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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Efficacy and safety of high-dose vitamin C combined with traditional Chinese medicine in the treatment of moderate and severe novel coronavirus pneumonia (COVID-19)

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注册号：

Registration number：

ChiCTR2000032717 

最近更新日期：

Date of Last Refreshed on：

2020-05-10 22:22:13 

注册时间：

Date of Registration：

2020-05-08 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

高剂量维生素C联合中药方剂治疗普通和重型新型冠状病毒肺炎(COVID-19)的疗效及安全性

Public title：

Efficacy and safety of high-dose vitamin C combined with traditional Chinese medicine in the treatment of moderate and severe novel coronavirus pneumonia (COVID-19)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高剂量维生素C联合中药方剂治疗普通和重型新型冠状病毒肺炎(COVID-19)的疗效及安全性

Scientific title：

Efficacy and safety of high-dose vitamin C combined with traditional Chinese medicine in the treatment of moderate and severe novel coronavirus pneumonia (COVID-19)

研究课题代号(代码)：

Study subject ID：

 2020-YJ012

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

ChiMCTR2000003284

申请注册联系人：

贺西京 

研究负责人：

贺西京 

Applicant：

Xijing He 

Study leader：

Xijing He 

申请注册联系人电话：

Applicant telephone：

+86 17729109026

研究负责人电话：

Study leader's telephone：

+86 17729109026

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

czj0606@126.com

研究负责人电子邮件：

Study leader's E-mail：

czj0606@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

西安市高新区西太路777号

研究负责人通讯地址：

西安市高新区西太路777号

Applicant address：

777 Xitai Road, Gaoxin District, Xi'an, Shaanxi, China

Study leader's address：

777 Xitai Road, Gaoxin District, Xi'an, Shaanxi, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

西安国际医学中心医院

Applicant's institution：

Xi'an International Medical Center Hospital

研究负责人所在单位：

西安国际医学中心医院

Affiliation of the Leader：

Xi'an International Medical Center Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2020001

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

西安国际医学中心医院伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Xi'an International Medical Center Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2020-03-05 00:00:00

伦理委员会联系人：

曹新历

Contact Name of the ethic committee：

Xinli Cao

伦理委员会联系地址：

西安市高新区西太路777号

Contact Address of the ethic committee：

777 Xitai Road, Gaoxin District, Xi'an, Shaanxi, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

西安国际医学中心医院

Primary sponsor：

Xi'an International Medical Center Hospital

研究实施负责（组长）单位地址：

西安市高新区西太路777号

Primary sponsor's address：

777 Xitai Road, Gaoxin District, Xi'an, Shaanxi, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西

市(区县)：

Country：

China

Province：

Shaanxi

City：

单位(医院)：

西安国际医学中心医院

具体地址：

西安市高新区西太路777号

Institution
hospital：

Xi'an International Medical Center Hospital

Address：

777 Xitai Road, Gaoxin District, Xi'an

经费或物资来源：

陕西省中医药管理局“2020年度中医药防治新型冠状病毒感染的肺炎科研应急专项项目”，项目编号：2020-YJ012，负责人：贺西京，经费：10万元

Source(s) of funding：

A grant from Administration of Traditional Chinese Medicine of Shaanxi Province (project name: Special Fund for Scientific Research of Emergency Rescue of Novel Coronavirus-Infected Pneumonia with Tr

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

(1)观察补中益气加减方能否改善普通/重型新型冠状病毒肺炎患者的临床症状及加快恢复，并进一步研究高剂量维生素C联合中药的相应治疗方案治疗普通型/重型新型冠状病毒肺炎的临床疗效。 (2)评价高剂量维生素C联合补中益气加减方治疗普通型/重症新型冠状病毒肺炎的安全性。  

Objectives of Study：

(1)To investigate whether Buzhong Yiqi Decoction can improve the clinical symptoms of patients with mild and severe COVID-19 and accelerate recovery and to further investigate the clinical efficacy of high-dose vitamin C combined with Chinese medicine in the treatment of mild and severe COVID-19; (2)To assess the safety of high-dose vitamin C combined with Chinese medicine in the treatment of mild and severe COVID-19.

药物成份或治疗方案详述：

治疗前的检查： (1)记录年龄、性别、种族、身高、体质量、体质量指数、体温、血压、脉搏、呼吸数据资料； (2)记录既往病史、现病史、治疗史、伴随疾病/治疗史； (3)记录实验室检验：血常规、尿常规、便常规+潜血、C反应蛋白、生化全项、呼吸道病毒学检测、肿瘤标志物、大小便常规、ABO血型+RH血型资料； (4)细胞因子检测：检测血清白细胞介素6(IL-6)、IL-10、肿瘤坏死因子α(TNF-α)水平。 (5)辅助检查：胸部CT观察肺部感染征象。 5.2中药疗法包括：中药煎膏口服+中药加维生素C熏吸方+口服维生素E胶丸、叶酸 5.3中药及西药信息： 5.3.1中药疗法： 方一：补中益气加减方（不发热及康复期患者使用）： 生黄芪30g 人参15g 生甘草15g 生白术10g 陈皮6g 当归10g 大枣6枚 生姜9片 柴胡12g 升麻6g 制作方法：以上药物合并水煎，水煎液高速离心去除杂质后，浓缩50g，每25g一包 服用方法：一次一包，一日两次，温开水送服。 方二：胡黄排毒膏（发热患者使用） 生黄连20g 生大黄10g 生黄芩10g 苍术10g 紫苑10g 鱼腥草10g 蒲公英10g 虎杖10g生黄芪20g 制作方法：以上药物合并水煎，水煎液高速离心去除杂质后，浓缩50g，每25g一包 服用方法：一次一包，一日两次，温开水送服。 方三：白母清热解毒膏 葛根15g 白芷12g 辛夷9g 板蓝根30g 连翘15g 浙贝母12g 制作方法：以上药物合并水煎，水煎液高速离心去除杂质后，浓缩50g，每25g一包 服用方法：一次一包，一日两次，温开水送服。 方四：中药加维生素C熏吸方 生黄连20g 生大黄10g 生黄芩10g 苍术10g 紫菀10g 鱼腥草10g 蒲公英10g 虎杖10g 生黄芪20g 制作方法：以上药物合并水煎，水煎液高速离心去除杂质后，浓缩50g，每25g一包 熏吸方法：用全智能电饭煲（规格5L）加3L水，投入2袋制成的膏剂，煮沸后加入维生素C10g，氧气管插入中药液底部（氧气流量大约3-4L/min），用口鼻交替深吸蒸汽，每次30-40 min即可，每日3-7次。每日口服维生素E胶丸、叶酸。 5.3.2冲击量维生素C治疗：每日不小于20 g/60 kg体质量(333 mg/kg体质量，每日2次冲击量给药，1次10 g/60 kg体质量，加入5%葡萄糖100 mL静脉滴注。 5.3.3 西医治疗方法：包括α-干扰素500万U＋灭菌注射用水2 mL雾化吸入，2次/d；阿比多尔 0.2 g，3次/d，疗程不超过10 d；利巴韦林500 mg/次静点，Q12H（疗程不超过10 d）；丙种免疫球蛋白 10 g 静点，1次/d，共3-5 d；合并有细菌感染证据（黄痰、PCT等细菌感染特异性指标升高者）予以经验性抗感染治疗。 5.4病例、病程记录注意事项： 每个病例必须认真书写中西医结合病历，每3天做1次病历小结。记录所用中药、西药名称及剂量、给药途径、疗效、有无副作用等。每天填写疗效观察记录表。 

Description for medicine or protocol of treatment in detail：

5.1 Preparation prior to treatment (1) Record of age, sex, race, height, body mass, body mass index, body temperature, blood pressure, pulse, and respiratory rate; (2) Record of previous medical history, current medical history, treatment history, concomitant disease/treatment history; (3) Record of laboratory tests: routine blood test, routine stool and urine tests, fecal occult blood?test, C-reactive protein measurement, biochemical assay, PCR?testing?for?respiratory?virus, tumor marker test, and ABO typing (4) Cytokine detection: Serum levels of interleukin-6, interleukin-10, and tumor necrosis factor-alpha (TNF-α) (5) Auxiliary examination: Chest CT for assessment of lung infection 5.2Chinese medicine treatments Chinese medicine treatments include oral administration of concentrated Chinese herbal decoction (prescription 1), fumigation/inhalation of Chinese medicine and vitamin C (prescription 2), and (3) bolus administration of vitamin C (prescription 3). 5.3Traditional Chinese and western medicine prescription details 5.3.1Traditional Chinese medicine treatment details Prescription 1: Buzhong Yiqi plus and minus formula (recommended for patients who had no fever and those who are in the convalescent period): This formula is composed of Radix Astragali 30 g, Radix Ginseng 15 g, Radix Glycyrrhizae 15 g, Rhizoma Atractylodis Macrocephalae 10 g, Pericarpium Citri Reticulatae 6 g, Radix Angelicae Sinensis 10 g, Fructus Jujubae 6, Rhizoma Zingiberis Recens 9 pieces, Radix Bupleuri 12 g, Rhizoma Cimicifugae 6 g. Preparation method: The aforementioned herbs are decocted with water. After removal of macromolecules, 50 g concentrate is left, and then packaged, 25 g/dose. Suggested usage: 1 dose once, twice a day, taking with warm water. Prescription 2: Huhuang Detoxicity Paste (recommended for patients who have no fever): This formula is composed of Rhizoma Coptidis 20 g, Radix Et Rhizoma Rhei 10 g, Rhizoma Atractylodis 10 g, Radix Asteris 10 g, Herba Houttuyniae 10 g, Herba Taraxaci 10 g, Rhizoma Polygoni Cuspidati 10 g, Radix Astragali 20 g. Preparation method: The aforementioned herbs are boiled with water. The extract was subjected to high-speed centrifugation. After removal of impurities, 50 g concentrate is left, and then packaged, 25 g/dose. Suggested usage: One dose once, twice a day, taking with warm water. Prescription 3: Baimu Qingre Jiedu Paste This formula is composed of Radix Puerariae 15 g, Radix Angelicae Dahuricae 12 g, Flos Magnoliae 9 g, Radix Isatidis 30 g, Fructus Forsythiae 15 g, Bulbus Fritillariae Thunbergii 12 g Preparation method: The aforementioned herbs are boiled with water. The extract was subjected to high-speed centrifugation. After removal of impurities, 50 g concentrate is left, and then packaged, 25 g/dose. Suggested usage: One dose once, twice a day, taking with warm water. Prescription 4: Fumigation/inhalation of Chinese herbs and vitamin C The formula consists of Rhizoma Coptidis 20 g, Radix Et Rhizoma Rhei 10 g, Rhizoma Atractylodis Macrocephalae 10 g, Radix Astragali 10 g, Radix Asteris 10 g, Herba Houttuyniae 10 g, Herba Taraxaci 10 g, Rhizoma Polygoni Cuspidati 10 g, Radix Astragali 20 g. Preparation method: The aforementioned herbs are boiled with water. The extract was subjected to high-speed centrifugation. After removal of impurities, 50 g concentrate is left, and then packaged, 25 g/dose. Fumigation/inhalation method: 3L of water is added to the intelligent rice cooker (specification 5L), and then the aforementioned semifluid paste is also placed in the cooker. After boiling, 10 g vitamin C is added. The oxygen tube is inserted into the bottom of the traditional Chinese medicine solution (oxygen flow is about 3-4 L/min). The steam is sucked with the mouth and nose alternately, 30-40 minutes once, 3-7 times a day. Patients take vitamin E capsule and folic acid every day. 5.3.2 Bolus administration of vitamin C 100 mL of 5% glucose containing vitamin C (10 g/60 kg body mass) is intravenously administered twice a day. 5.3.3 Western medicine treatment details Atomized inhalation of 5 million U α-interferon and 2 mL sterilized water, twice a day; 0.2 g arbidol, three times a day, treatment course no more than 10 days; intravenous administration of ribavirin 500 mg, once every 12 hours, treatment course no more than 10 days; intravenous administration of 10 g immunoglobulin C, once a day, 3-5 days. Anti-bacterial infection treatment is given to the patients who have yellow sputum and increased levels of procalcitonin and other bacterial infection specific indicators. 5.4 Notes for case and course record The medical record of integrated Chinese and western medicine treatment for each case should be carefully filled. A summary of the medical record is made every three days. The name and dosage of the traditional Chinese medicine and western medicine used, the route of administration, curative effect, and side effects are recorded. The record form of the curative effect should be filled every day.  

纳入标准：

(1) 符合中国国家卫生健康委发布的“新型冠状病毒肺炎诊疗方案(试行第七版)”确诊诊断条件的确诊普通型和重型新型冠状病毒感染肺炎的确诊病例；
(2) 疑似病例同时具备以下病原学或血清学证据之一者为确诊病例：
①实时荧光RT-PCR检测新型冠状病毒核酸阳性；
②病毒基因测序，与已知的新型冠状病毒高度同源；
③血清新型冠状病毒特异性IgM抗体和IgG抗体阳性；
④血清新型冠状病毒特异性IgG抗体由阴性转为阳性或恢复期较急性期4倍及以上升高；
(3) 普通型患者为：具有发热、呼吸道等症状，影像学可见新型冠状病毒肺炎影像学特征；
(4) 重型患者为：成人符合下列任何一条：出现气促，呼吸频率≥30 次/min；静息状态下，指氧饱和度≤93%；动脉血氧分压(PaO2)/吸氧浓度(FiO2)运300 mmHg (1 mmHg=0.133 kPa)。肺部影像学显示24-48 h内病灶明显进展>50%者按重型管理；
(5)年龄＞18岁，性别不限；
(6)自愿签署书面的知情同意书。

Inclusion criteria

1. Patients with mild and severe COVID-19 confirmed according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7) that was issued by the National Health Commission & State Administration of Traditional Chinese Medicine;
2. Patients with suspected COVID-19 who meet one of the following pathogenic or serological evidence are also confirmed infected with the virus: a) COVID-19 nucleic acid test positive, as confirmed by real-time fluorescence RT-PCR detection; b) viral gene sequencing is highly homologous with the known COVID-19; c) serum test positive for both COVID-19 specific IgM and IgG antibodies; d) serum IgG antibody turns positive from negative or IgG antibody level in the recovering phase rises four times or higher than in the acute phase;
3. Patients with moderate COVID-19 have fever and respiratory symptoms and present with the imaging features of coronavirus disease;
4. Subjects will be considered developing severe COVID-19 if one of the following conditions occur:
dyspnea, respiratory >=30 beats/minute, blood oxygen saturation <=93%, partial pressure of arterial oxygen (PaO2)/ fraction of inspired oxygen ratio (FiO2) <=300, and /or lung infiltrates >50% within 24 to 48 hours
5. Aged > 18 years;
6. Provision of written informed consent.

排除标准：

(1)危重症新型冠状病毒肺炎患者，出现休克、急性呼吸窘迫综合症、多脏器功能衰竭者；
(2)轻型新型冠状病毒肺炎患者；
(3)妊娠期和哺乳期妇女；
(4)经研究者判断，既往或现在患有的疾病，可能影响患者参加试验或影响研究的转归，包括：恶性病、自身免疫性疾病、严重营养不良、肝肾疾患、血液病、神经系统疾病、和内分泌疾病；现患有严重影响免疫系统的疾病，如：人类免疫缺陷病毒(HIV)感染，或血液系统，或脾切除和器官移植等；
(5)?研究者或申办者认为患有其他急性严重或慢性医学或心理疾病、不适合参加本组临床试验者。

Exclusion criteria：

(1) Patients with critical COVID-19 presenting with shock, acute respiratory distress syndrome, multiple organ failure;
(2) Patients with mild COVID-19;
(3) Pregnant or lactating woman;
(4) Upon the investigators judgment, patients had the diseases that possibly influence patient participation in this study or study outcomes (such as malignant disease, autoimmune disease, severe malnutrition, liver and kidney disease, blood disease, nervous system disease, endocrine diseases) or currently suffer from the diseases that seriously affect the immune system (such as human immunodeficiency virus infection) or blood system, or splenectomy/organ transplantation;
(5) Upon the request of the investigators or sponsors, patients with other acute malignant or chronic disease or mental disorder are not suitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2020-02-06 00:00:00至 To 2021-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-02-12 00:00:00 至 To 2020-03-31 00:00:00  

干预措施：

Interventions：

组别：

对照组1

样本量：

10

Group：

Control group 1

Sample size：

干预措施：

西医治疗

干预措施代码：

Intervention：

western medicine treatment

Intervention code：

组别：

中西医治疗组1

样本量：

10

Group：

Integrated traditional Chinese and western medicine treatment group 1

Sample size：

干预措施：

西医治疗+中药疗法+5%葡萄糖静滴(对照)b

干预措施代码：

Intervention：

(2)traditional Chinese medicine treatment, western medicine treatment, and intravenous administration of 5% glucose (control)

Intervention code：

组别：

中西医治疗+高剂量维生素C组1

样本量：

10

Group：

Integrated traditional and western medicine treatment + high-dose vitamin C group 1

Sample size：

干预措施：

西医治疗+中药疗法+高剂量维生素C静滴

干预措施代码：

Intervention：

traditional Chinese medicine treatment, western medicine treatment, and intravenous administration of high-dose vitamin C (control)

Intervention code：

组别：

对照组2

样本量：

10

Group：

Control group 2

Sample size：

干预措施：

西医治疗

干预措施代码：

Intervention：

western medicine treatment

Intervention code：

组别：

中西医治疗组2

样本量：

10

Group：

Integrated traditional and western medicine treatment group 2

Sample size：

干预措施：

西医治疗+中药疗法+5%葡萄糖静滴(对照)

干预措施代码：

Intervention：

(5)traditional Chinese medicine treatment, western medicine treatment, and intravenous administration of 5% glucose (control)

Intervention code：

组别：

中西医治疗+高剂量维生素C组2

样本量：

10

Group：

Integrated traditional and western medicine treatment + high-dose vitamin C group 2

Sample size：

干预措施：

西医治疗+中药疗法+高剂量维生素C静滴

干预措施代码：

Intervention：

(6)traditional Chinese medicine treatment, western medicine treatment, and intravenous administration of high-dose vitamin C (control)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China 

Province：

Shaanxi 

City：

 

单位(医院)：

西安国际医学中心医院 

单位级别：

三甲医院 

Institution
hospital：

Xi'an International Medical Center Hospital

Level of the institution：

Tertiary A Hospital

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

武汉市第八医院 

单位级别：

三甲医院 

Institution
hospital：

The Eighth Hospital of Wuhan

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

疾病恢复时间

指标类型：

主要指标

Outcome：

Recovery time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

主要症状消失率及消失时间

指标类型：

次要指标

Outcome：

The rate and time of disappearance of major symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

新型冠状病毒转阴时间及转阴率

指标类型：

次要指标

Outcome：

The rate of conversion from COVID-19 positive to COVID-19 negative

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

入院到胸部CT明显好转时间及比率

指标类型：

次要指标

Outcome：

The time and rate of obvious improvement as shown on chest CT scans relative to admission

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血气分析指标

指标类型：

次要指标

Outcome：

Blood gas analysis indexes

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室检验指标

指标类型：

次要指标

Outcome：

Laboratory test indicators

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫指标变化

指标类型：

次要指标

Outcome：

Change in immune indexes

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

泌尿系超声检查

指标类型：

次要指标

Outcome：

Ultrasound examination of the urinary system

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

咽拭子

组织：

Sample Name：

nasopharyngeal swabs

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

痰液

组织：

Sample Name：

sputum

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

feces

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用分层区段随机化方法。应用SAS9.4统计软件编程，给定种子数，设定区段长度，产生30例受试者所接受处理(试验组和安慰剂对照)的随机安排，即列出流水号为01—30所对应的治疗分配(即随机编码表)。所设定的区组长度及种子数等参数记录在盲底中

Randomization Procedure (please state who generates the random number sequence and by what method)：

Stratified randomization method is adopted. SAS version 9.4 software is used. The number of seeds and the length of block are defined. A random sequence for 30 patients with COVID-19 who are allocated to a study group or a placebo control group is generated, that is the treatment allocation (a rando

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

(1)由生物统计专业以及与本临床试验无关的人员完成试验用药物的编盲及应急卡片准备工作，并进行编盲，随机编码表及其相应的参数均记录在盲底中。分药结束后，编盲人员在盲底信封骑缝处签字。 (2)试验采用两级盲底设计，第一级为编号所对应的干预代码即干预A或干预B,第二级为每个代码所对应的组别为何种干预。两级盲底存放在天津昂赛细胞基因工程有限公司，保存直至揭盲完成，试验期间盲底不得拆阅。

Blinding：

(1)The biostatisticians and the personnel unrelated to the clinical trial complete the binding of the study drugs and emergency card preparation. The random coding table and corresponding parameters are recorded blindly. After drug designation, the personnel responsible for blinding of the study drugs will sign at the perforation of the blinding envelope. A two-level blinding design will be adopted. The first-level code corresponds to intervention A or intervention B, and the second-level code presents the corresponding group. The envelope containing two-level blinding file will be preserved in Tianjin Angsai Cell Gene Engineering Co., Ltd., China until unblinding. The unblinding will not be performed during the study period.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

研究结果将在同行评议期刊或以会议报告形式发表，出版数据将公开发布于www.figshare.com

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Trial results will be published in peer-reviewed journals or in meeting reports. Anonymized trial data will be available indefinitely at www.figshare.com

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

(1) 数据收集：患者病历作为临床试验的原始文件，应完整保存。病例报告表(CRF)中的数据来自原始文件并与原始文件一致，研究者必须保证数据真实、完整、准确。临床试验记录表上所有项目均需填写，不得空项、漏项(无记录的空格划斜线)；做任何更正时只能划线，旁注改后的数据，说明理由，由记录者签名并注明日期，不得擦涂、覆盖原始记录。 (2) 数据管理：所有原始资料、文件、实验报告、总结报告和应作为临床试验研究的结果保存于电子采集和管理系统(Electronic Data Capture, EDC)，应由档案室有序地贮存，可迅速检索并方便地得到所有原始资料、实验报告、试验方案及总结报告。应指定专人负责档案室的管理。未经批准，不得进入档案室。在档案室中保存或参考的资料应做成索引以方便检索。为保护受试者隐私，病例报告表上不应出现受试者的姓名。研究者应按受试者的代码确认其身份并记录。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

(1)Data collection: Patient medical record as the original file of the clinical trial will be completely preserved. The data of case report form will be the same as those in the original file. The data should be recorded truly, completely and correctly. All items on the clinical trial records should be filled in. The blank space without record should be slashed. If case of any correction, only the underline will be applied, and the modified data and explainable reasons will be left in the comments and signed. (2)Data management: All original data, files, experimental reports, summary reports, and clinical trial results will be kept in the Electronic Data Capture (EDC). It will be stored in an orderly manner in the archives room for quick retrieval. A special person will be appointed to manage the archives. Nobody can enter the archive room without permission. To protect the privacy of the subjects, the name of the subjects will not appear on the case report form. The investigator will identify the subjects according to the code.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-05-08 09:52:02
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