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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Coronavirus Infection; COVID; Corona Virus Infection; Coronavirus; COVID19

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 Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

• Study Contact: Name: Reem Yunis, PhD; Phone Number: 1-877-820-6259; Email: reem.yunis@medable.com
• Study Contact Backup: Name: Jena Daniels, BS; Phone Number: 1-877-820-6259; Email: jena@medable.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Medable Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This is a national surveillance study for the general public.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 10 years
Effect of medications on symptoms of COVID19	To specifically identify medications and regimens that address disease symptoms	Up to 10 years
Effect of medications on disease severity of COVID19	To specifically identify medications and regimens that treat and reduce disease severity.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of COVID19 infection and disease outcomes	To identify regional variations in disease incidence and outcomes.	Up to 10 years
Effect of COVID19 on health outcomes	To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.	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.	Up to 10 years

Collaborators and Investigators

• Sponsor: Medable Inc.
• Collaborators: American Heart Association; Datavant; BioIntelliSense; PWNHealth
• Investigators: Principal Investigator: Ingrid Oakley-Girvan, PhD, Medable Inc.

Publications and helpful links

Helpful Links

• Press Release of Collaborative Framework for ACCESS

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; COVID; COVID19; Coronavirus Infection; Corona
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: Pro00041635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No