Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT06135597
Collaborator
National Science and Technology Council (U.S. Fed)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: This is a blood test without regarding to intervention nor diagnostic tests

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Cellular Immune Regulation in Acute Exacerbation and Chronic Aspergillus Infection After COVID-19 Infection
Actual Study Start Date :
Mar 23, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [6 months intervel]

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

Secondary Outcome Measures

  1. Oppertunistic infection [yearly]

    Infection not by aspergillus or COVID

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shiang Fen Huang Taipei Taiwan 112

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: SF Huang, Taipei Veterans General Hospital, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT06135597
Other Study ID Numbers:
  • 2023-01-002BC
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023