diagnostic tests	Patients without history of COVID infection and without aspergillosis
COVID	This is a blood test without regarding to intervention nor diagnostic tests	Patients with history of COVID infection and without aspergillosis
Aspergillosis	This is a blood test without regarding to intervention nor diagnostic tests	Patients with aspergillosis

Primary Outcome Measures

Name	Time	Method
Overall survival	6 months intervel	The study will observed for at least one year for overall survival

Secondary Outcome Measures

Name	Time	Method
Oppertunistic infection	yearly	Infection not by aspergillus or COVID

Trial Locations

Locations (1)

Shiang Fen Huang; 🇨🇳 Taipei, Taiwan