A Stratified Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase I/IIa Clinical Trial to Assess the Safety and Efficacy of a Single Intravenous Dose of Isolated, Placental, Mesenchymal Stem Cell-derived Extracellular Vesicles for the Treatment of COVID-19 Symptoms in Adults With Mild to Moderate Illness
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
研究概览
简要总结
Investigational New Drug trial investigating safety as primary endpoint and clinical efficacy as secondary endpoint of placental, mesenchymal stem cell-derived extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.
详细描述
The study is a prospective, stratified, randomized, double-blinded, placebo-controlled, parallel-group, single-dose clinical study with the primary objective of evaluating the safety of XoGlo® PRO (isolated, placental mesenchymal stem cell [MSC]-derived extracellular vesicles [EVs]) administered intravenously (IV) for the treatment of Coronavirus Disease 2019 (COVID-19) symptoms in adults with mild-to-moderate illness. The secondary objective of the study is to evaluate the efficacy of treatment between the XoGlo® PRO treatment arm and the placebo arm.
Primary and secondary objectives will be evaluated overall and stratified by time between COVID-19 symptom onset and treatment administration (symptomatic days prior to dose), age, sex, and vaccination status.
The time from the onset of COVID-19 symptoms to single-dose treatment must be greater than 2 days but no more than 10 days. Four (4) symptom-time cohorts are defined based on the time from symptom onset to single-dose treatment administration: 3-4 days, 5-6 days, 7-8 days, and 9-10 days. Each symptom-time cohort will include 16 subjects (8 XoGlo® PRO treatment arm subjects and 8 placebo arm subjects). Vaccination status between the treatment arms and symptom-time cohorts will be balanced using stratified randomization.
As defined by the Centers for Disease Control and Prevention (CDC), vaccination status will be categorized into four groups:
Optimally Protected: A person is considered optimally protected when fully vaccinated and up to date with recommended booster doses, if eligible.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects of either gender aged more than 18 years.
- •Body Mass index (BMI) between ≥25 and ≤39.9 kg/m
- •Duration (in days) of COVID-19 symptoms prior to randomization is a > 2 days and ≤ 10 days of COVID-19 symptoms.
- •Two (2) positive (rapid) antigen diagnostic tests for SARS-CoV-2 (tests listed under FDA EUA) and administered within 2 hours of each other. Enrolled subjects will undergo subsequent molecular standard reverse transcriptase polymerase chain reaction (rt-PCR) assay. Enrolled subjects with a negative PCR test will be replaced by other individuals.)
- •Subjects with a minimal baseline severity score for COVID-19-related symptoms defined as at least two symptoms with a score of 2 or higer, using normalized grading scale.
- •Female subjects of non-childbearing potential (e.g., non fertile, pre-menarche, permanently sterile [e.g., underwent hysterectomy, bilateral salpingectomy or bilateral ovariectomy] or post-menopausal [history of no menses for at least 12 months without an alternative medical cause] or Woman of childbearing potential* with a negative serum or urine pregnancy test
排除标准
- •Subjects who test positive for SARS-CoV-2 using a virologic test but have no symptoms consistent with COVID-
- •(Asymptomatic or presymptomatic infection).
- •Subjects who have SpO2 <94% on room air at sea level (Severe illness).
- •Subjects who have respiratory failure (Critical illness).
- •Subjects who have septic shock (Critical illness).
- •Subjects who have multiple organ dysfunction (Critical illness).
- •Subjects presenting with an underlying medical condition or risk factor that conclusively disposes that subject to a higher risk for progression to severe COVID-19, as per the CDC's Systematic Review Process.
- •Subjects hospitalized within the previous 15 days.
- •Subjects discharged from the Emergency Room within the previous 15 days.
- •Subjects not expected to survive for three (3) months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases.
- •Less than 18 years.