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COV2Base-A Rare Disease by COVID Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564274
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : November 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

SARS-CoV-2 is the virus that causes COVID. It has caused a global pandemic. Most people have no to mild symptoms. But some people need to be hospitalized, and a small number need critical care. Older age as well as some socio-demographic factors and chronic health conditions may play a role in the severity of COVID. In this study, researchers want to assess population-, disease-, and gene-based risks for features associated with severe SARS-CoV-2 outcomes.

Objective:

To measure the frequency and severity of COVID infection in people with rare and common diseases, looking for conditions that increase risk of severe outcomes.

Eligibility:

People greater than 1 month of age, both with and without rare disease, who have access to the Internet.

Design:

This study will take place online.

Participants will visit a website. They will fill out a survey. It should take less than 30 minutes to complete. They will answer questions about their current health and COVID exposures. They will answer questions about their demographic and location features that may impact their exposure to the virus. All questions are optional.

Participants may repeat the survey in 6 to 12 months.

Participants medical records may be reviewed.

Participants may be contacted for future studies related to:

  • COVID
  • Their underlying health conditions
  • A new exposure that is being studied.

Condition or disease
Chronic Health Conditions Older Age is Associated With Increased Pathogenicity

Detailed Description:

Study Description:

This protocol will collect information on frequency and severity of COVID infection for patients with rare diseases and community controls.

Study Objectives:

Primary Objective: To quantify the frequency and severity of COVID infection in patients with rare and common diseases, looking for conditions that increase risk of severe outcomes.

Secondary Objective: To identify gene-, tissue- or sociodemographic level features that increase risk of severe COVID outcomes that may inform future genetic modifier studies.

Endpoints:

Primary Endpoint: Frequency of severe infection (hospitalization +/- ICU stay and/or COVID-related death) secondary to COVID in patients with a shared disease designation.

Secondary Endpoint: Frequency of severe infection (hospitalization +/- ICU stay and/or COVID-related death) secondary to COVID in patients with shared organ system involvement, secondary comorbidities, or sociodemographic differences.

AND Frequency of any infection secondary to COVID in study patients as grouped by genetic diagnosis, organ system involvement, secondary comorbidities, or sociodemographic features.

Study Population:

The study will include people greater than 1 month old, with and without rare disease. Some members of the study population have cognitive impairment on the basis of their rare disease.

Description of Sites/Facilities Enrolling Participants:

All consent and study procedures/questionnaire will be performed online.

Study Duration:

The study will enroll for up to 13 months.

Participant Duration:

After consent, participants (or their legal authorized representative) will be asked to fill out an online questionnaire that should take <30 minutes. We may re-send the survey to the participants in 6 - 12 months. Filling out the second round questionnaire is preferred but not required. New enrollees at the time the 2nd questionnaire is sent will fill out the questionnaire once at Time 2. Participants will be consented for re-contact.

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Study Type : Observational
Estimated Enrollment : 120000 participants
Observational Model: Other
Time Perspective: Other
Official Title: Natural History Study: COV2Base-a Rare Disease by COVID Study
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rare Diseases

Group/Cohort
1
patients with rare and common diseases



Primary Outcome Measures :
  1. To quantify the frequency and severity of COVID infection in patients with rare and common diseases, looking for conditions that increase risk of severe outcomes. [ Time Frame: 12 months ]
    To quantify the frequency and severity of COVID infection in patients with rare and common diseases, looking for conditions that increase risk of severe outcomes.


Secondary Outcome Measures :
  1. To identify gene-, tissue- or sociodemographic level features that increase risk of severe COVID outcomes that may inform future genetic modifier studies. [ Time Frame: 13 months ]
    To identify gene-, tissue- or sociodemographic level features that increase risk of severe COVID outcomes that may inform future genetic modifier studies.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study groups (those being reported upon) include those with known rare medical conditions and those without (community populations). Some individuals being reported on may be children or those with cognitive impairment.
Criteria
  • INCLUSION CRITERIA:

The person being reported upon must be 1 month of age or older. The reporter must have access to the internet and be able to read and answer questions in English or Spanish.

EXCLUSION CRITERIA:

Individuals unwilling to allow sharing of their research data should not participate. With the use of online consents for large numbers of individuals, opting in or out of sharing for this low risk study creates a burden for this research study as well as the ability to share data with other related research studies for meta-analysis.


Information from the National Library of Medicine

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): NCT04564274


Contacts
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Contact: Sharon Osgood, R.N. (301) 827-3237 sharon.osgood@nih.gov

Locations
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United States, Maryland
National Heart, Lung and Blood Institute (NHLBI) Recruiting
Bethesda, Maryland, United States, 20892
Contact: Sharon Osgood, M.S.    301-827-3237    sharon.osgood@nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Beth A Kozel, M.D. National Heart, Lung, and Blood Institute (NHLBI)
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT04564274    
Other Study ID Numbers: 10000091
000091-H
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: November 26, 2020
Last Verified: October 28, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Modifier of Disease
Precision Medicine
Common Diseases
Increase Risk of Severe Outcomes
Gene-Based Risk
Additional relevant MeSH terms:
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Rare Diseases
Disease Attributes
Pathologic Processes