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Ozone Exposure for Lung Inflammation (MOLI Trial)
Phase 1
Recruiting
Research Sponsored by Robert Tighe, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 18-20
Awards & highlights
MOLI Trial Summary
This trial studies how past respiratory infections affect how easily a person gets lung inflammation from environmental triggers.
Who is the study for?
This trial is for adults aged 18-55 with or without a history of mild to moderate COVID-19, who have recovered and are over 6 months post-infection with normal lung function. Excluded are those with substance abuse issues, pregnant or lactating women, individuals under the investigators' supervision, recent antibiotic use or respiratory infection, chronic cardio/pulmonary conditions, ongoing COVID-19 symptoms or abnormal lungs.Check my eligibility
What is being tested?
The study aims to understand how previous respiratory infections like COVID-19 influence lung inflammation after being exposed to environmental factors like ozone. Participants will be divided into cohorts based on their SARS-CoV-2 infection history and assessed for lung inflammation response.See study design
What are the potential side effects?
While specific side effects aren't listed for exposure to ozone in this context, generally it can cause coughing, throat irritation, chest pain and shortness of breath especially in people sensitive to pollutants.
MOLI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had COVID-19, recovered over 6 months ago, and my lung function tests are normal.
Select...
I have never had COVID-19 or tested positive for it.
MOLI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 18-20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 18-20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the abundance of monocyte-derived alveolar macrophages
Secondary outcome measures
Association between prior evidence of COVID infection without pneumonia
Association between prior evidence of COVID pneumonia
Change in the abundance of autonomous CSF-1 expression in alveolar macrophages
Other outcome measures
Change in composition of BAL immune cells following O3 exposure
Comparison between BAL immune cells and immune cells obtained from bronchial brushings
Interactions between airway epithelial cells and immune cells
MOLI Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
SARS-CoV-2 pneumonia
Group II: Cohort 2Experimental Treatment1 Intervention
Documented mild SARS-CoV-2 infection
Group III: Cohort 1Experimental Treatment1 Intervention
No history of SARS-CoV-2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozone
2019
Completed Phase 2
~810
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Robert Tighe, MDLead Sponsor
2 Previous Clinical Trials
36 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,750 Total Patients Enrolled
National Institute of Environmental Health Sciences (NIEHS)NIH
284 Previous Clinical Trials
1,232,637 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had COVID-19, recovered over 6 months ago, and my lung function tests are normal.I had COVID-19 more than 6 months ago.I had COVID-19 pneumonia, still have breathing issues, use oxygen, or my lung function isn't normal.You had COVID-19 before, but you can't show a positive test result.I have never had COVID-19 or tested positive for it.I had a mild or asymptomatic COVID-19 infection without needing hospitalization or oxygen.People who have had a previous SARS-CoV-2 infection and are separated into different groups based on their history.I can avoid taking antihistamines, NSAIDs, certain antioxidants, and vitamins for a week before and during the test.You have a history of drinking too much alcohol or using illegal drugs.I have not taken antibiotics or had a respiratory infection in the last 4 weeks.You have long-term heart, lung, or other health problems as decided by the doctor.I am between 18 and 55 years old.I am currently smoking or have smoked within the last 5 years.Your airways are extra sensitive, as shown by a positive test when breathing in methacholine.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 2
- Group 3: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this treatment modality associated with any adverse effects?
"The safety of this therapy is assessed as a 1, due to the fact that it's currently undergoing Phase 1 clinical trials. This means there is only preliminary evidence supporting both its effectiveness and security."
Answered by AI
To whom is participation in this clinical experiment open?
"To be eligible for participation, individuals must have contracted COVID-19 pneumonia and their age range must fall between 18 to 55 years old. The trial is seeking a total of 100 participants."
Answered by AI
Is participation in this trial open to those aged 40 and above?
"The age range accepted for this trial is between 18 and 55. Separately, there are 61 studies available to minors and 440 trials targeting patients over the age of 65."
Answered by AI
Does this clinical research still have open enrollment?
"The information available on clinicaltrials.gov signifies that this trial is no longer accepting participants, as it was first posted in May 1st 2023 and last modified three months ago. Nevertheless, there are presently 550 other trials recruiting patients throughout the world."
Answered by AI
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