NCT04445415

Brief Summary

COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab testing as screening method for detection of covid 19 infections among laboratory health care workers ,assess the relationship between the infection with Covid 19 and different laboratory categories/area and assessemt of efficiency personal protective equipment (PPE) in different laboratory categories/area.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

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

June 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 18, 2020

Last Update Submit

June 22, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

  • diagnostic value of COVID-19 antibodies testing

    these serological assays are of critical importance to determine previous exposure,How many people really got infected, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population

    baseline

  • Role of COVID -19 Antibodies testing in treatment of Patients

    these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic method for infected persons

    Baseline

  • Assement of COVID -19 prevalence among healthcare workers

    Serological assay of COVID-19 antibodies testing will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population

    Baseline

Interventions

COVID-19 antibodies testingDIAGNOSTIC_TEST

antibodies aganist COVID-19 detected in the serum of patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the study was carried out using EPI info 2000 statistical package and based on a CDC COVID-19 Response Team report where the prevalence of COVID 19 infected health care workers (CDC, 2020) The minimum calculated sample was 250 health care worker , with confidence interval 80%.

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)

  • Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol. 2020 Apr;42(1):13-21.

    PMID: 32342927BACKGROUND

  • Salathe M, Althaus CL, Neher R, Stringhini S, Hodcroft E, Fellay J, Zwahlen M, Senti G, Battegay M, Wilder-Smith A, Eckerle I, Egger M, Low N. COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation. Swiss Med Wkly. 2020 Mar 19;150:w20225. doi: 10.4414/smw.2020.20225. eCollection 2020 Mar 9.

    PMID: 32191813BACKGROUND

  • Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.

    PMID: 32205334BACKGROUND

  • Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.

    PMID: 32350462BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Samar Salah Eldin

CONTACT

+201117296242samarsalah166@hotmail.com

Azza Ezzeldin, Professor

CONTACT

+201001918207Azzam80@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 24, 2020

Study Start

July 1, 2020

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

June 24, 2020

Record last verified: 2020-06