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

Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387239
• Other study ID #: EW-02
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Vitti Labs, LLC
• Contact: Mukesh Kumar
• Phone: 2407504893
• Email: mkumar[@]fdamap.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Fibrosis
• Pulmonary Fibrosis
• Respiratory Tract Infections

Intervention

Drug:
• VL-PX10 and VL-P22 plus standard care
The treatment consists of administration of VL-P22 and VL-PX10 plus standard care
• Placebo
Saline plus standard care

Locations

Country	Name	City	State
United States	Kit Bartalos	Liberty	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Vitti Labs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Pulse Oximetry During the 6MWT	Oxygen saturation (pulse oximetry) during the 6-minute walk test (6MWT)	3 months
Secondary	Incidence of Re-Hospitalization	Incidence of hospitalization after initial discharge and initiating treatment	3 months
Secondary	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