CoronavirusACCESSNCT04363268
ACCESS A Master Digital Surveillance Protocol for COVID-19
An observational study of Coronavirus and COVID, run by Medable Inc. at 1 site in United States.
Trial summary
ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, COVID, COVID-19
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 31 Dec 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 18 years and older
- All sexes
- Adult, Older adult
Study population: This is a national surveillance study for the general public.
Who may be able to join
- Aged 18 years or older
- Able to provide electronic informed consent
- US Resident
- Read and comprehend English
Who cannot join
- 1. Do not have a personal smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19
ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.
Read the detailed description
In the urgency of the COVID-19 outbreak, Medable will enable an observational study protocol under which clinical trials can rapidly be conducted. The observational study protocol will include the conduct of smartphone based research to capture an essential dataset to improve our understanding of disease evolution, risk factors, and outcomes as well as enable population-based monitoring to reduce the spread of disease. Under this protocol, sub-studies and clinical trials can be conducted for interventions, including vaccine trials. The work may include new tools such as surface environmental or personal swabs to test for presence or absence of disease. Data collection efforts on behalf of rapidly evolving multiple study designs and participant opt-in data sharing, will enable the compilation of critical epidemiological and other data across the United States to accelerate the understanding for effective mitigation and treatment of COVID-19.
ACCESS (American COVID-19 Collaborative Enabling Seamless Science), a novel COVID-19 digital research infrastructure, provides a mobile app tool for participants to report specific data and facilitate remote access to accelerate critical research and clinical treatment development.
ACCESS leverages leading digital health technologies to facilitate at-home research, clinical trials, and population-based long-term outcome studies and data de-identification measures (data coding/tokenization). The infrastructure combines opt-in wearable sensors, patient reported data and outcomes, opt-in data aggregation and additional opportunities for users to participate in clinical trials and share their de-identified data based upon reported information.
Prior to COVID-19, the FDA expressed an interest in expediting drug development through developing trial designs that test multiple drugs and/or multiple subpopulations in parallel under a single protocol, without a need to develop new protocols for every trial. This has become even more important during the COVID-19 pandemic. This type of work will also be enabled under the ACCESS system.
- Conditions
- Coronavirus, COVID, COVID-19, COVID19, Corona Virus Infection, Coronavirus Infection
- Keywords
- COVID, COVID-19, Corona, Coronavirus, COVID19, Coronavirus Infection
- Medical subject headings
- Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of population-based models of disease risk
To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.
Measured: Up to 10 years
Relation between disease burden and geolocation
To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.
Measured: Up to 10 years
Effect of medications on symptoms of COVID19
To specifically identify medications and regimens that address disease symptoms
Measured: Up to 10 years
Effect of medications on disease severity of COVID19
To specifically identify medications and regimens that treat and reduce disease severity.
Measured: Up to 10 years
Secondary outcomes (3)
Rate of COVID19 infection and disease outcomes
To identify regional variations in disease incidence and outcomes.
Measured: Up to 10 years
Effect of COVID19 on health outcomes
To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.
Measured: Up to 10 years
Long-term follow up and recontact
To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Apr 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medable Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Datavant, American Heart Association, BioIntelliSense, PWNHealth
- Responsible party
- Sponsor
- Investigators
- Ingrid Oakley-Girvan, PhD, Principal investigator, Medable Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363268
- Sponsor's protocol ID
- Pro00041635
- Acronym
- ACCESS
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Please reach out to the study team for data sharing policies and procedures. Only de-identified and aggregate data may be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19
- ClinicalTrials.gov ID
- NCT04363268
- Acronym / sponsor ID
- ACCESS / Pro00041635
- Conditions
- Coronavirus, COVID, COVID-19, COVID19, Corona Virus Infection, Coronavirus Infection
- Keywords
- COVID, COVID-19, Corona, Coronavirus, COVID19, Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Medable Inc.University, hospital or other
- Collaborators
- Datavant, American Heart Association, BioIntelliSense, PWNHealth
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 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.
ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.
Detailed description
In the urgency of the COVID-19 outbreak, Medable will enable an observational study protocol under which clinical trials can rapidly be conducted. The observational study protocol will include the conduct of smartphone based research to capture an essential dataset to improve our understanding of disease evolution, risk factors, and outcomes as well as enable population-based monitoring to reduce the spread of disease. Under this protocol, sub-studies and clinical trials can be conducted for interventions, including vaccine trials. The work may include new tools such as surface environmental or personal swabs to test for presence or absence of disease. Data collection efforts on behalf of rapidly evolving multiple study designs and participant opt-in data sharing, will enable the compilation of critical epidemiological and other data across the United States to accelerate the understanding for effective mitigation and treatment of COVID-19.
ACCESS (American COVID-19 Collaborative Enabling Seamless Science), a novel COVID-19 digital research infrastructure, provides a mobile app tool for participants to report specific data and facilitate remote access to accelerate critical research and clinical treatment development.
ACCESS leverages leading digital health technologies to facilitate at-home research, clinical trials, and population-based long-term outcome studies and data de-identification measures (data coding/tokenization). The infrastructure combines opt-in wearable sensors, patient reported data and outcomes, opt-in data aggregation and additional opportunities for users to participate in clinical trials and share their de-identified data based upon reported information.
Prior to COVID-19, the FDA expressed an interest in expediting drug development through developing trial designs that test multiple drugs and/or multiple subpopulations in parallel under a single protocol, without a need to develop new protocols for every trial. This has become even more important during the COVID-19 pandemic. This type of work will also be enabled under the ACCESS system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a national surveillance study for the general public.
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Able to provide electronic informed consent
- US Resident
- Read and comprehend English
Key exclusion criteria (1 listed)
- 1. Do not have a personal smartphone
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
Development of population-based models of disease risk
Time frame: Up to 10 years
To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.
Relation between disease burden and geolocation
Time frame: Up to 10 years
To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.
Effect of medications on symptoms of COVID19
Time frame: Up to 10 years
To specifically identify medications and regimens that address disease symptoms
Effect of medications on disease severity of COVID19
Time frame: Up to 10 years
To specifically identify medications and regimens that treat and reduce disease severity.
3 secondary outcomes
Rate of COVID19 infection and disease outcomes
Time frame: Up to 10 years
Effect of COVID19 on health outcomes
Time frame: Up to 10 years
Long-term follow up and recontact
Time frame: Up to 10 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 25 May 2023.
- Press Release of Collaborative Framework for ACCESSLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Please reach out to the study team for data sharing policies and procedures. Only de-identified and aggregate data may be considered for sharing.
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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.
Ingrid Oakley-Girvan, PhD principal investigator
Medable Inc.
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 Coronavirus and COVID, run by Medable Inc. 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: finished, as of the sponsor's last update on 25 May 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?
Development of population-based models of disease risk (time frame: Up to 10 years). The study lists 4 primary outcomes in all. 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 25 May 2023.