COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH

• Conditions: COVID 19
• Interventions: Diagnostic Test: Serology Test

• Registration Number: NCT04469647
• Lead Sponsor: Johns Hopkins Aramco Healthcare

Brief Summary

Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably.

Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-14
• Study Start: 2020-07-19
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29
• Primary Completion: 2021-01-15
• Study Completion: 2021-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Adult.
2. JHAH employee
3. Housekeepers (this group of staff are outsourced at JHAH)

Exclusion Criteria

1. Any participant exhibiting COVID 19 symptoms

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-risk	Serology Test	Employees working at lower risk areas such as (administration, HR, Public relations)
High-risk	Serology Test	Employees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers)

Primary Outcome Measures

Name	Time	Method
Seroconversion status	6 Months	Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.

Secondary Outcome Measures

Name	Time	Method
Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers	6 Months	Age, gender, type of staff, resources
The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH	6 Months	To identify the durability of antibody seroconversion
The proportion of asymptomatic infections among staff who have seroconverted	6 Months	Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain)

Trial Locations

Locations (1)

Johns Hopkins Aramco Healthcare; 🇸🇦 Dhahran, Eastern, Saudi Arabia