Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)

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

Study Overview

• Status: Unknown
• Conditions: Coronavirus Disease 2019 (COVID19)

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.

• Study Type: Observational
• Enrollment (Anticipated): 1900

Contacts and Locations

• Study Contact: Name: Samia Girgis; Phone Number: +20 122 336 6500; Email: drsamia.girgis@med.asu.edu.eg

Study Locations

• Egypt
  • Non-US
    • Cairo, Non-US, Egypt, 11566
      • Recruiting
      • Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Exclusion Criteria:

- Those who refuse to participate in the trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of screening hospitalized patients	To determine the cost of screening hospitalized patients	12 months

Collaborators and Investigators

• Sponsor: Samia Girgis
• Investigators: Principal Investigator: Samia Girgis, Vice Director of ASU Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 20, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FMASU P29 /2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No