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
|Condition or disease|
|Coronavirus COVID COVID-19 COVID19 Corona Virus Infection Coronavirus Infection|
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|
|Estimated Enrollment :||1000000 participants|
|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|
- 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.
- 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.
- Effect of medications on symptoms of COVID19 [ Time Frame: Up to 10 years ]To specifically identify medications and regimens that address disease symptoms
- 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.
- Rate of COVID19 infection and disease outcomes [ Time Frame: Up to 10 years ]To identify regional variations in disease incidence and outcomes.
- 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.
- 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.
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
|Contact: Reem Yunis, PhDfirstname.lastname@example.org|
|Contact: Jena Daniels, BSemail@example.com|
|United States, California|
|Palo Alto, California, United States, 94301|
|Contact: Reem Yunis, Ph.D. 877-820-6259 firstname.lastname@example.org|
|Contact: Jena Daniels, B.S. email@example.com|
|Principal Investigator: Ingrid Oakley-Girvan, Ph.D.|
|Sub-Investigator: Michelle Longmire, M.D.|
|Principal Investigator:||Ingrid Oakley-Girvan, PhD||Medable Inc.|