Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aspergillosis
• Intervention / Treatment: Other: This is a blood test without regarding to intervention nor diagnostic tests

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: SF Huang; Phone Number: 7494 +886-28712121; Email: sfhuang.dr@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Shiang Fen Huang
    • Contact: Shiang-Fen Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study enrolled patients with and without COVID infection, and with aspergillus coinfection.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aspergillosis; Patients with aspergillosis	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
COVID; Patients with history of COVID infection and without aspergillosis	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
Control; Patients without history of COVID infection and without aspergillosis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The study will observed for at least one year for overall survival	6 months intervel

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oppertunistic infection	Infection not by aspergillus or COVID	yearly

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Science and Technology Council
• Investigators: Principal Investigator: SF Huang, Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Mycoses; Infections; Aspergillosis
• Other Study ID Numbers: 2023-01-002BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No