Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04564274 |
| Other study ID # |
10000091 |
| Secondary ID |
000091-H |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 4, 2020 |
| Est. completion date |
May 20, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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....
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.
