ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04367857
Collaborator
(none)
1,000
1
32.5
30.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project
Actual Study Start Date :
Apr 18, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Proportion seropositive [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NewYork-Presbyterian Hosptial/Columbia University Irving Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT04367857
Other Study ID Numbers:
  • AAAS9998
First Posted:
Apr 29, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022