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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04460547
Other study ID # COAHS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 25, 2020
Est. completion date September 20, 2020

Study information

Verified date July 2020
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19 infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The Research interest led to registration of Interventional and Observational studies world wide. There are constant efforts by Health care workers to seek information regarding the Interventional and Observational studies which can help in decision making regarding effective handling of COVID-19 infected patients. It is also important to track on the happenings in various frontiers of COVID-19 Research in view of historical interest and clinical relevance. This Observational Cross sectional study aims to explore the completed Researches in WHO-compliant registries to understand the trends of COVID-19 Research. This study aims to get a birds eye view of ongoing COVID-19 Research scenario worldwide. This study results can directly benefit the worldwide Academicians and Health Care Professionals to understand the ongoing COVID-19 Research trends.


Description:

On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19 infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The Research interest led to registration of Interventional and Observational studies world wide.

AIMs & Objectives of the Study This Observational Cross sectional study aims to explore the completed Researches in WHO-compliant registries to understand the trends of COVID-19 Research.

This study results can directly benefit the worldwide Academicians and Health Care Professionals to understand the ongoing COVID-19 Research trends.

Primary Outcomes of the Study To understand the geographical distribution of the interventional studies after 11th of March 2020.

To understand the geographical distribution of the Observational studies after 11th of March 2020.

To understand the monthly Research study completion rate as per geographic distribution of the Research.

Secondary Outcomes of the Study To understand the statistical correlation of the interventional studies Research with developed, developing and under developed countries.

To understand the statistical correlation of the observational studies Research with developed, developing and under developed countries.

To understand the statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.

To understand the statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.

To understand the statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.

Methodology WHO-compliant registries will be explored for completed COVID-19 Research articles.

Inclusion Criteria Interventional studies in the WHO-compliant registries database which are registered and completed after 11th of March 2020 until 15th of August 2020.

Observational studies in the WHO-compliant registries database which are registered and completed after 11th of March 2020 until 15th of August 2020.

Exclusion Criteria Interventional studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.

Observational studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.

The articles selected from the WHO-compliant registries database will be categorized as per following relevance:

Interventional Studies: Theses studies will be further categorized based on type of Intervention. Inteventional studies can be Drug, Diagnostic tests, Rehabilitation, Procedure, Device, Behavioral, Dietary supplement, Biological, Physiotherapy & Others types of Interventional study.

Observational Studies: Prospective and Retrospective Observational studies.

The Studies will be mapped according to the Country where the Research is completed and the type of Research.

Type of Variables studied in this Study 6 Continuous variables are studied in this Study Number of Interventional Studies (Continuous variable) Number of Observational Studies (Continuous variable) Number of Drug based Interventional Study (Continuous variable) Number of Diagnostic test based interventional study (Continuous variable) Number of Device based interventional study (Continuous variable) Monthly Research study completion rate (Continuous variable)

8 Categorical variables will be studies in this study Interventional Study (Categorical variable) Observational Study (Categorical variable) Developed country (Categorical variable) Developing country (Categorical variable) Under developed country (Categorical variable) Drug based Interventional Study (Categorical variable) Diagnostic test based interventional study (Categorical variable) Device based interventional study (Categorical variable)

Statistical Analysis Data analysis will be carried out using SPSS 22.00 (Stata Corp, College Station, TX, USA). The Data obtained will be analysed for the normal distribution. If the data follows normal distribution curve, Pearson Correlation statistical test will be used to assess the Correlation of categorical and continuous variables. If the data does not follow normal distribution curve, Spearman Correlation or Chi square statistical test will be used to assess the Correlation of Categorical and continuous variables. The p-value (significance level) of the correlation will be determined. If the p-value is <5%, then the correlation between variables analysed will be considered as significant.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 20, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria:

Interventional studies in the WHO-compliant registries database which are registered and completed after 11th of March 2020 until 15th of August 2020.

Observational studies in the WHO-compliant registries database which are registered and completed after 11th of March 2020 until 15th of August 2020.

Exclusion Criteria:

Interventional studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.

Observational studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Convalescent Plasma Transfusion
Convalescent Plasma Transfusion to COVID-19 infected patients.
Hydroxychloroquine
Hydroxychloroquine administration to COVID-19 infected patients.
DAS181
DAS181 administration to COVID-19 infected patients.
Ivermectin
Ivermectin administration to COVID-19 infected patients.
Interferon Beta-1A
Interferon Beta-1A administration to COVID-19 infected patients.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qassim University

Outcome

Type Measure Description Time frame Safety issue
Primary Geographical distribution of the interventional studies after 11th of March 2020. To understand the geographical distribution of the interventional studies after 11th of March 2020. 15th of August 2020
Primary Geographical distribution of the Observational studies after 11th of March 2020. To understand the geographical distribution of the Observational studies after 11th of March 2020. 15th of August 2020
Primary Monthly Research study completion rate as per geographic distribution of the Research. To understand the monthly Research study completion rate as per geographic distribution of the Research. 15th of August 2020
Secondary Statistical correlation of the interventional studies Research with developed, developing and under developed countries. To understand the statistical correlation of the interventional studies Research with developed, developing and under developed countries. 15th of August 2020
Secondary Statistical correlation of the observational studies Research with developed, developing and under developed countries. To understand the statistical correlation of the observational studies Research with developed, developing and under developed countries. 15th of August 2020
Secondary Statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries. To understand the statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries. 15th of August 2020
Secondary Statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries. To understand the statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries. 15th of August 2020
Secondary Statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries. To understand the statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries. 15th of August 2020
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