Clinical trial NCT04363268: ACCESS A Master Digital Surveillance Protocol for COVID-19
Official title: ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
COVID
COVID-19
COVID19
Corona Virus Infection
Coronavirus Infection
Keywords: COVID
COVID-19
Corona
Coronavirus
COVID19
Coronavirus Infection
Lead sponsor: Medable Inc.
Sponsor class: OTHER
Collaborators: name: Datavant
name: American Heart Association
name: BioIntelliSense
name: PWNHealth
First posted: 2020-04-27
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a national surveillance study for the general public.

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.

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

Primary outcomes:
measure: Development of population-based models of disease risk
timeFrame: Up to 10 years
measure: Relation between disease burden and geolocation
timeFrame: Up to 10 years
measure: Effect of medications on symptoms of COVID19
timeFrame: Up to 10 years
measure: Effect of medications on disease severity of COVID19
timeFrame: Up to 10 years
Secondary outcomes:
measure: Rate of COVID19 infection and disease outcomes
timeFrame: Up to 10 years
measure: Effect of COVID19 on health outcomes
timeFrame: Up to 10 years
measure: Long-term follow up and recontact
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Medable Inc.
state: California
Study officials:
affiliation: Medable Inc.
name: Ingrid Oakley-Girvan, PhD
role: PRINCIPAL_INVESTIGATOR
References: