SARS-CoV-2 Pneumonia Clinical Trial
— MOLIOfficial title:
Macrophage Regulation of Ozone-Induced Lung Inflammation
The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2028 |
Est. primary completion date | May 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Robert Tighe, MD | National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in composition of BAL immune cells following O3 exposure | Change in composition of BAL immune cells following O3 exposure will identify unique immune cells driving inflammation and physiologic responses | Baseline, Day 18-20 | |
Other | Comparison between BAL immune cells and immune cells obtained from bronchial brushings | Comparison between BAL immune cells and immune cells obtained from bronchial brushings and the relationship to O3 induced inflammation and physiologic responses | Baseline, Day 18-20 | |
Other | Interactions between airway epithelial cells and immune cells | o Interactions between airway epithelial cells and immune cells by RNA-sequencing to define an "interactome" | Baseline, Day 18-20 | |
Primary | Change in the abundance of monocyte-derived alveolar macrophages | - Change in the abundance of monocyte-derived alveolar macrophages and association to measures of O3-induced inflammation (BAL cell neutrophils, albumin and cytokine production) | Baseline, Day 18-20 | |
Secondary | Change in the abundance of autonomous CSF-1 expression in alveolar macrophages | - Change in the abundance of autonomous CSF-1 expression in alveolar macrophages and association to measures of O3-induced inflammation | Baseline, Day 18-20 | |
Secondary | Association between prior evidence of COVID pneumonia | Association between prior evidence of COVID pneumonia, when compared to non-COVID infected individuals, and O3-induced inflammation | Baseline, Day 18-20 | |
Secondary | Association between prior evidence of COVID infection without pneumonia | Association between prior evidence of COVID infection without pneumonia, when compared to non-COVID infected individuals and O3-induced inflammation | Baseline, Day 18-20 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04382625 -
Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial
|
Phase 4 | |
Enrolling by invitation |
NCT04602442 -
Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia
|
Phase 2 | |
Recruiting |
NCT04316949 -
Predictors of Respiratory Failure in SARS-Cov-2 Infection
|
||
Recruiting |
NCT04605757 -
Long-term Evolution of Pulmonary Involvement of Novel SARS-COV-2 Infection (COVID-19): Follow the Covid Study
|
||
Not yet recruiting |
NCT04405921 -
Hydroxychloroquine, Azithromycin in the Treatment of Covid-19
|
Phase 3 | |
Completed |
NCT05465785 -
A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell)
|
N/A | |
Completed |
NCT04491240 -
Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia.
|
Phase 1/Phase 2 |