NCT04484597

Brief Summary

Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19

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 Mar 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

March 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 14, 2020

Last Update Submit

July 22, 2020

Conditions

Positive COVID-19 by PCR

Keywords

COVID 19Rt PCRCTRapid tests

Outcome Measures

Primary Outcomes (1)

  • correlation of COVID-19 antibody to PCR

    Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM \& IgG and the severity of the clinical picture

    1 year

Secondary Outcomes (1)

  • correlation of ancillaey tests to PCR

    1 year

Interventions

Rt PCRDIAGNOSTIC_TEST

positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition

Eligibility Criteria

Age4 Days+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition

You may qualify if:

  • All cases positive COVID 19 RT PCR

You may not qualify if:

  • cases with chronic diseases ( cancers, diabetes Liver or Kidney )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Refat Sadeq

Port Said, 22223, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 23, 2020

Study Start

March 15, 2020

Primary Completion

August 15, 2020

Study Completion

September 15, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)