Characteristics and Outcomes of Gastrointestinal Manifest... | NCT04490772

Studies
Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

NCT04490772

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 29, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Infectious

Interventions

Laboratory tests

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2020Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jul 20, 2020

First Submission Date that Met QC Criteria

Jul 27, 2020

First Posted Date

Jul 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2020

Last Update Posted Date

Jul 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haidi Karam, Lecturer of Tropical Medicine and Gastroenterology, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Covid-19		COVID-19 patients presented with gastrointestinal manifestations	Diagnostic Test: Laboratory tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laboratory tests	Diagnostic Test	Laboratory tests such as CBC, Liver function and CRP	Patients with Covid-19

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed Covid-19 with GIT manifestations

Exclusion Criteria:

Patients refuse to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Confirmed Covid-19 with GIT manifestations

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003141	Communicable Diseases
D000086382	COVID-19

Ancestor Terms

ID	Term
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019411	Clinical Laboratory Techniques

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided