ACCESS A Master Digital Surveillance Protocol for COVID-19

NCT ID: NCT04363268

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Datavant

INDUSTRY

Sponsor Role: collaborator

American Heart Association

OTHER

Sponsor Role: collaborator

BioIntelliSense

UNKNOWN

Sponsor Role: collaborator

PWNHealth

UNKNOWN

Sponsor Role: collaborator

Medable Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingrid Oakley-Girvan, PhD

Role: PRINCIPAL_INVESTIGATOR

Medable Inc.

Locations

Medable Inc.

Palo Alto, California, United States

Countries

United States

Related Links

https://www.biospace.com/article/releases/companies-launch-new-framework-to-accelerate-covid-19-research-streamlines-path-for-diagnostics-monitoring-and-clinical-trials/?TrackID

Press Release of Collaborative Framework for ACCESS

Other Identifiers

Pro00041635

Identifier Type: -

Identifier Source: org_study_id