COVID-19JUPITERNCT04337762
Beat COVID-19 - Observational Trial
An observational study of COVID-19, run by Beat COVID LLC at 1 site in United States.
Trial summary
JUPITER is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of COVID-19 and understand factors that help reduce disease progression in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- COVID-19
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2020to Jul 2021
- 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 18 to 110 years
- All sexes
- Adult, Older adult
Study population: English Speaking adults aged 18 years or older with an ability to self-report their medical history and provide regular updates via an electronic data capture web portal that can be accessed through internet connection. Observational period for this trial will be 30 days involving regular updates from participants for the duration. Participants will also be asked whether they wish to be informed about additional opportunities/future studies pertaining to COVID-19.
Who may be able to join
- Adults residing in the United States aged 18 years or older proficient in understanding and reading the English language who wish to participate in the fight against COVID-19 by providing self-reported health information.
- Ability to complete electronic informed consent process.
- Ability to use the internet and check email regularly.
- Consent to provide a HIPAA waiver of health information to share protected health information.
Who cannot join
- 1. Inability to provide regular updates to their health status when contacted by the BEAT COVID study personnel via email or SMS.
Trial locations and contacts
1 site in 1 country.
Hollis Ledbetter contact
United States1 site, 1 recruiting
- Recruiting
Beat COIVD, LLC
Chicago, Illinois, 60452
About this study
Official title: A Virtual Observational Protocol to Gain Longitudinal Data in Participants to Help Understand COVID-19 Spread and Disease Progression
JUPITER is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of COVID-19 and understand factors that help reduce disease progression in patients with COVID-19. We aim to accomplish this by obtaining self-reported historical and longitudinal data from study participants.
Read the detailed description
This is an observational study that will electronically collect self-reported participant data in a database that follows HIPAA security requirements for those with a clinically confirmed case of COVID-19 or those who have had exposure to COVID-19.
The aim of this study is to gather a large, diverse dataset from a large population of participants in order to gather longitudinal observational data on what health practices participants are practicing and what, if any, benefits these practices may be providing the participants.
Data for this study will be gathered via self-reporting from participants who wish to participate in the fight against COVID-19. This will include getting a baseline of each participant's health and then monitor their health over time while looking at how their symptoms are progressing or regressing. The JUPITER study may also seek historical data from patients who have recovered from COVID-19.
The JUPITER dataset may be shared (in accordance with applicable state, federal, and local laws) so that others may utilize the data from the dataset for further analysis to determine relevant trends in the data and in turn hopefully use these trends to determine potential treatment protocols or lifestyle recommendations to help prevent COVID-19 spread and reduce hospitalization rates, as well as to understand how certain factors may aide in the COVID-19 disease progression.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| Healthy | Healthy adult individuals residing in the United States with no history of COVID-19 | |
| COVID-19 Confirmed | United States adults that have tested positive for SARS-CoV-2 virus which causes the human disease COVID-19 (IE novel coronavirus) or those that have been exposed to a confirmed case and are awaiting testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Outcomes
Patterns of data will be mined to understand risks for hospitalization and disease progression associated with COVID-19
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start6 Apr 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beat COVID LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337762
- Sponsor's protocol ID
- 20200835
- Acronym
- JUPITER
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Observational Protocol to Gain Longitudinal Data in Participants to Help Understand COVID-19 Spread and Disease Progression
- ClinicalTrials.gov ID
- NCT04337762
- Acronym / sponsor ID
- JUPITER / 20200835
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Beat COVID LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 Apr 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.
JUPITER is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of COVID-19 and understand factors that help reduce disease progression in patients with COVID-19. We aim to accomplish this by obtaining self-reported historical and longitudinal data from study participants.
Detailed description
This is an observational study that will electronically collect self-reported participant data in a database that follows HIPAA security requirements for those with a clinically confirmed case of COVID-19 or those who have had exposure to COVID-19.
The aim of this study is to gather a large, diverse dataset from a large population of participants in order to gather longitudinal observational data on what health practices participants are practicing and what, if any, benefits these practices may be providing the participants.
Data for this study will be gathered via self-reporting from participants who wish to participate in the fight against COVID-19. This will include getting a baseline of each participant's health and then monitor their health over time while looking at how their symptoms are progressing or regressing. The JUPITER study may also seek historical data from patients who have recovered from COVID-19.
The JUPITER dataset may be shared (in accordance with applicable state, federal, and local laws) so that others may utilize the data from the dataset for further analysis to determine relevant trends in the data and in turn hopefully use these trends to determine potential treatment protocols or lifestyle recommendations to help prevent COVID-19 spread and reduce hospitalization rates, as well as to understand how certain factors may aide in the COVID-19 disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy adult individuals residing in the United States with no history of COVID-19 |
| COVID-19 Confirmed | – | –United States adults that have tested positive for SARS-CoV-2 virus which causes the human disease COVID-19 (IE novel coronavirus) or those that have been exposed to a confirmed case and are awaiting testing |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- English Speaking adults aged 18 years or older with an ability to self-report their medical history and provide regular updates via an electronic data capture web portal that can be accessed through internet connection. Observational period for this trial will be 30 days involving regular updates from participants for the duration. Participants will also be asked whether they wish to be informed about additional opportunities/future studies pertaining to COVID-19.
Key inclusion criteria (4 listed)
- Adults residing in the United States aged 18 years or older proficient in understanding and reading the English language who wish to participate in the fight against COVID-19 by providing self-reported health information.
- Ability to complete electronic informed consent process.
- Ability to use the internet and check email regularly.
- Consent to provide a HIPAA waiver of health information to share protected health information.
Key exclusion criteria (1 listed)
- 1. Inability to provide regular updates to their health status when contacted by the BEAT COVID study personnel via email or SMS.
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
Health Outcomes
Time frame: 1 year
Patterns of data will be mined to understand risks for hospitalization and disease progression associated with COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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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.
Hollis Ledbetter contact
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 COVID-19, run by Beat COVID LLC 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 4 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rama Jager, M.D. ((708) 620-4608, rjager@beatcovidtrial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Outcomes (time frame: 1 year). 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 9 Apr 2020.