Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.
研究概览
简要总结
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.
详细描述
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):
- Experimental/treatment arm: VL-PX10 and VL-P22 plus standard care
- Placebo: Saline plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Experimental/treatment arm
干预措施: VL-PX10 and VL-P22 plus standard care (Drug)
结局指标
主要结局
Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.
时间窗: 3 months
Presence of adverse events in less than 10% of the study population, as a measure of safety
To evaluate the efficacy of VL-PX10 and VL-P22 administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo.
时间窗: 3 months
Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.
次要结局
- Incidence of Re-Hospitalization(3 months)
- Change in Pulse Oximetry During the 6MWT(3 months)
- Quality of Life assessment as collected using the SF-36(3 months)