Clinical trial NCT06135597: Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection
Official title: Role of Cellular Immune Regulation in Acute Exacerbation and Chronic Aspergillus Infection After COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aspergillosis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Science and Technology Council
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study enrolled patients with and without COVID infection, and with aspergillus coinfection.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 6 months intervel
Secondary outcomes:
measure: Oppertunistic infection
timeFrame: yearly
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shiang Fen Huang
Study officials:
affiliation: Taipei Veterans General Hospital, Taipei, Taiwan
name: SF Huang
role: PRINCIPAL_INVESTIGATOR
References: