Post COVID-19 Functional Status in Egypt

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04479293
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 80.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Coronavirus Disease; SARS-CoV-2	Other: Post COVID-19 Functional Satus Scale

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Oct 30, 2020
• Anticipated Study Completion Date: Nov 30, 2020

Outcome Measures

Primary Outcome Measures

1. number of functional limitations post COVID-19 [3-6 month]

   scale 0-64 points

Secondary Outcome Measures

1. number of psychologic changes [3-6 months]

   Hamilton scale, points

2. Sleep Disturbance and quality [3-6 months]

   ESS scale 0-20, points

3. Radiologic changes [3-6 months]

   Chest HRCT

4. Laboratory changes [3-6 moths]

   Complete blood count, C - reactive protein, serum ferritin

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All confirmed cases with COVID-19

Exclusion Criteria:

• Non COVID-19 cases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aliaa Hussein	Assiut		Egypt	71515

Sponsors and Collaborators

• Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aliae AR Mohamed Hussein, Professor of Pulmonology, Assiut University
• ClinicalTrials.gov Identifier: NCT04479293
• Other Study ID Numbers: AssiutU16
• First Posted: Jul 21, 2020
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aliae AR Mohamed Hussein, Professor of Pulmonology, Assiut University: Functional score; Radiologic changes; Psychologic changes; Laboratory; Sleep disturbance
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 9, 2020