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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Coronavirus Disease 2019 (COVID-19); SARS-CoV-2

Treatments: Procedure: Collection of Biological Samples; Procedure: Symptom and Exposure Surveys

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT04375761

DAIT-COVID-19-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,599 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

5,599 participants in 1 patient group

SARS-CoV-2 Surveillance: Total Group

Description:

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.

Treatment:

Procedure: Symptom and Exposure Surveys

Procedure: Collection of Biological Samples