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Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04490772
Recruitment Status : Not yet recruiting
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Haidi Karam, Assiut University

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

Condition or disease Intervention/treatment
Infectious 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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




Primary Outcome Measures :
  1. Clinical data questionnaire [ Time Frame: 2 months ]
    Clinical characteristics of age, sex, comorbidities and symptoms.

  2. Tests such as CBC [ Time Frame: 2 months ]
    Laboratory characters

  3. liver function test [ Time Frame: 2 months ]
    Laboratory characters



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Confirmed Covid-19 with GIT manifestations
Criteria

Inclusion Criteria:

  • Confirmed Covid-19 with GIT manifestations

Exclusion Criteria:

  • Patients refuse to participate
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Responsible Party: Haidi Karam, Lecturer of Tropical Medicine and Gastroenterology, Assiut University
ClinicalTrials.gov Identifier: NCT04490772    
Other Study ID Numbers: COVID gastro intestinal
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haidi Karam, Assiut University:
Covid-19
characteristics
Outcome
Egypt
Additional relevant MeSH terms:
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Communicable Diseases
Infection