Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

Patients confirmed COVID-19 with gastrointestinal manifestations will be included. Characteristics and outcomes will be described for them.

Study Overview

• Status: Unknown
• Conditions: Infectious
• Intervention / Treatment: Diagnostic test: Laboratory tests

Detailed Description

Patients diagnosed as confirmed Covid-19 according to WHO and Egyptian Ministry of Health and Population (MOH) definitions will be included.The following will be done for all patients:

Demographic characters; age, sex, presence of co-morbidities such as hypretension, diabetes mellitus, obstructive lung diseases, ischemic heart diseases...etc, history of contact to covid-19 patients or recent travelling abroad.Clinical Characteristics: By recording of clinical manifestation such as fever, cough, shortness of breath, sore throat, change in taste or smell, nausea,vomiting and diarrhea will be done. Complications and the type of treatment received by the patients will also be described including mechanical ventilation.

Laboratory data will also be included : blood picture, liver enzymes, ESR,CRP, serum ferritin, D-dimer and troponin.

Follow up of the patients will be done until improvement, deaths or complications to determine disease outcomes.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Confirmed Covid-19 with GIT manifestations

Description

Inclusion Criteria:

• Confirmed Covid-19 with GIT manifestations

Exclusion Criteria:

• Patients refuse to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Covid-19; COVID-19 patients presented with gastrointestinal manifestations	Diagnostic test: Laboratory tests; Laboratory tests such as CBC, Liver function and CRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical data questionnaire	Clinical characteristics of age, sex, comorbidities and symptoms.	2 months
Tests such as CBC	Laboratory characters	2 months
liver function test	Laboratory characters	2 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; Outcome; Egypt; characteristics
• 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: COVID gastro intestinal

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