NCT04409574

Brief Summary

This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers, assessment of clinical presentation and severity of COVID 19 infection among healthcare workers and discover relation between the time of COVID 19 viral clearance resolution of symptoms

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

May 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

May 28, 2020

Last Update Submit

June 1, 2020

Conditions

Infection, Coronavirus

Outcome Measures

Primary Outcomes (1)

  • the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms.

    different relations between different symptoms, investigation results and time of viral clearness

    basline

Secondary Outcomes (1)

  • knowledge and practice of infection control measures

    baseline

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Covid 19 infected healthcare workers in Assiut University Hospital

You may qualify if:

  • Covid 19 infected healthcare workers.

You may not qualify if:

  • Risky healthcare workers (diabetic hypertensive and more than 50 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

    PMID: 31995857BACKGROUND

  • Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.

    PMID: 29128390BACKGROUND

  • Wang J, Zhou M, Liu F. Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China. J Hosp Infect. 2020 May;105(1):100-101. doi: 10.1016/j.jhin.2020.03.002. Epub 2020 Mar 6. No abstract available.

    PMID: 32147406BACKGROUND

  • Woo PCY, Huang Y, Lau SKP, Yuen KY. Coronavirus genomics and bioinformatics analysis. Viruses. 2010 Aug;2(8):1804-1820. doi: 10.3390/v2081803. Epub 2010 Aug 24.

    PMID: 21994708BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Complete Blood Count (CBC) by (Pentra 80 Horiba blood counter). * Erythrocyte Sedimentation Rate (ESR) by westergren method. * Liver function , Kidney function tests, triglyceride , LDH, CK, CK-MB Na, K, Mg, Phosphorus, Ca, CRP, Ferritin ) (Dimension RXLautomated blood chemistry analyser). * HCV Ab, HBsAg and HIV Ag-Ab on Abott Architect i1000R * Prothrombin time , concentration, INR and D-Dimerand on sysmex 1500 corona virus investigation: Viral RNA extraction by Qiagen viral RNA extraction large volume: on QiAcube extractor * Coronavirus (Covid -19) genesig Real time PCR assay : on 7500 fast Applied biosystem

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Mariam elkhayat, lecturer

CONTACT

00201003708261mariam.elkhayat@aun.edu.eg

Azza Ezzeldin, professor

CONTACT

01001918207Azzam80@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 1, 2020

Study Start

June 1, 2020

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

June 4, 2020

Record last verified: 2020-06