Seroprevalence of SARS-CoV-2 in Asymptomatic Frontline CO... | NCT04563247

Studies
Seroprevalence of SARS-CoV-2 in Asymptomatic Frontline COVID-19 HCWs

NCT04563247

Sponsor

Lahore General Hospital

Status

Completed

Last Update Posted

Feb 15, 2022Actual

Enrollment

970Actual

Phase

Not provided

Conditions

Covid19

Interventions

IgG SARS CoV 2 antibodies

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Feb 8, 2021Actual

Completion Date

Feb 8, 2021Actual

First Submitted Date

Sep 20, 2020

First Submission Date that Met QC Criteria

Sep 20, 2020

First Posted Date

Sep 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2022

Last Update Posted Date

Feb 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amina Asif, Assistant Professor, Lahore General HospitalPrincipal Investigator

Lead Sponsor

Lahore General HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.

Detailed Description

Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear. Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients. Asymptomatic cases are common but to date there are scarce epidemiological surveys that provide a clear percentage of asymptomatic cases.

A large number of healthcare workers have been infected with the virus worldwide, presenting with severe symptoms to no symptoms at all, in which case being diagnosed on contact tracing only. The seropositivity rate in previously undiagnosed healthcare workers has been reported in different regions of the world. In a combined study of three hospitals of Turkey, the seropositivity rate of the previously undiagnosed HCWs was 2.7%. A study done in China revealed 17.5 % seropositivity rate.

This study will aim to comprehensively review the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

970Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asymptomatic frontline HCWs for COVID 19		All healthcare workers who worked in high exposure areas of hospital dealing with COVID 19.	Diagnostic Test: IgG SARS CoV 2 antibodies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IgG SARS CoV 2 antibodies	Diagnostic Test	The asymptomatic healthcare workers of high exposure COVID19 areas will be tested for IgG SARS CoV 2 antibodies	Asymptomatic frontline HCWs for COVID 19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SARS CoV 2 IgG antibodies	The presence or absence of SARS CoV 2 antibodies in serum of HCWs	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All HCWs who had been working in high exposure areas of COVID 19

Exclusion Criteria:

Any HCW of high exposure areas of COVID 19 who suffered from COVID 19 themselves diagnosed on PCR or clinically

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Healthcare workers who have been working in high exposure areas of COVID 19 and havenot developed disease themselves while working in that area

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amina Asif, MPhilMicro	LahoreGeneralHospital.Lahore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lahore General Hospital		Lahore	Punjab Province	54500	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

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