What side effects are associated with this type of intervention?

Common treatments for Coronavirus Pneumonia include azithromycin, which may cause gastrointestinal symptoms such as nausea and diarrhea; ivermectin, which has been associated with neurologic adverse effects and toxicity, especially when obtained without prescription; and fluvoxamine, which can cause side effects like nausea, dizziness, and sleep disturbances. Chinese herbal medicines have shown some promise but require more rigorous studies to confirm their efficacy and safety. General symptomatic treatments like acetaminophen and NSAIDs are generally well-tolerated but can cause liver damage and gastrointestinal issues, respectively, if used excessively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Coronavirus Pneumonia. Treatments have focused on supportive care, including the use of antipyretics and analgesics for symptom management. Investigational drugs such as hydroxychloroquine, ivermectin, and fluvoxamine have been studied, but none have proven effective or received FDA approval for this indication. The management of COVID-19 primarily involves supportive care and, in severe cases, hospitalization and advanced respiratory support.

What other types of research exist?

Promising novel alternatives for assessing respiratory health in coronavirus pneumonia patients include the use of lung ultrasound for evaluating lung inflammation and damage, as well as digital and telerehabilitation programs to monitor and improve lung function. Additionally, outpatient pulmonary rehabilitation programs have shown improvements in exercise capacity, functional status, dyspnea, fatigue, and quality of life for patients with long COVID.

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Other

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)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 18-20

Awards & highlights

No Placebo-Only Group

Summary

This trial involves participants breathing in clean air or ozone to see how their lungs react. It focuses on people who have had past respiratory infections to understand if these infections make their lungs more sensitive to pollution.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently smoking or have smoked within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 18-20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 18-20

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 18-20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the abundance of monocyte-derived alveolar macrophages

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~870

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Coronavirus Pneumonia include systemic glucocorticoids, antibiotics, and supportive therapies. Systemic glucocorticoids, such as dexamethasone, reduce inflammation by suppressing the immune response, which can help decrease lung inflammation and improve oxygenation in severe cases. Antibiotics are used to treat or prevent secondary bacterial infections that can complicate viral pneumonia. Supportive therapies, including antipyretics and analgesics, help manage symptoms like fever and pain. These treatments are crucial for managing lung inflammation and preventing complications, thereby improving outcomes for patients with Coronavirus Pneumonia.

Registered clinical trials investigating treatment of long COVID: a scoping review and recommendations for research.