NCT04367857

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 2020Feb 2027

Study Start

First participant enrolled

April 18, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6.8 years

First QC Date

April 28, 2020

Last Update Submit

April 3, 2026

Conditions

Covid-19Coronavirus InfectionCoronavirus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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 SerologyBehavioral: Health Care Worker Survey

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 SerologyBehavioral: Health Care Worker Survey

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 SerologyBehavioral: Health Care Worker Survey

Never tested and asymptomatic

Never tested and asymptomatic for COVID-19 symptoms, including asymptomatic health care worker

Other: COVID-19 SerologyBehavioral: Health Care Worker Survey

Interventions

COVID-19 SerologyOTHER

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

Never tested and asymptomaticNever tested and current COVID-19 SymptomsNever tested, history of COVID-19 Symptoms and RecoveredPrior Positive polymerase chain reaction (PCR) and Recovered
Health Care Worker SurveyBEHAVIORAL

The purpose of this survey is to assess how healthcare workers are experiencing and coping with the COVID-19 crisis.

Never tested and asymptomaticNever tested and current COVID-19 SymptomsNever tested, history of COVID-19 Symptoms and RecoveredPrior Positive polymerase chain reaction (PCR) and Recovered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Employee of NewYork-Presbyterian Hospital and its affiliates

You may qualify if:

  • years of age or older
  • NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
  • Understands and reads English

You may not qualify if:

  • Younger than 18 years of age
  • Mentally and/or physically unable to complete study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork-Presbyterian Hosptial/Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSerologic TestsImmunologic TestsInvestigative TechniquesImmunologic Techniques

Study Officials

  • Magdalena Sobieszczyk, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett Gray

CONTACT

212-305-1570bg2168@cumc.columbia.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 29, 2020

Study Start

April 18, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(1)