SARS-COV2 VirusNCT04609085
SARS-COV2 Pandemic Serosurvey in a Rare Disease Population
An observational study of SARS-COV2 Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- SARS-COV2 Virus
- How many people
- 730 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2021to 8 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who are enrolled in CCHMC protocol# 2020-0299 Impact of COVID-19 on People Living with Rare Diseases and their Families.
Who may be able to join
- <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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read more
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....
Read the 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
- Keywords
- COVID-19, Rare Diseases, Antibodies, Natural History
- Medical subject headings
- COVID-19, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Rare Diseases | Participants with history of rare disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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).
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start19 Apr 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV2 VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609085
- Sponsor's protocol ID
- 10000210
- Other IDs
- 000210-I
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2020
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .IDP will be made available through the NCI Seronet and clinical trials.gov. IDP that underlies the results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV2 Pandemic Serosurvey in a Rare Disease Population
- ClinicalTrials.gov ID
- NCT04609085
- Acronym / sponsor ID
- 10000210
- Conditions
- SARS-COV2 Virus
- Keywords
- COVID-19, Rare Diseases, Antibodies, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Rare Diseases | – | –Participants with history of rare disease |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are enrolled in CCHMC protocol# 2020-0299 Impact of COVID-19 on People Living with Rare Diseases and their Families.
Key inclusion criteria (6 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. .IDP will be made available through the NCI Seronet and clinical trials.gov. IDP that underlies the results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-COV2 Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.