COVID-19NCT04460547
Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic
An observational study of COVID-19, run by Qassim University.
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Convalescent Plasma Transfusion, Hydroxychloroquine and DAS181
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2020to 20 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Child, Adult, Older adult
Study population: Subjects who are infected with COVID-19. Healthy Volunteers who respond to survey. Subjects who have recently recovered from COVID-19 infection.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic: An Observational Study
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.
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- Convalescent Plasma Transfusion, Hydroxychloroquine, DAS181, Ivermectin, Interferon Beta-1A
- Keywords
- Research trends, COVID-19, Pandemic, Interventional studies, Observational studies
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent Plasma TransfusionDrug
Convalescent Plasma Transfusion to COVID-19 infected patients.
Hydroxychloroquine administration to COVID-19 infected patients.
DAS181Drug
DAS181 administration to COVID-19 infected patients.
IvermectinDrug
Ivermectin administration to COVID-19 infected patients.
Interferon Beta-1ADrug
Interferon Beta-1A administration to COVID-19 infected patients.
| Study group | Role | What they receive |
|---|---|---|
| Completed Interventional studies | Interventional studies in the WHO-compliant registries database which are registered and completed before 11th March 2020. Receives: Drug: Convalescent Plasma Transfusion; Drug: Hydroxychloroquine; Drug: DAS181; Drug: Ivermectin; Drug: Interferon Beta-1A | |
| Completed Observational studies | Observational studies in the WHO-compliant registries database which are registered and completed before 11th March 2020. Receives: Drug: Convalescent Plasma Transfusion; Drug: Hydroxychloroquine; Drug: DAS181; Drug: Ivermectin; Drug: Interferon Beta-1A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15th of August 2020
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.
Measured: 15th of August 2020
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.
Measured: 15th of August 2020
Secondary outcomes (5)
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.
Measured: 15th of August 2020
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.
Measured: 15th of August 2020
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.
Measured: 15th of August 2020
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.
Measured: 15th of August 2020
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.
Measured: 15th of August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start25 Jul 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion20 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shiva Shankar Bugude, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460547
- Sponsor's protocol ID
- COAHS
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Research data will be extracted from the WHO-compliant registry databases.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic: An Observational Study
- ClinicalTrials.gov ID
- NCT04460547
- Acronym / sponsor ID
- COAHS
- Conditions
- COVID-19
- Keywords
- Research trends, COVID-19, Pandemic, Interventional studies, Observational studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Completed Interventional studies | – | Drug: Convalescent Plasma Transfusion, Drug: Hydroxychloroquine, Drug: DAS181, Drug: Ivermectin, Drug: Interferon Beta-1AInterventional studies in the WHO-compliant registries database which are registered and completed before 11th March 2020. |
| Completed Observational studies | – | Drug: Convalescent Plasma Transfusion, Drug: Hydroxychloroquine, Drug: DAS181, Drug: Ivermectin, Drug: Interferon Beta-1AObservational studies in the WHO-compliant registries database which are registered and completed before 11th March 2020. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who are infected with COVID-19. Healthy Volunteers who respond to survey. Subjects who have recently recovered from COVID-19 infection.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convalescent Plasma TransfusionConvalescent Plasma Transfusion to COVID-19 infected patients. | Drug | Completed Interventional studies, Completed Observational studies |
| HydroxychloroquineHydroxychloroquine administration to COVID-19 infected patients. | Drug | Completed Interventional studies, Completed Observational studies |
| DAS181DAS181 administration to COVID-19 infected patients. | Drug | Completed Interventional studies, Completed Observational studies |
| IvermectinIvermectin administration to COVID-19 infected patients. | Drug | Completed Interventional studies, Completed Observational studies |
| Interferon Beta-1AInterferon Beta-1A administration to COVID-19 infected patients. | Drug | Completed Interventional studies, Completed Observational studies |
Primary outcome
Geographical distribution of the interventional studies after 11th of March 2020.
Time frame: 15th of August 2020
To understand the geographical distribution of the interventional studies after 11th of March 2020.
Geographical distribution of the Observational studies after 11th of March 2020.
Time frame: 15th of August 2020
To understand the geographical distribution of the Observational studies after 11th of March 2020.
Monthly Research study completion rate as per geographic distribution of the Research.
Time frame: 15th of August 2020
To understand the monthly Research study completion rate as per geographic distribution of the Research.
5 secondary outcomes
Statistical correlation of the interventional studies Research with developed, developing and under developed countries.
Time frame: 15th of August 2020
Statistical correlation of the observational studies Research with developed, developing and under developed countries.
Time frame: 15th of August 2020
Statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.
Time frame: 15th of August 2020
Statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.
Time frame: 15th of August 2020
Statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.
Time frame: 15th of August 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No. The Research data will be extracted from the WHO-compliant registry databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Qassim University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geographical distribution of the interventional studies after 11th of March 2020. (time frame: 15th of August 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.