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Macrophage Regulation of Ozone-Induced Lung Inflammation
ClinicalTrials.gov; 03/03/2023; TrialID: NCT05773001
Clinical Trial Register | ICTRP | ID: ictrp-NCT05773001
ABSTRACT

Condition

SARS-CoV-2 Pneumonia

Intervention

Drug Ozone

Primary 

outcome:

Change in the abundance of monocyte-derived alveolar macrophages

Criteria


Inclusion Criteria

- Individuals between 18-55 yrs. of age (No subject will be excluded from the study on
the basis of gender or ethnicity)

- Individuals with knowledge of prior SARS-CoV-2 infection history allowing them to be
segregated into one of three cohorts

- Cohort 1 - No history of SARS-CoV-2 infection (defined as no symptoms consisted
with SARS-CoV-2 nor history of a positive SARS-CoV-2 test)

- Cohort 2 - Documented mild SARS-CoV-2 infection (a positive test, either PCR- or
antigen-based) but with mild to no symptoms and no evidence of a lower
respiratory tract infection (including no hospitalization, and no oxygen use)

- Cohort 3 - History of SARS-CoV-2 infection and symptoms/imaging consistent with a
lower respiratory tract infection who have recovered, are >6 months out from
their infection, and have normal lung function (spirometry with FVC, FEV1 and
FEV1/FVC)

- There will be no maximal period from SARS-CoV-2 infection for inclusion in
the study, the minimal period will be >6 months out from infection

Exclusion Criteria

- Individuals with prior SARS-CoV-2 pneumonia who have ongoing respiratory symptoms, are
still using supplemental oxygen, or have abnormal lung function

- Individuals with prior SARS-CoV-2 infection that cannot provide documentation of a
positive test

- Current smokers of tobacco products including e-cigarettes or those with previous
smoking history within the prior 5 years

- Pregnant women and women who are presently lactating.

- Subjects that have received antibiotic administration or an upper respiratory
infection within the previous 4 weeks

- College and graduate students or employees who are under direct supervision by any of
the investigators in this protocol

- Alcohol or illicit substance abuse

- Chronic cardio/pulmonary respiratory disorders or other medical conditions as
determined by the investigator

- Increased airway hyperresponsiveness at baseline as measured by a positive
methacholine challenge response (methacholine PC20 FEV1 < 4 mg/ml)

- Subjects will be requested to refrain from antihistamines, nonsteroidal
anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and
supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.


Collection: Clinical trial registers Database: ICTRP Year: 2023 Document Type: Clinical Trial Register

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Collection: Clinical trial registers Database: ICTRP Year: 2023 Document Type: Clinical Trial Register