Sponsor study identifier
Secondary identifiers
observational
730
1 country
2
Study Start
April 19, 2021
Actual (reported)Primary Completion
June 8, 2022
Actual (reported)Study Completion
June 8, 2022
Actual (reported)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....
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 8, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 29, 2020
Actual (reported)October 30, 2020
Actual (reported)April 19, 2021
Actual (reported)June 8, 2022
Actual (reported)June 8, 2022
Actual (reported)To estimate the proportion of people with rare diseases who have detectable antibodies to SARS-COV2 in the NCATS RDCRN Rare Diseases Survey.
Anti-SARS-COV2 IgG, IgA, and IgM measured by ELISA
2 years
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).
2 years
Participants with history of rare disease
Participants who are enrolled in CCHMC protocol# 2020-0299 Impact of COVID-19 on People Living with Rare Diseases and their Families.
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Matthew J Memoli, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
730 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2020
First Posted
October 30, 2020
Study Start
April 19, 2021
Actual (reported)CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)
Contact the study team to confirm eligibility.
Primary Completion
June 8, 2022
Actual (reported)Study Completion
June 8, 2022
Actual (reported)Last Updated
August 15, 2024
Record last verified: 2024-08
.IDP will be made available through the NCI Seronet and clinical trials.gov. IDP that underlies the results in a publication will be shared.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: