COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH

COVID 19 Antibody Seroprevalence Amongst Healthcare Workers in Johns Hopkins Aramco Healthcare

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.

Study Overview

• Status: Unknown
• Conditions: COVID 19
• Intervention / Treatment: Diagnostic test: Serology Test

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern
    • Dhahran, Eastern, Saudi Arabia, 31311
      • Johns Hopkins Aramco Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthcare workers, divided into two groups (High-risk and Low-risk).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High-risk; Employees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers)	Diagnostic test: Serology Test; Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2). at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test.
Low-risk; Employees working at lower risk areas such as (administration, HR, Public relations)	Diagnostic test: Serology Test; Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2). at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion status	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.	6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins Aramco Healthcare

Publications and helpful links

General Publications

• Mushcab H, Al-Tawfiq JA, Ghamdi M, Babgi A, Amir A, Sheikh SS, Darwisheh A, Alobaid A, Jebakumar AZ, Qahtani S, Al Sagheir A. A Cohort Study of Seroprevalence of Antibodies Against SARS-CoV-2 Infection Among Healthcare Workers at a Tertiary Hospital in Saudi Arabia. Infect Drug Resist. 2022 Aug 10;15:4393-4406. doi: 10.2147/IDR.S369755. eCollection 2022.

Helpful Links

• Coronavirus disease (COVID-19) technical guidance: The Unity Studies: Early Investigations Protocols

Study record dates

Study Major Dates

• Study Start (Anticipated): July 19, 2020
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): June 15, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID 19; Coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB20-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are willing to share our data after collection de-identified. We plan to share the data with WHO for their unity studies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No