SARS-COV2 Pandemic Serosurvey in a Rare Disease Population
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|ClinicalTrials.gov Identifier: NCT04609085|
Recruitment Status : Completed
First Posted : October 30, 2020
Last Update Posted : May 31, 2023
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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.
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.
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.
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||730 participants|
|Official Title:||SARS-COV2 Pandemic Serosurvey in a Rare Disease Population|
|Actual Study Start Date :||April 19, 2021|
|Actual Primary Completion Date :||June 8, 2022|
|Actual Study Completion Date :||June 8, 2022|
Participants with Rare Diseases
Participants with history of rare disease
- To estimate the proportion of people with rare diseases who have detectable antibodies to SARS-COV2 in the NCATS RDCRN Rare Diseases Survey. [ Time Frame: 2 years ]Anti-SARS-COV2 IgG, IgA, and IgM measured by ELISA
- To estimate the proportion of detectable antibodies across specific categories of rare diseases (e.g., people who live with rare diseases characterized by immune compromise vs. people with hyper-reactivity of the immune system). [ Time Frame: 2 years ]Variation in the Observed-to-expected ratio of people with detectable Anti-SARS-COV2 IgG, IgA, and IgM measured by ELISA (seroprevalent cases), across subgroups of people with different categories of rare diseases.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||up to 90 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- <90 years of age.
- Participant in CCHMC Protocol# 2020-0299.
- Will have expressed interest in discussing this study with us when contacted by CCHMC Protocol# 2020-0299 study team.
- Willing and able to complete a verbal telephone consent or, has a parent/guardian or Legally Authorized Representative (LAR) able to complete the consent.
- Willing to undergo home blood sampling procedures.
- Willing to have blood samples stored for future research.
- Unable to provide consent and/or does not have a parent, guardian, or LAR to provide consent
- 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.
- Not willing to have blood samples stored for future research.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609085
|United States, Maryland|
|National Institute of Allergy and Infectious Diseases (NIAID)|
|Bethesda, Maryland, United States, 20892|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Matthew J Memoli, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||October 30, 2020 Key Record Dates|
|Last Update Posted:||May 31, 2023|
|Last Verified:||July 29, 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.IDP will be made available through the NCI Seronet and clinical trials.gov. IDP that underlies the results in a publication will be shared.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||IPD will be shared starting a maximum of 1 year after publication.|
|Access Criteria:||The IPD will be available publicly.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|