Skip to main content
OpenTrials
Completed

NCT Number: NCT04363268

ACCESS A Master Digital Surveillance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronavirus COVID COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infection Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medable Inc.

Palo Alto, California, 94301, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Able to provide electronic informed consent
  • US Resident
  • Read and comprehend English

Exclusion criteria

  • Do not have a personal smartphone

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medable Inc.

Other

Collaborators

  • American Heart Association
  • BioIntelliSense
  • Datavant
  • PWNHealth

Registry information

Official study title

ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19

Acronym: ACCESS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2020
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.