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

SARS-CoV-2 Clinical Trial

— HEROS  

Official title:

Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375761
• Other study ID #: DAIT-COVID-19-001
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: March 29, 2021

Study information

• Verified date: May 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5599
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• COVID-19
• SARS-CoV-2

Intervention

Procedure:
• Collection of Biological Samples
Biological samples will be collected throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. All biological samples (e.g. nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. At the end of study, additional samples (e.g. nasal secretion and/or saliva samples) may be collected by the family or study staff at a site visit, if feasible.
• Symptom and Exposure Surveys
Symptom and exposure surveys (questionnaires) will be completed throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. The primary household contact/caregiver will be the designee for ensuring timely questionnaires completion and submission for all household study participants.

Locations

Country	Name	City	State
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	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	Boston Medical Center: Inner City Asthma Consortium (ICAC) Site	Boston	Massachusetts
United States	Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) 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	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	Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site	Dallas	Texas
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	University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site	Madison	Wisconsin
United States	Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site	Nashville	Tennessee
United States	Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site	New York	New York
United States	St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site	Saint Louis	Missouri
United States	Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Rho Federal Systems Division, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period	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.	Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)
Secondary	Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period	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).	Up to Week 24
Secondary	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	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.	Up to Week 24
Secondary	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	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).	Through study completion, an average of 24 Weeks
Secondary	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	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.	Up to Week 24
Secondary	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	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.	Up to Week 24
Secondary	Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period	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.	Up to Week 24
Secondary	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	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	Up to Week 24
Secondary	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	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.	Up to Week 24
Secondary	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	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.	Baseline, Week 24