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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Households; SARS CoV 2 Infection

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 Type: Observational
• Enrollment (Estimated): 374

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10031
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Index case is positive and all household members are positive

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Delivette Castor, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: AAAS9688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No