Clinical trial NCT04375761: COVID-19: Human Epidemiology and Response to SARS-CoV-2
Official title: Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2
Keywords: COVID-19
SARS-CoV-2
Public Health Surveillance
Participants in NIH-funded studies (and their families)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Rho Federal Systems Division, Inc.
First posted: 2020-05-05
Enrollment: 5599
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NIH-funded study participants (index participants) and their families This includes participants who have asthma and/or other atopic or allergic conditions, as well as healthy index participants, all with extensive medical information and information on atopic and allergic status available as a result of their participation in an NIH-funded study. As many of these are birth cohort studies, there is extensive information available on the parents. The majority of the families have experience with collection of respiratory samples and completing respiratory questionnaires.

Brief summary: The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death.

The purpose of this study is to:

* Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents
* Determine the prevalence of antibody development over time in children and parents
* Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions
* Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants

Detailed description: The study population will include children that are participants in NIH-funded cohort studies and their families (household contacts).The intent is to recruit families that have experience with the collection of respiratory samples.

The objective of this surveillance study is to identify the rate of infection in children and what, if any effect, atopy has on the SARS-CoV-2 carrier status.

The initial surveillance interval for participants will be 6 months and, depending upon the findings, may be extended. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed remotely via a smart phone, on-line, or phone communications at the time the biological samples are collected.

Eligibility criteria: Inclusion Criteria:

Household members who meet all of the following criteria are eligible for enrollment as study participants:

* The index participant, defined as an individual who either is or has been a participant in an NIH-funded clinical research study from which information on respiratory conditions, including asthma, and other atopic and allergic diseases is available, is:

  * ≤21 years of age, and
  * Lives with caregiver(s).
* The index participant and/or caregiver understands the study procedures and is willing to conduct these procedures at home;
* Have the ability to use either a computer or a smart phone to link to and respond to the study questionnaires:

  --Exception: When the family is willing to speak with a study member to answer the questionnaires in the event of not having access to a computer or a smart phone.
* The index participant and caregiver will reside in the United States, including Puerto Rico, for the duration of the study;
* The index participant will live with the caregiver for at least 50% of the time for the duration of the study;
* An English or Spanish speaker is available to:

  * Serve as the primary contact, and
  * As the person who will be responsible for the completion of questionnaires and the collection of study biological samples; and,
* To participate as a sibling (of the index participant), must be under 21 years of age and live in the same home as the index participant and caregiver.

Exclusion Criteria:

-Past or current medical problems, which, in the opinion of the site investigator may:

* Pose risks from participation in the study
* Interfere with the participant's ability to comply with study requirements, or
* Impact the quality or interpretation of the data obtained from the study.

Primary outcomes:
measure: Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period
timeFrame: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)
Secondary outcomes:
measure: Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Percent of Index Participants With Asthma and Other Atopic Disease With Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
timeFrame: Through study completion, an average of 24 Weeks
measure: Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical Steroids Compared to Index Participants That Are Not Using Topical Steroids Over the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical, Oral, or Inhaled Steroids Compared to Index Participants That Are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period
timeFrame: Up to Week 24
measure: Analysis of Factors, Baseline and Prior History, for Possible Association With the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site
state: Colorado
city: Aurora
country: United States
facility: Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site
state: District of Columbia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago: Food Allergy Outcomes Related to White and African American Racial Differences (FORWARD) and Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) Site
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) Site
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital: School Inner-City Asthma Study (SICAS-2), Environmental Assessment of Sleep in Youth (EASY), Severe Asthma Research Program (SARP) and Preventing Asthma in High Risk Kids (PARK) Site
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center: Inner City Asthma Consortium (ICAC) Site
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System: Childhood Allergy Study (CAS) Site
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center: Greater Cincinnati Pediatric Clinic Repository (GCPCR) and Mechanisms of Progression of Atopic Dermatitis to Asthma in Children (MPAACH) Site
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site
state: Wisconsin
Study officials:
affiliation: Vanderbilt University School of Medicine, Dept. of Medicine
name: Tina V. Hartert, MD, MPH
role: STUDY_CHAIR
References: