COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience

Study Overview
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Brief Summary
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The present study conducted to correlate symptoms not only constitutional and respiratory, but GIT as a principle presentation, with laboratory markers and COVID-19 severe acute respiratory syndrome (SARS-COV2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict COVID-19 outcomes based on real-time experience.

Detailed Description
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This observational retrospective cohort single center national study was conducted on patients who tested positive COVID-19 infection by the polymerase chain reaction (PCR) of nasopharyngeal sample in the period from first June to the med of July 2020. Patients were recruited from Kasr Al-Aini School of medicine, COVID-19 out-patient clinic, Cairo University hospitals. The diagnosis and classification of severity of COVID-19 infection were made according to the clinical management of COVID-19, released by the World Health Organization (WHO), mild and moderate case were recruited, the treatment protocol used was according to the Egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, Mild and moderate cases once diagnosed by PCR received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. Steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms. Any adult patient (age ≥18 years) suffering from mild or moderate COVID-19 infection was included in this study. While severe cases according to WHO classifications and patients aged less than18 were excluded from the study.

Official Title
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Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center Experience

Conditions
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Covid19, Diarrhea

Intervention / Treatment
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* Drug: Hydroxychloroquine Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild and moderate COVID-19 patients: Exclusion Criteria: Age less than 18 years Severe COVID-19 patients: with dyspnea, hypoxia, or >50 percent lung involvement on imaging within 24 to 48 hours Critical COVID-19 patients: with respiratory failure, shock, or multiorgan dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Duration of COVID-19 symptoms less than 12 days | Drug: Hydroxychloroquine Pill<br>* hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started<br>* Other names: zinc pill;|
| Group 2<br>Duration of COVID-19 symptoms equal or more than 12 days | Drug: Hydroxychloroquine Pill<br>* hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started<br>* Other names: zinc pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 disease spectrum and duration | The investigators tried to correlate disease severity with disease duration | july 2020 to june 2020 | 
| GIT manifestations among COVID-19 patients | spectrum of GIT manifestations in COVID-19 patients was investigated | july 2020 to june 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-communicable disease and COVID-19 | The link between non-communicable disease (including diabetes, hypertension and Hypercholesterolemia) severity and COVID-19 prognosis | july 2020 to june 2020 | 
| Seasonal change and COVID-19 | the investigators studied the Impact of weather climate on COVID-19 presentations (higher incidence of diarrhea in COVID-19 patients in summer) and outcomes | july 2020 to june 2020 | 
| Possible region specific classification for COVID-19 disease | The investigators tried to find new Egyptian classification fro COVID-19 disease severity | july 2020 to june 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 disease outcomes and duration, GIT manifestations, Diarrhea