Post COVID-19 Functional Status in Egypt

September 7, 2020 updated by: Aliae AR Mohamed Hussein, Assiut University

Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score

Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients diagnosed as COVID-19 on clinical, laboratory, radiologic or PCR based are included.

Patients with different severity mild, moderate, severe , managed at home or in hospitals are included.

Description

Inclusion Criteria:

  • All confirmed cases with COVID-19

Exclusion Criteria:

  • Non COVID-19 cases

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of functional limitations post COVID-19
Time Frame: 3-6 month
scale 0-64 points
3-6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of psychologic changes
Time Frame: 3-6 months
Hamilton scale, points
3-6 months
Sleep Disturbance and quality
Time Frame: 3-6 months
ESS scale 0-20, points
3-6 months
Radiologic changes
Time Frame: 3-6 months
Chest HRCT
3-6 months
Laboratory changes
Time Frame: 3-6 moths
Complete blood count, C - reactive protein, serum ferritin
3-6 moths

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Aliae Mohamed-Hussein, MD, Assiut University

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 (Actual)

July 1, 2020

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

July 19, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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