ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

Covid-19 Clinical Trial

Official title:

SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367857
• Other study ID #: AAAS9998
• Status: Recruiting
• Start date: April 18, 2020
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Brett Gray
• Phone: 212-305-1570
• Email: bg2168[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.

Description:

The rapid spread of the novel coronavirus SARS-CoV-2 has resulted in pandemic levels and a global challenge in diagnosing infection. Diagnosing infection, defining recovery and immunity has been challenging. Health care providers in particular are very interested in knowing their status as they are highly exposed, and if infectious, can potentially transmit infection nosocomially (in the healthcare workplace setting) and to their household. In addition to understanding their exposure risk, infectious period, and immunity status, health care workers are reporting high levels of psychosocial distress including anxiety and burnout. The investigators aim to assess the baseline and cumulative seroprevalence of SARS-CoV-2 among health care workers using both quantitative and qualitative serological assays; describe psychosocial well-being and coping strategies among health workers in their institutional settings and describe how knowledge of one's serostatus affect psychosocial well-being, and coping strategies. Findings from this study will inform; 1) use of serological assays and testing algorithms, and 2) approaches to manage psychosocial stress for healthcare workers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate

• Understands and reads English

Exclusion Criteria:

• Younger than 18 years of age

• Mentally and/or physically unable to complete study requirements

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• Covid-19

Intervention

Other:
• COVID-19 Serology
Quantitate Serology enzyme-linked immunosorbent assay (ELISA) for COVID-19

Behavioral:
• Health Care Worker Survey
The purpose of this survey is to assess how healthcare workers are experiencing and coping with the COVID-19 crisis.

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hosptial/Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion seropositive	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.	Up to 12 months after collection visit