Chronic Health ConditionsNCT04564274
COV2Base-A Rare Disease by COVID Study
An observational study of Chronic Health Conditions and Older Age is Associated With Increased Pathogenicity, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Chronic Health Conditions, Older Age is Associated With Increased Pathogenicity
- How many people
- 1,748 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2020to 20 May 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 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Natural History Study: COV2Base-a Rare Disease by COVID Study
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 sociodemographic-, population-, disease-, and gene-based risks for features associated with severe SARS-CoV-2 outcomes. As more is understood about COVID, researchers also want to learn more about people s experiences with COVID vaccines, long-haul symptoms, and other related disease features.
Read more
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. To describe experiences with COVID vaccines, symptoms, and other features of COVID in people with rare and common diseases.
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 experiences. 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 if their responses indicate a need for follow-up.
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....
Read the 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.
Tertiary Objective (exploratory): To investigate the role of pre- existing disease- or socioeconomic- factors that contribute to COVID- related stress and to evaluate whether individuals with the conditions studied experience more extreme symptoms around the time of COVID vaccine.
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 or symptoms (including long haul symptoms) secondary to COVID in study patients as grouped by genetic diagnosis, organ system involvement, secondary comorbidities, or sociodemographic features.
Tertiary Endpoints (exploratory): Frequency and degree of COVID related stress based on pre-existing disease-, organ system-, or socioeconomic- factors and frequency of extreme symptoms following one of the COVID vaccines based on pre-existing disease-organ system-, or socioeconomic- factors.
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. If a signal for increased symptoms is identified in one or more studied groups, individuals from that group may be re-contacted with additional questions or request for medical records within the 13 month window. Participants will be consented for re-contact.
- Keywords
- Modifier of Disease, Precision Medicine, Common Diseases, Increase Risk of Severe Outcomes, Gene-Based Risk, Natural History
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 |
|---|---|---|
| 1 | patients with rare and common diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 12 months
Secondary outcomes (1)
To identify gene-, tissue- or sociodemographic level features that increase risk of severe COVID outcomes that may inform future genetic modifier studies.
To identify gene-, tissue- or sociodemographic level features that increase risk of severe COVID outcomes that may inform future genetic modifier studies.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start4 Oct 2020
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Health ConditionsStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
- Other
- Time perspective
- Other
- Enrolment
- 1,748 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Beth A Kozel, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564274
- Sponsor's protocol ID
- 10000091
- Other IDs
- 000091-H
- Status last verified
- Jan 2023
- First submitted
- 24 Sep 2020
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study: COV2Base-a Rare Disease by COVID Study
- ClinicalTrials.gov ID
- NCT04564274
- Acronym / sponsor ID
- 10000091
- Keywords
- Modifier of Disease, Precision Medicine, Common Diseases, Increase Risk of Severe Outcomes, Gene-Based Risk, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,748 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 25 Sep 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:
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 sociodemographic-, population-, disease-, and gene-based risks for features associated with severe SARS-CoV-2 outcomes. As more is understood about COVID, researchers also want to learn more about people s experiences with COVID vaccines, long-haul symptoms, and other related disease features.
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. To describe experiences with COVID vaccines, symptoms, and other features of COVID in people with rare and common diseases.
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 experiences. 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 if their responses indicate a need for follow-up.
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....
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.
Tertiary Objective (exploratory): To investigate the role of pre- existing disease- or socioeconomic- factors that contribute to COVID- related stress and to evaluate whether individuals with the conditions studied experience more extreme symptoms around the time of COVID vaccine.
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 or symptoms (including long haul symptoms) secondary to COVID in study patients as grouped by genetic diagnosis, organ system involvement, secondary comorbidities, or sociodemographic features.
Tertiary Endpoints (exploratory): Frequency and degree of COVID related stress based on pre-existing disease-, organ system-, or socioeconomic- factors and frequency of extreme symptoms following one of the COVID vaccines based on pre-existing disease-organ system-, or socioeconomic- factors.
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. If a signal for increased symptoms is identified in one or more studied groups, individuals from that group may be re-contacted with additional questions or request for medical records within the 13 month window. Participants will be consented for re-contact.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with rare and common diseases |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 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.
1 secondary outcome
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
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 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Health Conditions
RecruitingPhase 4
A Research Study Looking at Kidney and Heart Health in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China
Cardiovascular Risk, Chronic Kidney Disease
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
Enrolling by invitation
TimelyCare - A Proactive Primary Care Model: Delivering the Right Care at the Right Time for Individuals at Risk of High Care Consumption
Multimorbidity, Integrated Care
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
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.
Beth A Kozel, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Health Conditions and Older Age is Associated With Increased Pathogenicity, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site 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 1 inclusion and 1 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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). 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 20 Jan 2023.