Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
VL-PX10 and VL-P22 plus standard care
+ Placebo
Fibrosis+3
+ Enfermedades del pulmón
+ Procesos Patológicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 30 de noviembre de 2022
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 25 a 90 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación