Monash Children's Hospital, Melbourne, Australia.
Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Australia.
Trials. 2020 Jun 4;21(1):474. doi: 10.1186/s13063-020-04387-y.
Objective: To undertake a pilot, feasibility RCT of umbilical cord blood derived cell therapy for treatment of adult patients infected with SARS-CoV-2 virus related moderate-to-severe pneumonia to prevent progression to severe ARDS.
Expanded cord blood derived cell therapy will be feasible, well tolerated and show potential efficacy in the treatment of acute COVID-19 related moderate to severe pneumonia in adult patients because of their powerful anti-inflammatory and immunomodulatory properties.
Pilot, parallel design randomised controlled trial.
The trial will recruit 24 hospitalised patients with confirmed SARS-CoV-2 infection and pneumonia from July to December 2020 at Monash Medical Centre in Melbourne, Australia.
Intervention: Intravenous injection of expanded umbilical cord blood cells at a dose of 5 million cells/kg (maximum dose - 500 million cells). Cell infusion will occur over 30-60 minutes through a peripheral intravenous cannula. Standard supportive care will continue as needed. Comparator: Standard supportive care.
Safety and tolerability of cell administration within first 24 hours of administration; clinical improvement on a seven-category clinical improvement ordinal scale.
Randomisation will be done using computer generated allocation to intervention/ control groups in a 1:1 ratio (in blocks of 6) using sealed opaque envelopes.
BLINDING (MASKING): This will be an unblinded study, given that it is the first study using expanded cord blood cells in COVID-19 patients. There will be no placebo infusion.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Twelve participants in each group. Total n=24.
CBC-19 protocol v2, dated 23 April 2020. Recruitment has not started yet. Estimated recruitment timeline is between 1st July - 31st December 2020.
Australian New Zealand Clinical Trials Registry, ACTRN12620000478910, registered 16th April 2020.
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
旨在开展一项脐带血衍生细胞治疗治疗成人感染 SARS-CoV-2 病毒相关中度至重度肺炎以预防进展为严重急性呼吸窘迫综合征的初步、可行性 RCT。
扩展的脐带血衍生细胞治疗在治疗成人急性 COVID-19 相关中度至重度肺炎方面将是可行的、耐受良好且具有潜在疗效的，因为它们具有强大的抗炎和免疫调节特性。
初步、平行设计随机对照试验。
该试验将从 2020 年 7 月至 12 月在澳大利亚墨尔本莫纳什医疗中心招募 24 名确诊 SARS-CoV-2 感染和肺炎的住院患者。
干预措施：静脉注射 500 万个细胞/kg（最大剂量-5 亿个细胞）的扩增脐带血细胞。细胞输注将通过外周静脉插管在 30-60 分钟内完成。标准支持性护理将根据需要继续进行。对照组：标准支持性护理。
细胞给药后 24 小时内给药的安全性和耐受性；根据 7 级临床改善 ordinal 量表的临床改善。
将使用计算机生成的分配方案，按 1:1 比例（分 6 个块）对干预/对照组进行随机分组，使用密封不透明信封。
盲法（掩蔽）：这将是一项非盲研究，因为这是首次在 COVID-19 患者中使用扩增脐带血细胞。不会进行安慰剂输注。
随机分组人数（样本量）：每组 12 名参与者。总 n=24。
CBC-19 方案 v2，日期为 2020 年 4 月 23 日。尚未开始招募。估计招募时间表为 2020 年 7 月 1 日至 12 月 31 日。
澳大利亚和新西兰临床试验注册中心，ACTRN12620000478910，于 2020 年 4 月 16 日注册。
完整方案作为附加文件附在试验网站上（附加文件 1）。为了加快传播这一材料，熟悉的格式已被删除；本函是完整方案的主要内容摘要。
