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

Covid19 Clinical Trial

Official title:

Seroprevalence of SARS-CoV 2 Among Asymptomatic Frontline Healthcare Workers During COVID 19: A Cross Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563247
• Other study ID #: LGH002
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: February 8, 2021

Study information

• Verified date: February 2022
• Source: Lahore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 970
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2021
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• IgG SARS CoV 2 antibodies
The asymptomatic healthcare workers of high exposure COVID19 areas will be tested for IgG SARS CoV 2 antibodies

Locations

Country	Name	City	State
Pakistan	Lahore General Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS CoV 2 IgG antibodies	The presence or absence of SARS CoV 2 antibodies in serum of HCWs	3 months