NCT04479293

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

July 19, 2020

Last Update Submit

September 7, 2020

Conditions

COVID-19Coronavirus DiseaseSARS-CoV-2

Keywords

Functional scoreRadiologic changesPsychologic changesLaboratorySleep disturbance

Outcome Measures

Primary Outcomes (1)

  • number of functional limitations post COVID-19

    scale 0-64 points

    3-6 month

Secondary Outcomes (4)

  • number of psychologic changes

    3-6 months

  • Sleep Disturbance and quality

    3-6 months

  • Radiologic changes

    3-6 months

  • Laboratory changes

    3-6 moths

Interventions

Post COVID-19 Functional Satus ScaleOTHER

scale from 0-64 assessing functional limitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All confirmed cases with COVID-19

You may not qualify if:

  • Non COVID-19 cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aliaa Hussein

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19Parasomnias

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Aliae Mohamed-Hussein, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliae Mohamed-Hussein

CONTACT

01222302352aliaehussein@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pulmonology

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 21, 2020

Study Start

July 1, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

EG(1)