ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infection; Covid-19; Coronavirus
• Intervention / Treatment: Other: COVID-19 Serology; Behavioral: Health Care Worker Survey

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Brett Gray; Phone Number: 212-305-1570; Email: bg2168@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • NewYork-Presbyterian Hosptial/Columbia University Irving Medical Center
      • Contact: Brett Gray

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Employee of NewYork-Presbyterian Hospital and its affiliates

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prior Positive polymerase chain reaction (PCR) and Recovered; Prior Positive PCR result, fully recovered, back at work and symptom free for greater than or equal than 14 days.	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.
Never tested, history of COVID-19 Symptoms and Recovered; Never tested and history of COVID-19 symptoms and symptom-free for more than 14 days	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.
Never tested and current COVID-19 Symptoms; Never tested and current COVID-19 Symptoms (e.g. referred by a provider or clinic)	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.
Never tested and asymptomatic; Never tested and asymptomatic for COVID-19 symptoms, including asymptomatic health care worker	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Magdalena Sobieszczyk, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests; Serologic Tests; COVID-19 Testing; COVID-19 Serological Testing
• Other Study ID Numbers: AAAS9998

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No