ChiCTR2100042375 版本V1.1 版本创建时间2021/04/23 00:23:59 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100042375 

最近更新日期：

Date of Last Refreshed on：

 2021-04-23 00:23:10 

注册时间：

Date of Registration：

 2021-01-21 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Evaluation of Biomarkers for Prediction of Morbidity and Mortality in COVID-19 at a Tertiary Care Center in Pakistan

Public title：

Evaluation of Biomarkers for Prediction of Morbidity and Mortality in COVID-19 at a Tertiary Care Center in Pakistan

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Evaluation of Biomarkers for Prediction of Morbidity and Mortality in COVID-19 at a Tertiary Care Center in Pakistan

Scientific title：

Evaluation of Biomarkers for Prediction of Morbidity and Mortality in COVID-19 at a Tertiary Care Center in Pakistan

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：

Dr Sibtain Ahmed 

研究负责人：

Dr Sibtain Ahmed 

Applicant：

Dr Sibtain Ahmed 

Study leader：

Dr Sibtain Ahmed 

申请注册联系人电话：

Applicant telephone：

 +922134861951

研究负责人电话：

Study leader's
telephone：

+922134861951

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：

 sibtain.ahmed@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 sibtain.ahmed@gmail.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：

Sopari wala bldg, AKU, Karachi, PK

研究负责人通讯地址：

Sopari wala bldg, AKU, Karachi, PK

Applicant address：

Sopari wala bldg, AKU, Karachi, PK

Study leader's address：

Sopari wala bldg, AKU, Karachi, PK

申请注册联系人邮政编码：

Applicant postcode：

 74800

研究负责人邮政编码：

Study leader's postcode：

 74800

申请人所在单位：

巴基斯坦卡拉奇Aga Khan University

Applicant's institution：

Aga Khan University

研究负责人所在单位：

巴基斯坦卡拉奇Aga Khan University

Affiliation of the Leader：

Aga Khan 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：

 2020-5168-14099

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：

Aga Khan University Ethical Review Committee

Name of the ethic committee：

Aga Khan University Ethical Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-09-10 00:00:00

伦理委员会联系人：

Aga Khan University Ethical Review Committee

Contact Name of the ethic committee：

Aga Khan University Ethical Review Committee

伦理委员会联系地址：

Sopari wala bldg, AKU, Karachi, PK

Contact Address of the ethic committee：

Sopari wala bldg, AKU, Karachi, PK

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：

No

Primary sponsor：

None

研究实施负责（组长）单位地址：

No

Primary sponsor's address：

None

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No

Source(s) of funding：

None

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：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

To evaluate the association of Serum Procalcitonin and other biochemical markers including ferritin, CRP, IL-6 with severity in Coronavirus disease 2019 (COVID-19), hospitalized patients and to test the hypothesis that they are an independent predictor of mortality.  

Objectives of Study：

To evaluate the association of Serum Procalcitonin and other biochemical markers including ferritin, CRP, IL-6 with severity in Coronavirus disease 2019 (COVID-19), hospitalized patients and to test the hypothesis that they are an independent predictor of mortality.

药物成份或治疗方案详述：

This study was conducted at Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University (AKU), Karachi. Medical records of all in-patients including both genders, and all age groups with documented COVID-19 from 1st March to 10th August 2020 were reviewed. The subjects were divided into two categories severe and non-severe COVID-19; and survivors and non-survivors. The details were recorded on a pre-structured performa. Between-group differences were tested using the Mann–Whitney's U-test. The receiver operating characteristic curve was plotted for ferritin with severity and mortality. A binary logistic regression was used to identify variables independently associated with mortality. The data was analyzed using SPSS. 

Description for medicine or protocol of treatment in detail：

This study was conducted at Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University (AKU), Karachi. Medical records of all in-patients including both genders, and all age groups with documented COVID-19 from 1st March to 10th August 2020 were reviewed. The subjects were divided into two categories severe and non-severe COVID-19; and survivors and non-survivors. The details were recorded on a pre-structured performa. Between-group differences were tested using the Mann–Whitney's U-test. The receiver operating characteristic curve was plotted for ferritin with severity and mortality. A binary logistic regression was used to identify variables independently associated with mortality. The data was analyzed using SPSS. 

纳入标准：

both genders and aged 18 years and older groups with SARS-CoV-2 positive on a reverse-transcriptase polymerase chain reaction (PCR) test and received treatment at our center

Inclusion criteria

both genders and aged >=18 years old groups with SARS-CoV-2 positive on a reverse-transcriptase polymerase chain reaction (PCR) test and received treatment at our center.

排除标准：

1) biochemical work up on admission not undertaken;
2) known thalassemic cases.

Exclusion criteria：

1) biochemical work up on admission not undertaken;
2) known thalassemic cases.

研究实施时间：

Study execute time：

从 From 2020-03-01 00:00:00至 To 2020-08-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-03-01 00:00:00 至 To 2020-08-10 00:00:00

干预措施：

Interventions：

组别：

Severe COVID

样本量：

 86

Group：

Severe COVID

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

组别：

non-severe COVID

样本量：

 71

Group：

non-severe COVID

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 信德 

市(区县)：

  

Country：

Pakistan

Province：

Sindh

City：

单位(医院)：

 AKU 

单位级别：

 三级 

Institution
hospital：

AKU

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

预后

指标类型：

主要指标

Outcome：

Prognosis

Type：

Primary indicator

测量时间点：

测量方法：

procalcitonin and ferritin

Measure time point of outcome：

Measure method：

procalcitonin and ferritin

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

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：

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 100 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）：

Owing to the retrospective data analysis, biochemical marker levels were obtained within 48 hours of admission for all in patients as routine care protocol of COVID-19.

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

Owing to the retrospective data analysis, biochemical marker levels were obtained within 48 hours of admission for all in patients as routine care protocol of COVID-19.

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：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

是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）：

article publication

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

article publication

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：

electronic data from health records

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

electronic data from health records

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-01-21 06:28:04