COVID-19NCT05467917
ARMOR-Household: Characterizing Transmission of COVID-19 in Households of SARS-CoV-2 Index Cases
An observational study of COVID-19 and Households, run by Columbia University at 1 site in United States.
Trial summary
The goal of this project is to understand the household level transmission dynamics and factors that predict transmission of SARS-COV-2 between pediatric and adults in the household. The novel coronavirus SARS-CoV-2 has spread all around the world and testing has posed a challenge globally. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Households, SARS CoV 2 Infection
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Dec 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pediatric patients, New York Presbyterian health workers, and any individual who has been exposed to SARS-CoV-2 cases and their household contacts residing in New York City.
Who may be able to join
- Index is a positive child AND at least one household member is negative
- OR
- Index is a positive symptomatic / asymptomatic New York Presbyterian Hospital (NYP) and affiliates worker or any individual AND at least one household member is negative
- OR
- Either Index case is negative, exposed to a confirmed positive SARS-CoV-2 case, AND at least one household members is negative
Who cannot join
- Index case is positive and all household members are positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10031
About this study
Official title: ARMOR-Household: Characterizing Transmission of COVID-19 in Households of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Index Cases
The goal of this project is to understand the household level transmission dynamics and factors that predict transmission of SARS-COV-2 between pediatric and adults in the household.
The novel coronavirus SARS-CoV-2 has spread all around the world and testing has posed a challenge globally. Not much is known about who does and does not acquire SARS-CoV2. It is also unknown who will show symptoms or progress severe disease or death from COVID-19. Children tend to have milder symptoms or none at all. Therefore, few children have ever been tested, so it is unknown if they get the infection as much as anyone else. Health care providers are highly exposed, and they do not get tested unless they show severe symptoms. If groups like children and health workers are infected, they can unknowingly spread SARS-CoV-2, unless they practice behaviors like self-isolation very strictly. The investigators aim to measure the prevalence of SARS-CoV-2 in children and health care workers at a large urban health center. The investigators will also measure how many people in the household of the positive children and health care workers also get SARS-CoV-2 infection. Lastly, the investigators will see what other risk factors affect who acquires SARSCoV-2 from inside or outside of the household clusters.
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. Little is known about transmission and disease presentation of COVID-19. Children tend to present with mild or no symptoms, and only a minority seem to progress to severe disease. Therefore, fewer have been tested. Health care providers who are highly exposed are under tested for their level of exposure. Under diagnoses in these groups can result in onward transmission of SARS-CoV-2 if non-pharmaceutical interventions like self-isolation are not strictly practiced. The investigators aim to assess the prevalence of SARS-CoV-2 in a pediatric, health care worker and other individuals sample in a large urban health center; Estimate the household secondary attack rate of SARS-COV-2 from the pediatric and adult index case SARS-COV-2 identified through the prevalence survey; and identify risk factors that affect transmission from within and outside of the household clusters.
This is an observational prospective cohort study of pediatric patients, New York Presbyterian (and affiliates) health workers, and any individuals who have been exposed to SARS-CoV-2 cases and their household contacts residing in New York City. Child index and their household members who consent to participate will be enrolled and tested for SARS-CoV-2. Households will be followed prospectively for a minimum of 15 days from the date the last household member testing positive. Daily clinical symptom reporting, social distancing behaviors within and outside of the household, emotional and mental health factors such anxiety, stigma and disclosure (among SARS-CoV-2 diagnosed) will be reported by adult household members and minors over the age of 7. Adults will report signs and symptoms for minors under the age of 7. SARS-CoV-2 negative household members will be re-tested around the day of onset of symptoms and baseline negative household members will be tested at the end of the observation period. A proportion of SARS-CoV-2 positive household members will be sampled serially for viral shedding and would be sampled on the day of onset of exposure. Households where all members are positive at baseline visit will be excluded from participation.
- Conditions
- COVID-19, Households, SARS CoV 2 Infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Index Case | a) minor testing positive for SARS-CoV-2; b) symptomatic health workers or any individual with a history of exposure to SARS-CoV-2 confirmed positive patients; c) health workers or any individual who tests positive regardless of symptoms. Index case must be living in a multi-person household that includes at least one child with a history of exposure to SARS-CoV-2 positive patients | |
| Household Contact | Anyone residing in the house for at least 24 hours at the time of the index case diagnosis or study enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period prevalence of SARS-CoV-2 Infection
Period prevalence of SARS-CoV-2 infection as detected by use of home nasal swab and blood samples. At home nasal swab every 48-72 hours for about 15 days, with another potential collection on day 21 and day 28 of the study. Blood sample collected at enrollment and at day 28.
Measured: Up to 28 days
Household secondary attack rate of SARS-COV-2
Household secondary attack rate of SARS-COV-2 from the pediatric and adult index case SARS-COV-2 identified through the prevalence survey in outcome 1. SARS-CoV-2 negative household members will be re-tested around the day of onset of symptoms and baseline negative household members will be tested at the end of the observation period. A proportion of SARS-CoV-2 positive household members will be sampled serially for viral shedding and would be sampled on the day of onset of exposure.
Measured: Up to 28 Days
Identify risk factors associated within and extra-household transmission of SARS-CoV-2
Identify sociodemographic, behavioral (e.g., social distancing behaviors within and outside of the household), clinical, and viral risk factors associated within and extra-household transmission of SARS-CoV-2 overall and by type of index cases. Daily clinical symptom reporting, social distancing behaviors within and outside of the household, emotional and mental health factors such anxiety, stigma and disclosure (among SARS-CoV-2 diagnosed) will be reported by adult household members and minors over the age of 7.
Measured: Up to 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Aug 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Delivette Castor, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467917
- Sponsor's protocol ID
- AAAS9688
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARMOR-Household: Characterizing Transmission of COVID-19 in Households of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Index Cases
- ClinicalTrials.gov ID
- NCT05467917
- Acronym / sponsor ID
- AAAS9688
- Conditions
- COVID-19, Households, SARS CoV 2 Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jul 2022 (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 goal of this project is to understand the household level transmission dynamics and factors that predict transmission of SARS-COV-2 between pediatric and adults in the household.
The novel coronavirus SARS-CoV-2 has spread all around the world and testing has posed a challenge globally. Not much is known about who does and does not acquire SARS-CoV2. It is also unknown who will show symptoms or progress severe disease or death from COVID-19. Children tend to have milder symptoms or none at all. Therefore, few children have ever been tested, so it is unknown if they get the infection as much as anyone else. Health care providers are highly exposed, and they do not get tested unless they show severe symptoms. If groups like children and health workers are infected, they can unknowingly spread SARS-CoV-2, unless they practice behaviors like self-isolation very strictly. The investigators aim to measure the prevalence of SARS-CoV-2 in children and health care workers at a large urban health center. The investigators will also measure how many people in the household of the positive children and health care workers also get SARS-CoV-2 infection. Lastly, the investigators will see what other risk factors affect who acquires SARSCoV-2 from inside or outside of the household clusters.
Detailed description
The rapid spread of the novel coronavirus SARS-CoV-2 has resulted in pandemic levels and a global challenge in diagnosing infection. Little is known about transmission and disease presentation of COVID-19. Children tend to present with mild or no symptoms, and only a minority seem to progress to severe disease. Therefore, fewer have been tested. Health care providers who are highly exposed are under tested for their level of exposure. Under diagnoses in these groups can result in onward transmission of SARS-CoV-2 if non-pharmaceutical interventions like self-isolation are not strictly practiced. The investigators aim to assess the prevalence of SARS-CoV-2 in a pediatric, health care worker and other individuals sample in a large urban health center; Estimate the household secondary attack rate of SARS-COV-2 from the pediatric and adult index case SARS-COV-2 identified through the prevalence survey; and identify risk factors that affect transmission from within and outside of the household clusters.
This is an observational prospective cohort study of pediatric patients, New York Presbyterian (and affiliates) health workers, and any individuals who have been exposed to SARS-CoV-2 cases and their household contacts residing in New York City. Child index and their household members who consent to participate will be enrolled and tested for SARS-CoV-2. Households will be followed prospectively for a minimum of 15 days from the date the last household member testing positive. Daily clinical symptom reporting, social distancing behaviors within and outside of the household, emotional and mental health factors such anxiety, stigma and disclosure (among SARS-CoV-2 diagnosed) will be reported by adult household members and minors over the age of 7. Adults will report signs and symptoms for minors under the age of 7. SARS-CoV-2 negative household members will be re-tested around the day of onset of symptoms and baseline negative household members will be tested at the end of the observation period. A proportion of SARS-CoV-2 positive household members will be sampled serially for viral shedding and would be sampled on the day of onset of exposure. Households where all members are positive at baseline visit will be excluded from participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index Case | – | –a) minor testing positive for SARS-CoV-2; b) symptomatic health workers or any individual with a history of exposure to SARS-CoV-2 confirmed positive patients; c) health workers or any individual who tests positive regardless of symptoms. Index case must be living in a multi-person household that includes at least one child with a history of exposure to SARS-CoV-2 positive patients |
| Household Contact | – | –Anyone residing in the house for at least 24 hours at the time of the index case diagnosis or study enrollment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients, New York Presbyterian health workers, and any individual who has been exposed to SARS-CoV-2 cases and their household contacts residing in New York City.
Key inclusion criteria (5 listed)
- Index is a positive child AND at least one household member is negative
- OR
- Index is a positive symptomatic / asymptomatic New York Presbyterian Hospital (NYP) and affiliates worker or any individual AND at least one household member is negative
- OR
- Either Index case is negative, exposed to a confirmed positive SARS-CoV-2 case, AND at least one household members is negative
Key exclusion criteria (1 listed)
- Index case is positive and all household members are positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Period prevalence of SARS-CoV-2 Infection
Time frame: Up to 28 days
Period prevalence of SARS-CoV-2 infection as detected by use of home nasal swab and blood samples. At home nasal swab every 48-72 hours for about 15 days, with another potential collection on day 21 and day 28 of the study. Blood sample collected at enrollment and at day 28.
Household secondary attack rate of SARS-COV-2
Time frame: Up to 28 Days
Household secondary attack rate of SARS-COV-2 from the pediatric and adult index case SARS-COV-2 identified through the prevalence survey in outcome 1. SARS-CoV-2 negative household members will be re-tested around the day of onset of symptoms and baseline negative household members will be tested at the end of the observation period. A proportion of SARS-CoV-2 positive household members will be sampled serially for viral shedding and would be sampled on the day of onset of exposure.
Identify risk factors associated within and extra-household transmission of SARS-CoV-2
Time frame: Up to 28 Days
Identify sociodemographic, behavioral (e.g., social distancing behaviors within and outside of the household), clinical, and viral risk factors associated within and extra-household transmission of SARS-CoV-2 overall and by type of index cases. Daily clinical symptom reporting, social distancing behaviors within and outside of the household, emotional and mental health factors such anxiety, stigma and disclosure (among SARS-CoV-2 diagnosed) will be reported by adult household members and minors over the age of 7.
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Delivette Castor, PhD 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 Households, 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period prevalence of SARS-CoV-2 Infection (time frame: Up to 28 days). The study lists 3 primary outcomes in all. 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 11 Sep 2026.