COVID-19: Human Epidemiology and Response to SARS-CoV-2

Completed

• Conditions: SARS-CoV-2; Coronavirus Disease 2019 (COVID-19)
• Interventions: Procedure: Collection of Biological Samples; Procedure: Symptom and Exposure Surveys

• Registration Number: NCT04375761
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study First Submitted: 2020-04-30
• Study Start: 2020-05-01
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Primary Completion: 2021-03-29
• Study Completion: 2021-03-29
• Results First Submitted: 2023-08-17
• Results First Submitted QC: 2023-11-16
• Results First Posted: 2023-12-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5599

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 Surveillance: Total Group	Symptom and Exposure Surveys	Participants either currently or in the past, enrolled in National Institutes of Health (NIH)-funded cohort studies, and their families (household contacts). Active surveillance for detection of SARS-CoV-2 for 6 months, beginning with enrollment. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed at the time that biological samples are collected.
SARS-CoV-2 Surveillance: Total Group	Collection of Biological Samples	Participants either currently or in the past, enrolled in National Institutes of Health (NIH)-funded cohort studies, and their families (household contacts). Active surveillance for detection of SARS-CoV-2 for 6 months, beginning with enrollment. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed at the time that biological samples are collected.

Primary Outcome Measures

Name	Time	Method
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period	Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)	Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.

Secondary Outcome Measures

Name	Time	Method
Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period	Up to Week 24	Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts.; Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
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	Up to Week 24	Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis.; Total RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.
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	Up to Week 24	Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.; Testing method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.
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	Up to Week 24	Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed.; Definition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.
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	Baseline, Week 24	An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.
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	Through study completion, an average of 24 Weeks	Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.; Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period	Up to Week 24	An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted.; Included in analysis: Index participants and their household contacts.
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	Up to Week 24	Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.; Tests: Positive for SARS-CoV-2 RNA in nasal samples
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	Up to Week 24	Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.; Tests: Positive for SARS-CoV-2 RNA in nasal samples.

Trial Locations

Locations (20)

Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) Site; 🇺🇸 Boston, Massachusetts, United States

Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Cincinnati, Ohio, United States

Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site; 🇺🇸 Nashville, Tennessee, United States

Boston Medical Center: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Boston, Massachusetts, United States

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; 🇺🇸 Chicago, Illinois, United States

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Washington, District of Columbia, United States

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; 🇺🇸 Cincinnati, Ohio, United States

Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 New York, New York, United States

University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Dallas, Texas, United States

Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site; 🇺🇸 Cincinnati, Ohio, United States

St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Saint Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site; 🇺🇸 Cincinnati, Ohio, United States

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; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health System: Childhood Allergy Study (CAS) Site; 🇺🇸 Detroit, Michigan, United States

Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Detroit, Michigan, United States

Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site; 🇺🇸 Detroit, Michigan, United States

University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site; 🇺🇸 Madison, Wisconsin, United States

Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site; 🇺🇸 Aurora, Colorado, United States

Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site; 🇺🇸 Aurora, Colorado, United States

University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site; 🇺🇸 Madison, Wisconsin, United States