Characteristics and Outcome of Coronavirus Disease 2019 (COVID-19) in Egypt (COVID-19)

April 7, 2020 updated by: Haidi Karam, Assiut University

Characteristics and Outcome of COVID-19 Among Egyptian Patients

The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Egypt is one of the countries that has been infected by Covid-19. The characteristics of clinical presentation, laboratory and radiological data are not yet studied. Outcomes of covid-19 in Egypt also have not been described yet.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Patients admitted to Assiut University hospital, Al Rajhi liver hospital and other covid-19 Quarantine hospitals will be included. The characteristics of patients will be described such as demographic data; age, sex,history of contact to COVID-19 patients or traveling abroad and their clinical manifestation such as fever,cough,shortness of breath, sore throat, diarrhea. Laboratory data will also be included such as blood picture,D-Dimer, serum ferritin, creatinine, liver enzymes, oxygen saturation and covid-19 polymerase chain reaction (PCR). Radiological data will be described as regarding chest X-ray and/or computed tomography.

Patients will be followed until complications, improvement, transfer to another hospital or death and their outcome will be described.

Study Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with clinical presentation and confirmed as Covid-19 according to the definition of Egyptian Ministry of Health.

Description

Inclusion Criteria:

  • Patients with diagnosis of Covid-19 .

Exclusion Criteria:

  • Patients refuse to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Covid-19
Patients with clinical presentation and confirmed as Covid-19 according to the definition of Egyptian Ministry of Health
Follow up to assess the outcome until complications, improvement, death or being transferred to another quarantine hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics of Coronavirus Disease 2019 (COVID-19) in the cohort group
Time Frame: 2 months
Sheet recording age, sex, co-morbidity,history of contact
2 months
Clinical manifestations of Coronavirus Disease 2019 (COVID-19)
Time Frame: 2 month
Sheet recording symptoms and signs
2 month
Laboratory data of included Coronavirus Disease 2019 (COVID-19) cohort
Time Frame: 2 months
blood picture,D-Dimer, creatinine, liver enzymes
2 months
Radiological features of Coronavirus Disease 2019 (COVID-19) cohort
Time Frame: 2 month
Chest x-ray and/or Computed tomography
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outcomes of Coronavirus Disease 2019 (COVID-19) infection in the cohort group
Time Frame: 1 week
Data recording of the outcomes of treatment
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2020

Primary Completion (ANTICIPATED)

July 30, 2020

Study Completion (ANTICIPATED)

July 30, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data prescribed in the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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