Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Rho Federal Systems Division, Inc.

Conditions:

Coronavirus Disease 2019 (COVID-19)

SARS-CoV-2

Eligibility:

All Genders

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 purpo...

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 co...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 29 2021

Estimated Enrollment :

5599 Patients enrolled

Trial Details

Trial ID

NCT04375761

Start Date

May 1 2020

End Date

March 29 2021

Last Update

August 6 2025

Active Locations (20)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (20 locations)

1

Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site

Aurora, Colorado, United States, 80045

2

Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site

Aurora, Colorado, United States, 80045

3

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site

Washington D.C., District of Columbia, United States, 20010

4

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, 60611