Coronavirus Disease 2019 (COVID19)NCT04443712
Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)
An observational study of Coronavirus Disease 2019 (COVID19), run by Samia Girgis at 1 site in Egypt.
Trial summary
The objective of this study is to screen the patients seeking hospitalization in Ain Shams university hospitals and identify a cost effective tool for continuing screening the patients all through the epidemic period Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Disease 2019 (COVID19)
- How many people
- 1,900 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2020to 1 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients needing admission in Ain-Shams University Hospitals; which is a campus including the following main hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine, surgical, cardiothoracic and Geriatrics.
Who may be able to join
None listed.
Who cannot join
- Those who refuse to participate in the trial
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
Fatma Soliman E Ebeid, 01095569596, dr.fatma_ebeid@yahoo.com
About this study
The objective of this study is to screen the patients seeking hospitalization in Ain Shams university hospitals and identify a cost effective tool for continuing screening the patients all through the epidemic period
Read the detailed description
Study setting: Ain-Shams University Hospitals. It is a campus including the following main hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine, surgical, cardiothoracic and Geriatrics.
Study population: All patients needing admission in Ain-Shams University Hospitals are eligible for the study.
Sample size: There is no incidence data published till now. Only the confirmed detected cases have been reported. We assumed that the community cases are around 10 times that of detected cases.
it was estimated to be 1900 patients with 95% confidence level given the frequency of positive screening 0.05% with precision ± 0.1%. 10
The patients will be enrolled in the study using consecutive sample till the sample size is achieved.
Study methods:
Every enrolled patient will be subjected to:
- An interview questionnaire including personal data ( age, gender, residence , contact details ) , epidemiological data (history of contact to a COVID-19 case, History of travel), clinical data history ( Fever, Cough, sore throat)
- Reverse Transcription Polymerase Chain Reaction (RT-PCR)
- Antibody IgM-IgG test for SARS-CoV-2
Statistical analysis:
Data will be validated, cleaned and entered in spreadsheet. SPSS program will be used for analysis.
Qualitative data will be presented in frequency and related percentage. Quantitative data with normal distribution will be presented in mean and standard deviation or median and interquartile for non-normally distributed data.
Incidence of positive screening test among the total will be calculated with 95% confidence interval.
Comparison between groups will be done using relevant suitable parametric or non-parametric tests. A "P" value of 0.05 is decided to be the level of significance.
Risk ratios will be calculated for estimation of risk with 95% confidence interval.
Cost per one positive detected screening test will be calculated (Total cost / total positive cases). The direct and indirect costs will be calculated by the laboratory department.
Ethical considerations:
The protocol will be submitted for approval by the University Ethical Research Committee.
The objectives and methods of the research will be explained to the participants.
An informed consent will be obtained from subjects willing to participate in the research and the subjects are free to withdraw from research anytime.
Confidentiality of the data will be highly secured. Positive cases will be reported to the Ministry of Health and Population (MOHP). The guidelines of isolation and treatment protocol of MOHP will be followed.
- Conditions
- Coronavirus Disease 2019 (COVID19)
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the new COVID19 among hospitalized patients
To measure the incidence of the new SARS-COV-2 (COVID19) among patients seeking hospitalization to Ain-Shams University Hospitals
Measured: 12 months
Secondary outcomes (1)
Cost of screening hospitalized patients
To determine the cost of screening hospitalized patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start29 May 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (COVID19)Studies 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
- Cross-sectional
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samia Girgis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samia Girgis, Ain Shams University
- Investigators
- Samia Girgis, Principal investigator, Vice Director of ASU Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443712
- Sponsor's protocol ID
- FMASU P29 /2020
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)
- ClinicalTrials.gov ID
- NCT04443712
- Acronym / sponsor ID
- FMASU P29 /2020
- Conditions
- Coronavirus Disease 2019 (COVID19)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Samia GirgisUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 23 Jun 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.
The objective of this study is to screen the patients seeking hospitalization in Ain Shams university hospitals and identify a cost effective tool for continuing screening the patients all through the epidemic period
Detailed description
Study setting: Ain-Shams University Hospitals. It is a campus including the following main hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine, surgical, cardiothoracic and Geriatrics.
Study population: All patients needing admission in Ain-Shams University Hospitals are eligible for the study.
Sample size: There is no incidence data published till now. Only the confirmed detected cases have been reported. We assumed that the community cases are around 10 times that of detected cases.
it was estimated to be 1900 patients with 95% confidence level given the frequency of positive screening 0.05% with precision ± 0.1%. 10
The patients will be enrolled in the study using consecutive sample till the sample size is achieved.
Study methods:
Every enrolled patient will be subjected to:
- An interview questionnaire including personal data ( age, gender, residence , contact details ) , epidemiological data (history of contact to a COVID-19 case, History of travel), clinical data history ( Fever, Cough, sore throat)
- Reverse Transcription Polymerase Chain Reaction (RT-PCR)
- Antibody IgM-IgG test for SARS-CoV-2
Statistical analysis:
Data will be validated, cleaned and entered in spreadsheet. SPSS program will be used for analysis.
Qualitative data will be presented in frequency and related percentage. Quantitative data with normal distribution will be presented in mean and standard deviation or median and interquartile for non-normally distributed data.
Incidence of positive screening test among the total will be calculated with 95% confidence interval.
Comparison between groups will be done using relevant suitable parametric or non-parametric tests. A "P" value of 0.05 is decided to be the level of significance.
Risk ratios will be calculated for estimation of risk with 95% confidence interval.
Cost per one positive detected screening test will be calculated (Total cost / total positive cases). The direct and indirect costs will be calculated by the laboratory department.
Ethical considerations:
The protocol will be submitted for approval by the University Ethical Research Committee.
The objectives and methods of the research will be explained to the participants.
An informed consent will be obtained from subjects willing to participate in the research and the subjects are free to withdraw from research anytime.
Confidentiality of the data will be highly secured. Positive cases will be reported to the Ministry of Health and Population (MOHP). The guidelines of isolation and treatment protocol of MOHP will be followed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients needing admission in Ain-Shams University Hospitals; which is a campus including the following main hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine, surgical, cardiothoracic and Geriatrics.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Those who refuse to participate in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of the new COVID19 among hospitalized patients
Time frame: 12 months
To measure the incidence of the new SARS-COV-2 (COVID19) among patients seeking hospitalization to Ain-Shams University Hospitals
1 secondary outcome
Cost of screening hospitalized patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Samia Girgis principal investigator
Vice Director of ASU Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019 (COVID19), run by Samia Girgis at 1 site in Egypt.
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 0 inclusion and 1 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 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Samia Girgis (+20 122 336 6500, drsamia.girgis@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of the new COVID19 among hospitalized patients (time frame: 12 months). 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 23 Jun 2020.