Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

NCT06135597 | Unknown

• 1 other identifier: 2023-01-002BC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The study will observed for at least one year for overall survival

  6 months intervel

Secondary Outcomes (1)

• Oppertunistic infection

  yearly

Study Arms (3)

Aspergillosis

Patients with aspergillosis

Other: 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

Control

Patients without history of COVID infection and without aspergillosis

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

Interventions

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

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

Aspergillosis; COVID; Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Shiang Fen Huang

Taipei, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood test will be obtained within first 3 months, 3-6 months, and 12 months after anticipates agree to enrolled into the study.

MeSH Terms

Conditions

Aspergillosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• SF Huang

  Taipei Veterans General Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SF Huang

CONTACT

+886-28712121; sfhuang.dr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: March 23, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)