ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

March 15, 2023 updated by: Columbia University

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

Intervention / Treatment

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 (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Up to 12 months after collection visit
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

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2020

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

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)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronavirus Infection

Clinical Trials on COVID-19 Serology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe