今天是:2022-08-12 星期五

In vivo use of ivermectin (IVR) for treatment for corona virus infected patients (COVID-19): a randomized controlled trial
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注册号:

Registration number:

ChiCTR2000033627 

最近更新日期:

Date of Last Refreshed on:

2020-07-09 

注册时间:

Date of Registration:

2020-06-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

In vivo use of ivermectin (IVR) for treatment for corona virus infected patients (COVID-19): a randomized controlled trial 

Public title:

In vivo use of ivermectin (IVR) for treatment for corona virus infected patients (COVID-19): a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

In vivo use of ivermectin (IVR) for treatment for corona virus infected patients: a randomized controlled trial 

Scientific title:

In vivo use of ivermectin (IVR) for treatment for corona virus infected patients: a randomized controlled trial 

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:

Mirna Fawaz 

研究负责人:

Dr. Houssam RaaD 

Applicant:

Mirna Fawaz 

Study leader:

Dr. Houssam RaaD 

申请注册联系人电话:

Applicant telephone:

+96 1 03785199 

研究负责人电话:

Study leader's telephone:

+96 1 71026104 

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:

mirna.fawaz@bau.edu.lb 

研究负责人电子邮件:

Study leader's E-mail:

raadhoussam@yahoo.fr 

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:

Tareek Al Jadeeda, Beirut, Lebanon 

研究负责人通讯地址:

Tareek Al Jadeeda, Beirut, Lebanon 

Applicant address:

Tareek Al Jadeeda, Beirut, Lebanon 

Study leader's address:

Bordeaux2 

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:

黎巴嫩贝鲁特阿拉伯大学 

Applicant's institution:

Beirut Arab University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

ECO-R-25 

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:

Rayak University Hospital IRB 

Name of the ethic committee:

Rayak University Hospital IRB 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-04 

伦理委员会联系人:

Dr. Ali Samaha 

Contact Name of the ethic committee:

Dr. Ali Samaha 

伦理委员会联系地址:

Riyaq, Bekaa, Lebanon 

Contact Address of the ethic committee:

Riyaq, Bekaa, Lebanon 

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:

Rayak Hospital 

Primary sponsor:

Rayak Hospital 

研究实施负责(组长)单位地址:

Riyaq, Lebanon 

Primary sponsor's address:

Riyaq, Lebanon 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

黎巴嫩

省(直辖市):

贝卡

市(区县):

Riyaq

Country:

Lebanon

Province:

Beqaa

City:

Riyaq

单位(医院):

Rayak Hospital

具体地址:

Riyaq, Bekaa

Institution
hospital:

Rayak Hospital

Address:

Riyaq, Bekaa

经费或物资来源:

黎巴嫩大学 

Source(s) of funding:

Lebanese University 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

The objectives of the study are to test if: - Ivermectin is an effective treatment for COVID-19 infected patients; - Ivermectin will reduce significantly viral load within 72 hours of its administration to COVID-19 infected patients. 

Objectives of Study:

The objectives of the study are to test if: - Ivermectin is an effective treatment for COVID-19 infected patients; - Ivermectin will reduce significantly viral load within 72 hours of its administration to COVID-19 infected patients.  

药物成份或治疗方案详述:

I. First of all a pilot case control study will be conducted on asymptomatic adults positive for COVID-19. a) The subjects will be contacted based on a list provided by different laboratories performing the PCR, the aim of study and its potential outcomes will be explained b) The participants will be divided into two groups (cases and control) with respect to matching criteria (age, gender, past medical history, BMI .) and the viral load of each one will be documented. c) A baseline laboratory testing for ALT,AST and creatinine will be done and documented d) The cases will receive Ivermectin as per the below doses and the control will receive placebo (powder based tablets). 9 mg PO once if 45kg 64kg 12mg PO once if 65kg 84kg 150mcg/kg if body weight ≥ 85 Kg e) 72-hours after the intervention the participant will undergo PCR to precise their viral loads and the laboratory tests done as baseline will be repeated. f) The patient will be provided with hotline number to inform the team about any adverse reaction or any symptom during the intervention period. II. If promising results will be favor the use of Ivermectin, its application to moderate and severe case will be discussed with treating physicians as per protocol already prepared by the research team.  

Description for medicine or protocol of treatment in detail:

I. First of all a pilot case control study will be conducted on asymptomatic adults positive for COVID-19. a) The subjects will be contacted based on a list provided by different laboratories performing the PCR, the aim of study and its potential outcomes will be explained b) The participants will be divided into two groups (cases and control) with respect to matching criteria (age, gender, past medical history, BMI .) and the viral load of each one will be documented. c) A baseline laboratory testing for ALT,AST and creatinine will be done and documented d) The cases will receive Ivermectin as per the below doses and the control will receive placebo (powder based tablets). 9 mg PO once if 45kg 64kg 12mg PO once if 65kg 84kg 150mcg/kg if body weight ≥ 85 Kg e) 72-hours after the intervention the participant will undergo PCR to precise their viral loads and the laboratory tests done as baseline will be repeated. f) The patient will be provided with hotline number to inform the team about any adverse reaction or any symptom during the intervention period. II. If promising results will be favor the use of Ivermectin, its application to moderate and severe case will be discussed with treating physicians as per protocol already prepared by the research team.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. Adults with positive PCR for COVID-19 (asymptomatic for the Pilot intervention); 2. Body weight more than 45kg; 3. Consent for voluntary participation. 

Inclusion criteria

1. Adults with positive PCR for COVID-19 (asymptomatic for the Pilot intervention); 2. Body weight more than 45kg; 3. Consent for voluntary participation. 

排除标准:

1. Patients with end stage heart failure; 2. Recent cardiac intervention (less than 2 months): coronary angioplasty, ICD, CABG, Valvuloplasty or replacement; 3. Pulmonary fibrosis or advanced COPD; 4. End stage kidney or liver disease; 5. Pregnant or lactating ladies; 6. Patients on immunosuppressive therapy; 7. Active tuberculosis; 8. Active hepatitis; 9. Patients requiring planned blood transfusion (Thalasemia major, aplastic anemia). 

Exclusion criteria:

1. Patients with end stage heart failure; 2. Recent cardiac intervention (less than 2 months): coronary angioplasty, ICD, CABG, Valvuloplasty or replacement; 3. Pulmonary fibrosis or advanced COPD; 4. End stage kidney or liver disease; 5. Pregnant or lactating ladies; 6. Patients on immunosuppressive therapy; 7. Active tuberculosis; 8. Active hepatitis; 9. Patients requiring planned blood transfusion (Thalasemia major, aplastic anemia). 

研究实施时间:

Study execute time:

From2020-06-10To 2020-07-31 

征募观察对象时间:

Recruiting time:

From2020-06-10To 2020-07-20 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

Placebo

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

伊维菌素

干预措施代码:

Intervention:

USE OF IVERMECTIN (IVR)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

黎巴嫩 

省(直辖市):

贝卡 

市(区县):

 

Country:

Lebanon 

Province:

Beqaa 

City:

 

单位(医院):

All hospitals dealing with COVID-19 

单位级别:

Class B 

Institution
hospital:

All hospitals dealing with COVID-19  

Level of the institution:

Class B 

国家:

伊拉克 

省(直辖市):

巴格达 

市(区县):

 

Country:

Iraq 

Province:

Baghdad 

City:

 

单位(医院):

All hospitals dealing with COVID-19 

单位级别:

Class B 

Institution
hospital:

All hospitals dealing with COVID-19  

Level of the institution:

Class B 

测量指标:

Outcomes:

指标中文名:

Reduction of viral load and treating COVID-19 infection

指标类型:

主要指标 

Outcome:

Reduction of viral load and treating COVID-19 infection

Type:

Primary 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:

Blood

组织:

Sample Name:

Blood

Tissue:

Nose

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

Randomization will be carried out through Microsoft Excel where a random number sequence will be generated and the participants will be shuffled.

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

Randomization will be carried out through Microsoft Excel where a random number sequence will be generated and the participants will be shuffled.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

否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):

Raw data regarding individual participant data will be provided and available after being unidentified

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

Raw data regarding individual participant data will be provided and available after being unidentified

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:

- A list of potential participants and their phone numbers will be requested from the laboratories conducting PCR testing for COCID-19. - Treating physicians at participating hospital will contact the subjects as per provided list to explain the aim and the protocol of the study and to answer any potential question or concern. - Once we reach the requested number for the pilot study (30 participants) recruitment will be stopped awaiting the preliminary results. Once collected data will be entered and analyzed in SPSS.

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

- A list of potential participants and their phone numbers will be requested from the laboratories conducting PCR testing for COCID-19. - Treating physicians at participating hospital will contact the subjects as per provided list to explain the aim and the protocol of the study and to answer any potential question or concern. - Once we reach the requested number for the pilot study (30 participants) recruitment will be stopped awaiting the preliminary results. Once collected data will be entered and analyzed in SPSS.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-07
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