NCT04346043

Brief Summary

This is an exploratory study that will be performed on confirmed positive COVID-19 samples to identify the dominant viral genome strain in Egyptians using next generation sequencing (NGS).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 13, 2020

Last Update Submit

April 17, 2020

Conditions

Keywords

Egypt

Outcome Measures

Primary Outcomes (1)

  • Dominant viral genome strain

    Identify the dominant viral genome strain in Egyptians With COVID-19 infection using next generation sequencing (NGS)

    9 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 cases of COVID-19 samples proved to be positive in Ain Shams University Specialized Hospital labs (at the Universities reference lab) will be tested in the strain study.

You may qualify if:

  • Patients With confirmed COVID-19

You may not qualify if:

  • inadequate sample of the patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11556, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal \& oropharyngeal swabs will be taken from patients with COVID-19

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Fatma Soliman E Ebeid

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Faculty of Medicine Ain Shams University Research Institute

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

April 20, 2020

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations