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ACCESS A Master Digital Surveillance Protocol for COVID-19 (ACCESS)

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: NCT04363268
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
Datavant
American Heart Association
BioIntelliSense
PWNHealth
Information provided by (Responsible Party):
Medable Inc.

Brief 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, 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.

Condition or disease
Coronavirus COVID COVID-19 COVID19 Corona Virus Infection Coronavirus Infection

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.

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Study Type : Observational
Estimated Enrollment : 1000000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : April 20, 2030
Estimated Study Completion Date : October 1, 2031

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Effect of medications on symptoms of COVID19 [ Time Frame: Up to 10 years ]
    To specifically identify medications and regimens that address disease symptoms

  4. 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.


Secondary Outcome Measures :
  1. Rate of COVID19 infection and disease outcomes [ Time Frame: Up to 10 years ]
    To identify regional variations in disease incidence and outcomes.

  2. Effect of COVID19 on health outcomes [ Time Frame: Up to 10 years ]
    To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.

  3. Long-term follow up and recontact [ Time Frame: Up to 10 years ]
    To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This is a national surveillance study for the general public.
Criteria

Inclusion Criteria:

  1. Aged 18 years or older
  2. Able to provide electronic informed consent
  3. US Resident
  4. Read and comprehend English

Exclusion Criteria:

1. Do not have a personal smartphone


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): NCT04363268


Contacts
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Contact: Reem Yunis, PhD 1-877-820-6259 reem.yunis@medable.com
Contact: Jena Daniels, BS 1-877-820-6259 jena@medable.com

Locations
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United States, California
Medable Inc. Recruiting
Palo Alto, California, United States, 94301
Contact: Reem Yunis, Ph.D.    877-820-6259    reem.yunis@medable.com   
Contact: Jena Daniels, B.S.       jena@medable.com   
Principal Investigator: Ingrid Oakley-Girvan, Ph.D.         
Sub-Investigator: Michelle Longmire, M.D.         
Sponsors and Collaborators
Medable Inc.
Datavant
American Heart Association
BioIntelliSense
PWNHealth
Investigators
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Principal Investigator: Ingrid Oakley-Girvan, PhD Medable Inc.
Additional Information:
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Responsible Party: Medable Inc.
ClinicalTrials.gov Identifier: NCT04363268    
Other Study ID Numbers: Pro00041635
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medable Inc.:
COVID
COVID-19
Corona
Coronavirus
COVID19
Coronavirus Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases