- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04443712
Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Non-US
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Cairo, Non-US, Egypt, 11566
- Rekruttering
- Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria - All hospitalized patients in Ain-Shams University Hospitals.
Exclusion Criteria:
- Those who refuse to participate in the trial
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The incidence of the new COVID19 among hospitalized patients
Tidsramme: 12 months
|
To measure the incidence of the new SARS-COV-2 (COVID19) among patients seeking hospitalization to Ain-Shams University Hospitals
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12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cost of screening hospitalized patients
Tidsramme: 12 months
|
To determine the cost of screening hospitalized patients
|
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Samia Girgis, Vice Director of ASU Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FMASU P29 /2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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