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

NCT05387239 | Suspended Phase 2 FDA Drug

• 1 other identifier: EW-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Fibrosis; COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Pulse Oximetry During the 6MWT

  3 months

• Incidence of Re-Hospitalization

  3 months

• Quality of Life assessment as collected using the SF-36

  3 months

Study Arms (2)

Experimental/treatment arm

EXPERIMENTAL

Drug: VL-PX10 and VL-P22 plus standard care

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VL-PX10 and VL-P22 plus standard care DRUG

The treatment consists of administration of VL-P22 and VL-PX10 plus standard care

Experimental/treatment arm

Placebo DRUG

Saline plus standard care

Placebo

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet the following criteria:
• Male or female, aged between 25 years (including) to 90 years old
• Confirmed and documented COVID-19 infection history with confirmed diagnosis of Pulmonary Fibrosis
• Negative to current Covid-19 infection as tested by RT-PCR/rapid antigen tests
• Able to perform a 6-minute walk test
• Blood routine, liver and kidney functions test values are within controllable range
• Adequate hepatic function as evidenced by ALT and AST \< 2X ULN and bilirubin \< 1.5X ULN for the reference lab
• 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
• Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L
• If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.

You may not qualify if:

• Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
• Clinically relevant heart condition such as, but not limited to, uncontrolled heart failure, severe pulmonary hypertension, atrial fibrillation or significant congenital heart disease
• Severe asthma on chronic therapy with biologics or steroids
• 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)
• Evidence of active malignancy, or prior history of active malignancy not in remission.
• Life expectancy of \< 6 months
• Patient included in another ongoing interventional therapeutic trial.
• Pregnant or Lactating.
• 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.

Sponsors & Collaborators

• Vitti Labs, LLC: lead

Study Sites (1)

Kit Bartalos

Liberty, Missouri, 64068, United States

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 24, 2022
• Study Start: November 30, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)