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NCT04367857 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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