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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

A II/III clinical study to evaluate the efficacy and safety of YKYY017 for inhalation in the treatment of patients with mild to moderate COVID-19 infection

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注册号：

Registration number：

ChiCTR2300075467 

最近更新日期：

Date of Last Refreshed on：

2025-12-25 15:15:45 

注册时间：

Date of Registration：

2023-09-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价 YKYY017 雾化吸入剂在治疗轻中度新型冠状病毒感染患者中的疗效和安全性的II/III期临床研究

Public title：

A II/III clinical study to evaluate the efficacy and safety of YKYY017 for inhalation in the treatment of patients with mild to moderate COVID-19 infection

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价 YKYY017 雾化吸入剂在治疗轻中度新型冠状病毒感染患者中的疗效和安全性的II/III期临床研究

Scientific title：

A II/III clinical study to evaluate the efficacy and safety of YKYY017 for inhalation in the treatment of patients with mild to moderate COVID-19 infection

研究课题代号(代码)：

Study subject ID：

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：

申请注册联系人：

周玉婷 

研究负责人：

王辰,曹彬 

Applicant：

Zhou Yuting 

Study leader：

Wang Chen,Chao Bin 

申请注册联系人电话：

Applicant telephone：

+86 186 0641 7018

研究负责人电话：

Study leader's telephone：

+86 10 8420 6086

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：

zhouyuting@bjykkc.com

研究负责人电子邮件：

Study leader's E-mail：

Caobin123@163.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：

北京市经济技术开发区宏达中路6号

研究负责人通讯地址：

北京朝阳区樱花东街2号

Applicant address：

6 Hongda Middle Road, EconomicTechnological Development Area, Beijing

Study leader's address：

2 Yinghua East Street, Chaoyang District,Beijing

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：

悦康药业集团股份有限公司

Applicant's institution：

YouCare Pharmaceutical Co.,Ltd.

研究负责人所在单位：

中日友好医院

Affiliation of the Leader：

China-Japan Friendship 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：

YW2023-043-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中日友好医院药物（器械）临床试验伦理委员会

Name of the ethic committee：

Ethics Committee of Drug (Equipment) Clinical Trials of China-Japan Friendship Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2023-06-02 00:00:00

伦理委员会联系人：

崔勇

Contact Name of the ethic committee：

Cui Yong

伦理委员会联系地址：

北京朝阳区樱花园东街2号

Contact Address of the ethic committee：

2 Yinghua East Street, Chaoyang District,Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8420 6086

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：

中日友好医院

Primary sponsor：

China-Japan Friendship Hospital

研究实施负责（组长）单位地址：

北京朝阳区樱花园东街2号

Primary sponsor's address：

2 Yinghuayuan East Street, Chaoyang District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中日友好医院

具体地址：

北京朝阳区樱花园东街2号

Institution
hospital：

China-Japan Friendship Hospital

Address：

2 Yinghuayuan East Street, Chaoyang District, Beijing

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

悦康药业集团股份有限公司

具体地址：

经济技术开发区宏达中路6号

Institution
hospital：

Youcare Pharmaceutical Group Co, Ltd.

Address：

6 Hongda Middle Road, Economic Technological Development Area, Beijing

经费或物资来源：

悦康药业集团股份有限公司

Source(s) of funding：

Provided by Youcare Pharmaceutical Group Co, Ltd.

Target disease：

COVID-19 infection

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II-III期临床试验 

Study phase：

2-3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价YKYY017雾化吸入剂在治疗轻中度新型冠状病毒感染（COVID-19） 患者中的疗效和安全性。  

Objectives of Study：

Evaluate the efficacy and safety of YKYY017 for inhalation on the treatment of patients with mild to moderate COVID-19 infection.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 受试者签署知情同意书（ICF）时的年龄≥ 18周岁且≤ 75周岁。 2. 受试者具有至少一个COVID-19相关的指定发热或呼吸道症状（发热，咳嗽，咽喉痛，鼻塞或流涕，气促或呼吸困难，畏寒或寒战），且症状评分总分≥ 2分（COVID-19相关症状评分量表）。 3. 首次出现症状（14个COVID-19相关症状的首个症状出现时间）距首次给予试验用药品≤ 72 h。 4. 受试者筛选时SARS-CoV-2病毒核酸检测或快速抗原检测阳性。 5. 轻度或中度COVID-19（疾病严重程度参考附录二）。 6. 受试者同意从签署知情同意书至末次给药后至少30天（适用育龄期女性）或90天（适用成年男性）采取有效的避孕措施。 7． 受试者了解并同意遵守计划的研究程序（包括治疗计划、访视安排、实验室检查、生活方式注意事项等），且受试者或合法授权人愿意签署书面的ICF

Inclusion criteria

1. The age of the subjects at the time of signing the informed consent form (ICF) should be >= 18 years and <= 75 years. 2. The subjects should have at least one designated fever or respiratory symptom related to COVID-19 (fever, cough, sore throat, nasal congestion or runny nose, shortness of breath or difficulty breathing, chills or shivering), and the total score of the symptoms should be >= 2 points (COVID-19-related symptom scoring scale). 3. The time from the first appearance of symptoms (the first symptom of the 14 COVID-19-related symptoms) to the first administration of the investigational drug should be <= 72 hours. 4. The subjects should have a positive nucleic acid test or rapid antigen test for SARS-CoV-2 virus at the time of screening. 5. Mild or moderate COVID-19 (the severity of the disease is referred to in Appendix II). 6. The subjects agree to take effective contraceptive measures from the time of signing the informed consent form to at least 30 days after the last dose (applicable to women of childbearing age) or 90 days (applicable to adult men). 7.The subjects understand and agree to comply with the planned research procedures (including treatment plan, visit schedule, laboratory tests, lifestyle precautions, etc.), and the subjects or their legally authorized representatives are willing to sign the written ICF.

排除标准：

1. 研究者判断在随机分组前受试者即将进展为重度/危重度COVID-19。 2. 受试者静息状态室内空气下脉搏血氧饱和度（SpO2）≤ 93%，或动脉血氧分压（PaO2）/吸氧浓度（FiO2）≤ 300（如需），或呼吸频率≥ 30次/分钟。 3. 研究者评估受试者急需或预期需要经鼻高流量氧疗或无创正压通气、有创机械通气或ECMO。 4. 受试者正在使用或拟使用其他的SARS-CoV-2抗病毒药物，或恢复期COVID-19血浆治疗，或研究者认为与本研究在科学或医学上不兼容的任何其他类型的治疗措施。 5. 受试者在过去30天内参加过涉及研究药物干预的临床研究。如果既往研究药物干预的半衰期较长，则应经过5个半衰期或30天（以较长者为准）。 6. 受试者随机前3个月内接种过任何COVID-19疫苗，或3个月内曾经感染过新型冠状病毒。 7. 已知存在慢性肝脏疾病（Child-Pugh分级B或C）；或已知存在慢性肾脏疾病（CKD分期≥ 4期）。 8. 受试者存在任何需要在随机前14天内进行手术的合并症，或在随机前30天内研究者认为有危及生命的合并症，或近3个月内做过II级以上手术。 9. 对研究干预的任何成分有过敏反应或其他禁忌症。 10. 已知受试者患严重的慢性呼吸系统疾病[既往诊断慢性阻塞性肺疾病 GOLD E级，未控制哮喘或需要吸入高剂量糖皮质激素控制的哮喘，既往已知间质性肺疾病或肺动脉高压等慢性呼吸系统疾病活动后出现呼吸困难]，或已知存在免疫系统受损状态[自身免疫性疾病活动期，或正在使用可导致免疫抑制的药物，或免疫缺陷（如恶性肿瘤、器官或骨髓移植、HIV感染等），以及其他可引起免疫系统受损的疾病]，或除COVID-19以外的疑似或确诊的急性全身性感染（如流感、败血症、系统性真菌病等），或提示COVID-19导致重度全身性疾病的临床症状/体征。 11. 筛选时受试者患未治愈的急性疾病，或处于慢性疾病的急性发作期，或患严重慢性病[包括心脑血管疾病：3个月内因急性心脑血管事件而住院的受试者，包括脑卒中、急性冠脉综合征（急性心肌梗死和不稳定性心绞痛等）、或经研究者判断慢性心脑血管疾病影响生活功能无法配合研究随访的情况（如严重瘫痪、NYK III级及以上）、高血压：高血压急症或高血压危险以及其他筛查时发现需要立刻住院诊疗的高血压状况、活动性恶性肿瘤性疾病：半年内接受放化疗的恶性肿瘤性疾病，不包括单纯靶向治疗的情况（如EGFR突变靶向治疗情况）、风湿免疫性疾病：3个月内使用生物制剂的免疫抑制剂（CD20单抗、TNF抑制剂等），以及环磷酰胺、吗替麦考酚酯（超过0.5 mg bid）、糖皮质激素（超过泼尼松20 mg qd持续1个月）、严重肝肾功能异常：Child分级C级以上，CKD 5期维持性血液透析、血栓性疾病、神经系统疾病、血液和淋巴系统疾病、胃肠道疾病、呼吸系统疾病、精神疾病、代谢性疾病以及肌肉骨骼疾病等]。 12. 女性受试者在此研究期内怀孕或哺乳或计划怀孕，男性受试者的妻子或伴侣计划在此研究期内怀孕。 13. 研究者评估受试者不适合参与本研究的其他情况，或研究者认为会损害受试者安全的任何医疗状况。

Exclusion criteria：

1. The researcher determined that the subject was about to progress to severe/critical COVID-19 before randomization. 2. The subject's pulse oxygen saturation (SpO2) at rest in room air was <= 93%, or the arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) was <= 300 (if necessary), or the respiratory rate was >= 30 breaths per minute. 3. The researcher assessed that the subject urgently needed or was expected to need nasal high-flow oxygen therapy or non-invasive positive pressure ventilation, invasive mechanical ventilation, or ECMO. 4. The subject was using or was scheduled to use other SARS-CoV-2 antiviral drugs, or convalescent plasma therapy for COVID-19, or any other type of treatment measure that the researcher considered incompatible with this study in terms of science or medicine. 5. The subject had participated in a clinical study involving drug intervention within the past 30 days. If the half-life of the previous study drug intervention was long, a period of 5 half-lives or 30 days (whichever was longer) should have elapsed. 6. The subject had received any COVID-19 vaccine within the 3 months prior to randomization, or had been infected with the novel coronavirus within the past 3 months. 7. Known to have chronic liver disease (Child-Pugh grade B or C); or known to have chronic kidney disease (CKD stage >= 4). 8. The subject had any comorbidities that required surgery within 14 days before randomization, or had life-threatening comorbidities within 30 days before randomization as determined by the researcher, or had undergone surgery of grade II or above within the past 3 months. 9. Had an allergic reaction to any component of the study intervention or other contraindications. 10. Known to have severe chronic respiratory diseases [previously diagnosed chronic obstructive pulmonary disease GOLD E stage, uncontrolled asthma or asthma requiring high-dose inhaled glucocorticoids for control, previously known interstitial lung disease or pulmonary arterial hypertension and other chronic respiratory diseases with dyspnea after activity], or known to have an immunocompromised state [active autoimmune disease, or using drugs that can cause immunosuppression, or immunodeficiency (such as malignant tumors, organ or bone marrow transplantation, HIV infection, etc.), and other diseases that can cause immunocompromise], or suspected or confirmed acute systemic infections other than COVID-19 (such as influenza, sepsis, systemic fungal disease, etc.), or clinical symptoms/signs suggesting severe systemic disease caused by COVID-19. 11. At the time of screening, the subject had an acute disease that had not been cured, or was in the acute phase of a chronic disease, or had a serious chronic disease [including cardiovascular and cerebrovascular diseases: subjects who were hospitalized due to acute cardiovascular and cerebrovascular events within 3 months, including stroke, acute coronary syndrome (acute myocardial infarction and unstable angina pectoris, etc.), or chronic cardiovascular and cerebrovascular diseases that affected life functions and could not cooperate with the study follow-up as determined by the researcher (such as severe paralysis, NYK grade III and above), hypertension: hypertensive emergency or hypertensive crisis and other hypertension conditions that required immediate hospitalization at the time of screening, active malignant tumor diseases: malignant tumor diseases that received radiotherapy or chemotherapy within 6 months, excluding cases of simple targeted therapy (such as EGFR mutation targeted therapy), rheumatic immune diseases: used immunosuppressants such as biological agents (CD20 monoclonal antibodies, TNF inhibitors, etc.) within 3 months, as well as cyclophosphamide, mycophenolate mofetil (more than 0.5 mg bid), glucocorticoids (more than 20 mg prednisone qd for 1 month), severe liver and kidney function abnormalities: Child grade C or above, CKD stage 5 maintenance hemodialysis, thrombotic diseases, neurological diseases, blood and lymphatic system diseases, gastrointestinal diseases, respiratory diseases, mental disorders, metabolic diseases, and musculoskeletal diseases, etc. 12. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period, or whose male partners are planning to become pregnant during the study period. 13.Other situations where the investigator assesses that the subject is not suitable for participation in this study, or any medical condition that the investigator believes would harm the subject's safety.

研究实施时间：

Study execute time：

从 From 2023-09-06 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-09-21 00:00:00 至 To 2026-10-01 00:00:00  

干预措施：

Interventions：

组别：

YKYY017 雾化吸入剂1组（第一阶段）

样本量：

80

Group：

YKYY017 for inhalation group 1 (The first stage)

Sample size：

干预措施：

YKYY017 雾化吸入剂通过雾化吸入途径给药，每日试验药物1次，安慰剂1次

干预措施代码：

Intervention：

YKYY017 for inhalation: administered via aerosol inhalation one dose of the study drug, one dose of placebo

Intervention code：

组别：

YKYY017雾化吸入剂2组（第一阶段）

样本量：

80

Group：

YKYY017 for inhalation group 2 (The first stage)

Sample size：

干预措施：

YKYY017 雾化吸入剂通过雾化吸入途径给药，每日试验药物2次

干预措施代码：

Intervention：

YKYY017 for inhalation: administered via aerosol inhalation the study drug twice daily

Intervention code：

组别：

安慰剂组1（第一阶段）

样本量：

80

Group：

Placebo 1 (The first stage)

Sample size：

干预措施：

YKYY017 雾化吸入安慰剂通过雾化吸入途径给药2次

干预措施代码：

Intervention：

A placebo of YKYY017 for inhalation was administered via aerosol inhalation,twice daily

Intervention code：

组别：

YKYY017雾化吸入剂3组（第二阶段）

样本量：

520

Group：

YKYY017 for inhalation group 3 (The second stage)

Sample size：

干预措施：

YKYY017 雾化吸入剂通过雾化吸入途径给药（给药剂量由本研究第一阶段（II期）研究结果确定）

干预措施代码：

Intervention：

YKYY017 for inhalation was administered via aerosol inhalation (dosage was determined based on Phase II (first stage) study results)

Intervention code：

组别：

安慰剂组2（第二阶段）

样本量：

520

Group：

Placebo 2 (The second stage)

Sample size：

干预措施：

YKYY017 雾化吸入安慰剂通过雾化吸入途径给药

干预措施代码：

Intervention：

A placebo of YKYY017 for inhalation was administered via aerosol inhalation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中日友好医院  

单位级别：

三甲 

Institution
hospital：

China-Japan Friendship Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

从开始治疗至持续临床恢复的时间

指标类型：

主要指标

Outcome：

The period from the beginning of treatment to the complete clinical recovery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SARS-CoV-2病毒载量较基线的变化

指标类型：

次要指标

Outcome：

The change in viral load compared to the baseline of the SARS-CoV-2

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

开始治疗后的SARS-CoV-2病毒核酸转阴率

指标类型：

次要指标

Outcome：

The rate of negative conversion of SARS-CoV-2 viral nucleic acid after the start of treatment

Type：

Secondary indicator

测量时间点：

测量方法：

咽拭子

Measure time point of outcome：

Measure method：

Pharyngeal test

指标中文名：

SARS-CoV-2病毒载量的反弹率

指标类型：

次要指标

Outcome：

The rebound rate of SARS-CoV-2 viral load

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

粘液病毒抗性蛋白A（MxA）的表达水平较基线的变化

指标类型：

次要指标

Outcome：

The change in the expression level of MxA compared to the baseline

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从开始治疗至持续症状缓解的时间

指标类型：

次要指标

Outcome：

The period from the beginning of treatment until the complete relief of 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：

每个COVID-19相关症状从开始治疗到持续临床恢复的时间

指标类型：

次要指标

Outcome：

The duration from the onset of each COVID-19-related symptom to the complete clinical recovery

Type：

Secondary indicator

测量时间点：

测量方法：

血液

Measure time point of outcome：

Measure method：

指标中文名：

受试者D1~D28期间的COVID-19相关症状评分变化

指标类型：

次要指标

Outcome：

The changes in the COVID-19-related symptom scores of subjects D1 to D28

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者D1~D28期间的疾病进展（发展为重度或危重度或全因死亡）的病例数和比例

指标类型：

次要指标

Outcome：

The number and proportion of cases where the subjects D1 to D28 experienced disease progression (developed to severe or critical severity or died from all causes) during the observation period

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

COVID-19相关症状（11个症状）的反弹率

指标类型：

次要指标

Outcome：

The rebound rate of COVID-19-related symptoms (11 symptoms)

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：

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：

鼻咽部分泌物

组织：

Sample Name：

Nasopharyngeal secretions

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

随机化

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

Randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲法

Blinding：

double blinding

是否共享原始数据：

IPD sharing

Yes

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）：

国家生物信息中心 https://ngdc.cncb.ac.cn/gsub/ 研究结束后12个月

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

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/) 12 months after the end of the study

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-09-06 09:58:28
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