Covid-19NCT04367857
ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers
An observational study of Covid-19 and Coronavirus Infection, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Coronavirus Infection, Coronavirus
- What is being tested?
- COVID-19 Serology and Health Care Worker Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2020to Feb 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employee of NewYork-Presbyterian Hospital and its affiliates
Who may be able to join
- 18 years of age or older
- NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
- Understands and reads English
Who cannot join
- Younger than 18 years of age
- Mentally and/or physically unable to complete study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NewYork-Presbyterian Hosptial/Columbia University Irving Medical Center
New York, New York, 10032
Brett Gray
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid-19, Coronavirus Infection, Coronavirus
- Being tested
- COVID-19 Serology, Health Care Worker Survey
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 SerologyOther
Quantitate Serology enzyme-linked immunosorbent assay (ELISA) for COVID-19
Health Care Worker SurveyBehavioural
The purpose of this survey is to assess how healthcare workers are experiencing and coping with the COVID-19 crisis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: COVID-19 Serology; Behavioral: 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 Receives: Other: COVID-19 Serology; Behavioral: 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) Receives: Other: COVID-19 Serology; Behavioral: Health Care Worker Survey | |
| Never tested and asymptomatic | Never tested and asymptomatic for COVID-19 symptoms, including asymptomatic health care worker Receives: Other: COVID-19 Serology; Behavioral: Health Care Worker Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after collection visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start18 Apr 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena Sobieszczyk, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367857
- Sponsor's protocol ID
- AAAS9998
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project
- ClinicalTrials.gov ID
- NCT04367857
- Acronym / sponsor ID
- AAAS9998
- Conditions
- Covid-19, Coronavirus Infection, Coronavirus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prior Positive polymerase chain reaction (PCR) and Recovered | – | Other: COVID-19 Serology, Behavioral: Health Care Worker SurveyPrior Positive PCR result, fully recovered, back at work and symptom free for greater than or equal than 14 days. |
| Never tested, history of COVID-19 Symptoms and Recovered | – | Other: COVID-19 Serology, Behavioral: Health Care Worker SurveyNever tested and history of COVID-19 symptoms and symptom-free for more than 14 days |
| Never tested and current COVID-19 Symptoms | – | Other: COVID-19 Serology, Behavioral: Health Care Worker SurveyNever tested and current COVID-19 Symptoms (e.g. referred by a provider or clinic) |
| Never tested and asymptomatic | – | Other: COVID-19 Serology, Behavioral: Health Care Worker SurveyNever tested and asymptomatic for COVID-19 symptoms, including asymptomatic health care worker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employee of NewYork-Presbyterian Hospital and its affiliates
Key inclusion criteria (3 listed)
- 18 years of age or older
- NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
- Understands and reads English
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- Mentally and/or physically unable to complete study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 SerologyQuantitate Serology enzyme-linked immunosorbent assay (ELISA) for COVID-19 | Other | Never tested and asymptomatic, Never tested and current COVID-19 Symptoms, Never tested, history of COVID-19 Symptoms and Recovered, Prior Positive polymerase chain reaction (PCR) and Recovered |
| Health Care Worker SurveyThe purpose of this survey is to assess how healthcare workers are experiencing and coping with the COVID-19 crisis. | Behavioural | Never tested and asymptomatic, Never tested and current COVID-19 Symptoms, Never tested, history of COVID-19 Symptoms and Recovered, Prior Positive polymerase chain reaction (PCR) and Recovered |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdalena Sobieszczyk, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Coronavirus Infection, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Gray (212-305-1570, bg2168@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion seropositive (time frame: Up to 12 months after collection visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.