COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH

COVID 19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04469647
• Other study ID #: IRB20-09
• Status: Enrolling by invitation
• Start date: July 19, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2020
• Source: Johns Hopkins Aramco Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: June 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Johns Hopkins Aramco Healthcare	Dhahran	Eastern

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Aramco Healthcare

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH	To identify the durability of antibody seroconversion	6 Months
Secondary	Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers	Age, gender, type of staff, resources	6 Months

External Links

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