What side effects are associated with this type of intervention?

Common treatments for pulmonary fibrosis, such as nintedanib and pirfenidone, are associated with several side effects. Nintedanib can cause gastrointestinal issues like diarrhea, nausea, and vomiting, as well as liver enzyme elevations. Pirfenidone may lead to gastrointestinal discomfort, skin rash, and photosensitivity. Both drugs can also cause fatigue and loss of appetite. These side effects highlight the need for careful monitoring and management during treatment.

What prior FDA approvals exist?

The FDA has approved two primary drugs for the treatment of idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. Pirfenidone is an anti-fibrotic agent that helps reduce lung fibrosis and inflammation, while nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis. Both drugs have been shown to slow disease progression in IPF patients. These treatments share similarities with the potential anti-fibrotic and anti-inflammatory properties being studied in the trial for VL-P22 and VL-PX10.

What other types of research exist?

Promising alternatives for pulmonary fibrosis treatment include: <ol> <li>Nintedanib: Shown to slow disease progression in various fibrotic lung diseases, including IPF and RA-ILD.</li> <li></li> </ol> Pirfenidone: Demonstrated to slow lung function decline and reduce mortality in IPF patients. 3. Tacrolimus: Combined with methylprednisolone, it has shown improved survival in AE-IPF patients. 4. Hemoperfusion with polymyxin-B immobilized fiber: Improved oxygenation and survival rates in AE-IPF patients. 5. Pamrevlumab: An anti-connective tissue growth factor therapy showing promise in clinical trials for IPF.

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Stem Cell Therapy

EV-Pure™ + WJ-Pure™ for Pulmonary Fibrosis

Q: What is the mechanism of action of this treatment?

The most common treatments for Pulmonary Fibrosis, such as nintedanib and pirfenidone, work primarily through antifibrotic mechanisms. Nintedanib is a tyrosine kinase inhibitor that blocks multiple pathways involved in fibrosis, thereby slowing disease progression. Pirfenidone has both antifibrotic and anti-inflammatory properties, reducing fibroblast proliferation and collagen synthesis. These mechanisms are crucial for Pulmonary Fibrosis patients as they help to slow the decline in lung function and reduce the frequency of acute exacerbations. Emerging treatments like phosphodiesterase inhibitors and pentraxin 2 also show promise by targeting inflammation and fibrosis, potentially offering additional therapeutic options.

Phase 2

Waitlist Available

Research Sponsored by Vitti Labs, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to perform a 6-minute walk test

Adequate hepatic function as evidenced by ALT and AST < 2X ULN and bilirubin < 1.5X ULN for the reference lab

Must not have

Severe asthma on chronic therapy with biologics or steroids

Clinically relevant heart condition such as uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Summary

This trial tests a combination of two substances, VL-P22 and VL-PX10, given to Covid-19 patients with lung fibrosis. These patients have lung damage and severe breathing issues. The treatment aims to repair lung tissue and improve breathing by reducing lung scarring.

Who is the study for?

This trial is for adults aged 25-90 with a history of COVID-19 and confirmed pulmonary fibrosis. They must have good kidney, liver, and blood cell function, not be currently infected with COVID-19, able to walk for six minutes unaided, and if of childbearing age, agree to use birth control. Excluded are those with severe heart conditions or other serious illnesses that could affect safety or compliance.

What is being tested?

The study tests the effectiveness of VL-PX10 combined with VL-P22 against lung damage from COVID-19 compared to a placebo group. Both groups receive standard care as well. The goal is to see if these treatments can improve breathing issues and exercise tolerance in patients who've developed pulmonary fibrosis after recovering from COVID-19.

What are the potential side effects?

While specific side effects aren't listed here, clinical trials like this one typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to more serious ones related to organ functions which will be closely watched given the participants' existing lung condition.

Eligibility Criteria

Inclusion Criteria

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

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I can walk for 6 minutes without assistance.

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My liver tests are within normal limits.

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I had COVID-19 and now have been diagnosed with Pulmonary Fibrosis.

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I am between 25 and 90 years old.

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My kidney function is within the normal range.

Exclusion Criteria

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

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I have severe asthma and am on long-term biologic or steroid treatment.

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I do not have a serious heart condition that is not under control.

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I currently have cancer or had cancer that is not in remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.

To evaluate the efficacy of VL-PX10 and VL-P22 administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo.

Secondary study objectives

Change in Pulse Oximetry During the 6MWT

Incidence of Re-Hospitalization

Quality of Life assessment as collected using the SF-36

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental/treatment armExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 8Eligibility 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 Pulmonary Fibrosis, such as nintedanib and pirfenidone, work primarily through antifibrotic mechanisms. Nintedanib is a tyrosine kinase inhibitor that blocks multiple pathways involved in fibrosis, thereby slowing disease progression. Pirfenidone has both antifibrotic and anti-inflammatory properties, reducing fibroblast proliferation and collagen synthesis. These mechanisms are crucial for Pulmonary Fibrosis patients as they help to slow the decline in lung function and reduce the frequency of acute exacerbations. Emerging treatments like phosphodiesterase inhibitors and pentraxin 2 also show promise by targeting inflammation and fibrosis, potentially offering additional therapeutic options.