ARMOR-Household: Characterizing Transmission of COVID-19 in Households of SARS-CoV-2 Index Cases

NCT05467917 | Active Not Recruiting

• 1 other identifier: AAAS9688
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19; Households; SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 28 Days

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Index is a positive child AND at least one household member is negative
• 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
• Either Index case is negative, exposed to a confirmed positive SARS-CoV-2 case, AND at least one household members is negative

You may not qualify if:

• Index case is positive and all household members are positive

Sponsors & Collaborators

• Columbia University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10031, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Optional genetic testing will be performed on saliva and cells collected from the participant's and household's swab, saliva, and blood.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Delivette Castor, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)