NCT05387239

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vitti Labs, LLC · Industry
• Sex: All
• Age: 25 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pulmonary Fibrosis
• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
DRUG	VL-PX10 and VL-P22 plus standard care	The treatment consists of administration of VL-P22 and VL-PX10 plus standard care
DRUG	Placebo	Saline plus standard care

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2022-05-24
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study