Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04443712 |
| Other study ID # |
FMASU P29 /2020 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2020 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
June 2020 |
| Source |
Ain Shams University |
| Contact |
Samia Girgis |
| Phone |
+20 122 336 6500 |
| Email |
drsamia.girgis[@]med.asu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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:
1. 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)
2. Reverse Transcription Polymerase Chain Reaction (RT-PCR)
3. 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.
