Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

Aspergillosis Clinical Trial

Official title:

Role of Cellular Immune Regulation in Acute Exacerbation and Chronic Aspergillus Infection After COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135597
• Other study ID #: 2023-01-002BC
• Status: Recruiting
• Start date: March 23, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: SF Huang
• Phone: +886-28712121
• Email: sfhuang.dr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Infections

Intervention

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

Locations

Country	Name	City	State
Taiwan	Shiang Fen Huang	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The study will observed for at least one year for overall survival	6 months intervel
Secondary	Oppertunistic infection	Infection not by aspergillus or COVID	yearly