Clinical trial NCT04443712: Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)
Official title: Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease 2019 (COVID19)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 1900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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:

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.

Eligibility criteria: Inclusion Criteria - All hospitalized patients in Ain-Shams University Hospitals.

Exclusion Criteria:

- Those who refuse to participate in the trial

Primary outcomes:
measure: The incidence of the new COVID19 among hospitalized patients
timeFrame: 12 months
Secondary outcomes:
measure: Cost of screening hospitalized patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Vice Director of ASU Hospital
name: Samia Girgis
role: PRINCIPAL_INVESTIGATOR
References: