NCT04366830No Longer Available不适用
Intermediate-size Expanded Access of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells for Acute Respiratory Distress Syndrome Due to COVID-19 Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).
详细描述
This intermediate-size expanded access protocol plans to treat approximately 50 adult participants, male and female, with moderate to severe ARDS due to COVID-19 infection. Participants who are 18 years of age or older will be enrolled at multiple clinical sites across the United States.
研究设计
- 研究类型
- Expanded Access
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
- •18 years or older
- •Participant has coronavirus disease COVID-19 confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or another diagnostic test
- •Moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria):
- •Bilateral opacities must be present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
- •Respiratory failure not fully explained by cardiac failure or fluid overload. An objective assessment (e.g., echocardiography) to exclude hydrostatic pulmonary edema is required if no risk factors for ARDS are present.
- •Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
- •Moderate ARDS: e PaO2/FiO2 >100 millimeters of mercury (mmHg) and ≤200 mmHg, on ventilator settings that include positive end-expiratory pressure (PEEP) ≥5 centimeters (cm) of water OR
- •Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm of water
- •≤72 hours post-initiation of ventilation
- •High sensitivity C-reactive protein (hs-CRP) serum level ≥ 4.0 milligrams per deciliter (mg/dL)
- •Acute Physiologic and Chronic Health Evaluation (APACHE II) score ≥5
- •Aspartate aminotransferase/alanine transaminase (AST/ALT) < 5x upper limit of normal (ULN)
- •Creatinine clearance ≥ 30 milliliters per minute (mL/min)
- •Serum creatinine <2 mg/dL
排除标准
- •Participant is receiving extracorporeal membrane oxygenation (ECMO)
- •Females who are pregnant or lactating
- •Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
- •Severe chronic obstructive pulmonary disease (COPD) requiring oxygen therapy prior to becoming ill with ARDS due to COVID-19 infection
- •Any end-stage organ disease which, in the opinion of the treating physician, may possibly affect the safety of the remestemcel-L treatment
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)NCT04456439Mesoblast International Sàrl
Unknown
不适用
Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 SyndromePost COVID-19 SyndromeNCT04798066Hope Biosciences Research Foundation
Approved For Marketing
不适用
An Intermediate Size Expanded Access Protocol of AMX0035 for ALSAmyotrophic Lateral SclerosisNCT05286372Amylyx Pharmaceuticals Inc.
No Longer Available
不适用
A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSDPost Traumatic Stress DisorderNCT04438512Lykos Therapeutics
Available
不适用
Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)Spinocerebellar AtaxiasSCANCT06034886Biohaven Pharmaceuticals, Inc.