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NCT04609085 · ClinicalTrials.gov registry record
SARS-COV2 Pandemic Serosurvey in a Rare Disease Population
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 730
- Enrollment target
NCT04609085: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04609085 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 730 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04609085 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 730 participants
- Enrollment target
Study 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....
Primary Outcome
Anti-SARS-COV2 IgG, IgA, and IgM measured by ELISA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2022-06-08 |
What the finished NCT04609085 record still lists
NCT04609085 is an observational study that tracks outcomes without assigning an intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04609085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04609085 about?
NCT04609085 is a clinical study titled "SARS-COV2 Pandemic Serosurvey in a Rare Disease Population". 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...
What is the current status of trial NCT04609085?
This trial is currently completed. The enrollment target is 730 participants. The study started on 2021-04-19. Estimated completion is 2022-06-08.
Who is sponsoring clinical trial NCT04609085?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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