Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19

The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration, reduction of exercise tolerance, and concomitant development of persistent fibrotic lung damage. This study intends to evaluate benefits of a combination of VL-P22 and VL-PX10 in Covid-19 patients exhibiting pulmonary fibrosis.

Study Overview

• Status: Suspended
• Conditions: Pulmonary Fibrosis; COVID-19 Respiratory Infection
• Intervention / Treatment: Drug: Placebo; Drug: VL-PX10 and VL-P22 plus standard care

Detailed Description

Multiple clinical trials are underway to explore options for treatment of pulmonary fibrosis in patients with history of COVID. Mesenchymal stem cell (MSC)-based therapies have been used worldwide for various pulmonary diseases. A recent review of over 110 reports of clinical trials worldwide with MSC-based therapies in pulmonary diseases found that these therapies have been reported to be safe and effective in the treatment of acute/viral pulmonary disease, community-acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia (BPD), interstitial lung diseases (ILD), chronic pulmonary fibrosis, bronchiolitis obliterans syndrome (BOS) and lung cancer. A phase 2 clinical trial in 101 severe Covid-19 patients with lung damage using human umbilical cord derived MSCs found that the treatment exerted numerical improvement in whole lung lesion volume and the 6-minute walk test from baseline to day 28 compared with the placebo.

This proof of concept, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous infusion of VL-PX10 and VL-P22, versus placebo, for use in the treatment of Covid induced Pulmonary Fibrosis. This is an add-on treatment study; subjects will be allowed to take standard of care treatments available.

The study will have two arms (n=10 each):

1. Experimental/treatment arm: VL-PX10 and VL-P22 plus standard care
2. Placebo: Saline plus standard care

The study duration would be 5 days of treatment plus 12 weeks follow up.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Liberty, Missouri, United States, 64068
      • Kit Bartalos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects will be eligible for enrollment in the study only if they meet the following criteria:

  1. Male or female, aged between 25 years (including) to 90 years old
  2. Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis
  3. Negative to current Covid-19 infection as tested by RT-PCR/rapid antigen tests
  4. Able to perform a 6-minute walk test

  5. Blood routine, liver and kidney functions test values are within controllable range

     1. Adequate hepatic function as evidenced by ALT and AST < 2X ULN and bilirubin < 1.5X ULN for the reference lab
     2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
     3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L
  6. If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.

Exclusion Criteria:

• Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:

  1. Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease
  2. Severe asthma on chronic therapy with biologics or steroids
  3. Active smokers as defined as individuals who currently smokes at least one cigarette or equivalent product a day. (Ex-smokers who had regularly smoked but who had not smoked the previous month are eligible)
  4. Evidence of active malignancy, or prior history of active malignancy not in remission.
  5. Life expectancy of < 6 months
  6. Patient included in another ongoing interventional therapeutic trial.
  7. Pregnant or Lactating.
  8. Serious or life-threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Saline plus standard care
Experimental: Experimental/treatment arm	Drug: VL-PX10 and VL-P22 plus standard care; The treatment consists of administration of VL-P22 and VL-PX10 plus standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.	Presence of adverse events in less than 10% of the study population, as a measure of safety	3 months
To evaluate the efficacy of VL-PX10 and VL-P22 administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo.	Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Re-Hospitalization	Incidence of hospitalization after initial discharge and initiating treatment	3 months
Quality of Life assessment as collected using the SF-36	The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being, and overall evaluation of health in 8 domains.	3 months
Change in Pulse Oximetry During the 6MWT	Oxygen saturation (pulse oximetry) during the 6-minute walk test (6MWT)	3 months

Collaborators and Investigators

• Sponsor: Vitti Labs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; COVID-19; Pulmonary Fibrosis; Respiratory Tract Infections
• Other Study ID Numbers: EW-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No