Clinical trial NCT04563247: Seroprevalence of SARS-CoV-2 in Asymptomatic Frontline COVID-19 HCWs
Official title: Seroprevalence of SARS-CoV 2 Among Asymptomatic Frontline Healthcare Workers During COVID 19: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Lahore General Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-24
Enrollment: 970
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

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

Primary outcomes:
measure: SARS CoV 2 IgG antibodies
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore General Hospital
state: Punjab
Study officials:
affiliation: LahoreGeneralHospital.Lahore
name: Amina Asif, MPhilMicro
role: PRINCIPAL_INVESTIGATOR
References: