SARS-COV2 Pandemic Serosurvey in a Rare Disease Population

NCT ID: NCT04609085

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 730 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2022-06-08

Brief Summary

Background:

The SARS-COV2 outbreak has had a major impact on the economy and society. Researchers want to learn how widespread the infection is in the rare disease community. To do this, they will get blood samples from people with rare diseases. They will use at-home sampling. This will allow them to get samples from people across a wide area.

Objective:

To estimate the proportion of people with rare diseases who have SARS-COV2 antibodies in the National Center for the Advancement of Translational Sciences Rare Disease Clinical Research Network (RDCRN) Rare Diseases Survey over time.

Eligibility:

People under age 90 who have a rare disease and have taken part in the Cincinnati Children s Hospital Medical Center (CCHMC) protocol# 2020-0299.

Design:

RDCRN will tell CCHMC participants about this NIH study. RDCRN will only reach out to those who agreed to be contacted for future studies. They will be contacted by phone and email.

Participants will have a virtual visit to collect data. It will take place over the phone.

Participants will be sent a home kit to collect a blood sample. The kit contains gauze, a lancet, bandages, a collection device, and instructions. They will also be given shipping materials. They will give up to 80ul of blood. They will ship the sample back to NIH.

Participants will complete a survey. It can be done online or over the phone.

Participation will last for 1 week....

Detailed Description

It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-COV2 virus, have a major impact on morbidity and mortality worldwide, as well as having devastating global economic and societal impact. During these outbreaks it is critical to gain a rapid understanding of the exposures and immunity in the general population. Current ongoing serosurvey efforts to estimate the prevalence of infection/exposure are focused on the general population, but these estimates may not be applicable to individuals living with rare diseases. An effort to identify the impact of this pandemic on this community is underway in the Rare Disease Clinical Research Network (RDCRN) led by the Data Management and Coordinating Center (DMCC) at Cincinnati Children s Hospital Medical Center (CCHMC) supported by NCATS. Through a survey they are attempting to evaluate infection rates and impact on those with rare diseases. In this study we propose to enroll a subset of the individuals participating in the RDCRN study to collect blood for SARS-Cov-2 antibody testing. This will allow us to add a biological marker to confirm infection/exposure and further our understanding of how widespread this infection is in the rare diseae community.

Conditions

SARS-COV2 Virus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with Rare Diseases

Participants with history of rare disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. <90 years of age.

2. Participant in CCHMC Protocol# 2020-0299.

3. Will have expressed interest in discussing this study with us when contacted by CCHMC Protocol# 2020-0299 study team.

4. Willing and able to complete a verbal telephone consent or, has a parent/guardian or Legally Authorized Representative (LAR) able to complete the consent.

5. Willing to undergo home blood sampling procedures.

6. Willing to have blood samples stored for future research.

Exclusion Criteria

1. Unable to provide consent and/or does not have a parent, guardian, or LAR to provide consent

2. Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study s scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include having an acute respiratory infection that would make it unsafe to obtain blood samples.

3. Not willing to have blood samples stored for future research.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew J Memoli, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

000210-I

Identifier Type: -

Identifier Source: secondary_id

10000210

Identifier Type: -

Identifier Source: org_study_id