Introducing CURE-19, a platform for at-home COVID-19 clinical trials
May 5, 2020

Curebase is announcing the launch of CURE-19, a dedicated platform for running at-home COVID-19 clinical trials. Via CURE-19, any patient in the United States, no matter where they live, can sign up for the platform and start participating in our studies right at home. There is no travel needed, and patients can be part of driving scientific discoveries, get free genomic and microbiome testing, and even get paid for their participation.

The system is made possible by Curebase, a decentralized CRO and software platform with patient-centric capabilities like telemedicine, mobile phlebotomy, remote informed consent, connecting electronic health records, and integrating data from smart devices. Visit CURE-19 At The Website→

The Impact

At-home clinical trials are more important now than ever because they:

  • Reach patients everywhere, not just near academic research centers
  • Are affordable and incredibly fast
  • Produce realistic data that includes real-world context
  • Keep patients at home and prevent the spread of the virus

Our at-home trials are so affordable, actually, that we are running clinical trials for free for any company or researcher that will make their data publicly available. For any non-profit initiatives that run on CURE-19, we are de-identifying and combining the data to create a truly novel dataset that has the full story of the patient and is available to the public for analysis.

Our dataset also combines multi-omics sequencing output with real-world context like hospitalizations, medical history, and COVID-19 outcomes. Any researcher may analyze the results and make discoveries that can improve our understanding of the disease.


A Coalition of Non-Profit Research Sponsors

CURE-19 is launching with three leading diagnostics startups and a leading digital therapeutics startup, each sponsoring a non-profit study on the platform for public benefit. The data from each of these studies will be de-identified and integrated into a first-of-its-kind dataset to enable the discovery of critical new biomarkers in the fight against COVID-19.

Sano Genetics

About the company: Sano Genetics a precision medicine research company that puts people at the center.

The Sano platform matches individuals research that is relevant for them, provides personalized feedback based on their data, and gives them full control of their data. The company also offers at-home DNA test kits that, combined with the software platform, enable fully virtual precision medicine research studies.

About the study: COVID-19 positive patients get a free genetic test.

https://sanogenetics.com/land/COVID-19

Persephone Biosciences

About the company: Combines AI with population-scale patient data to develop ground-breaking microbial cell therapies.

About the study: COVID-19 positive patients donate stool to explore the human gut microbiome for COVID-19 biomarkers.

https://persephonebiome.com/

DiscernDx

About the company: Making  regular health monitoring, early disease detection, and personalized care a reality for every individual.

About the study: Patients share a blood sample for free proteomics and metabolomics analysis.

https://discerndx.com/

Closed Loop Medicine

About the company: CLM is developing personalized care packages that integrate different treatment modalities to treat some of the biggest challenges facing global health systems today including sleep disorders, hypertension and  chronic pain.

About the study:Healthy patients and COVID-19 positive with high blood pressure receive a stipend for continuous blood pressure monitoring at home through the Closed Loop app.

https://www.closedloopmedicine.com/

How CURE-19 Fits in the COVID Landscape

CURE-19 fills an unmet need for operating at-home clinical research of COVID-19 patients. There are certain other digital direct-to-patient solutions, such as symptom trackers and clinical trial matchmakers that, but CURE-19 was needed for the following reasons.

Reason #1: Creating a rich, prospective dataset

There are a number of symptom tracking apps out there, but most clinical studies need significantly more depth of data to produce meaningful analyses.

CURE-19 asks patients to track symptoms, but that is just the start of the process. Patients also connect a medical record and smart devices. We know when patients test positive, are hospitalized, and recovered with original source data. And our partners are enabling at-cost testing of genomics, proteomics, metabolomics, microbiome, and continuous blood pressure monitoring to create a detailed picture of every patient.

Reason #2: We bring clinical trials directly to patients

There are some clinical trial matchmaking apps that allow patients to find trials for which they are eligible. This is a valuable service, but it still requires patients to live near a hospital and go in for their study visits. This leaves most patients out of  research due to geography, and unnecessarily risks spreading the virus if we bring healthy, mildly symptomatic, or recovered patients in for study visits.

CURE-19 is fully operating rigorous clinical trials and bringing them directly to patients, at home. Our studies are conducted online using techniques like telemedicine, data integrations, patient self-report, direct to patient supply shipment, patient reimbursement. Curebase, the platform powering CURE-19, has experience in FDA-grade direct-to-patient clinical trials and runs its own CRO.

Reason #3: This is FDA-grade clinical research data

Curebase has been running FDA-grade, remotely-managed clinical trials for a long time — we started doing this years before COVID-19 struck. So CURE-19 is built on top of the battle-tested Curebase clinical research platform, and the data we produce can be used for highly regulated purposes. We also have rigorous processes for managing quality and for ensuring that patient privacy is respected in the utmost.

Some more details that put us above other direct-to-patient data collection:

  • 21 C.F.R. Part 11 compliance
  • HIPAA compliance
  • Standardized drug coding
  • Auditability
  • Remote monitoring capability
  • GCP-compliant informed consent

Our Software Partners

CURE-19 is a non-profit initiative, and depends on the generous support from world-class cloud software products providing pro bono access to make this possible.

Human API

About the company: The easiest way for consumers to connect & share health data with the companies they trust.

https://www.humanapi.co/

1upHealth

About the company: Access 280 million patients from over 10,0000 health facilities using the 1upHealth award winning FHIR API platform. Receive patient authorized medical records in clean, consistent FHIR format.

https://1up.health/

DrugBank

About the company: DrugBank is a curated pharmaceutical knowledge base that is enabling major advances across the data-driven medicine industry that save lives and improve care. It includes clinical-level information about drugs such as side effects, drug interactions, as well as molecular level data such as chemical structures, how a drug is broken down in someone’s body (metabolism), and what proteins a drug interacts with.

https://www.drugbankplus.com/

How do patients get involved?

Any adult patient, sick or healthy, can join CURE-19! By connecting health records and smart devices, and tracking symptoms just once a week, patients can join the pool of individuals eligible for any new trials that join the platform.

Testing labs, physician clinics, and hospitals can also get involved. Referring your patients to CURE-19 is as simple as sending them to cure19.org to sign up and unlock clinical research opportunities from home.

What comes next for CURE-19?

We want more and more researchers to use CURE-19 to run affordable, representative, at-home research of COVID-19 patients. As the next wave of diagnostics, drug treatments, and vaccines become available, at-home research should be one of the first options under consideration. This is especially important for treatments that prevent patients from being hospitalized in the first place, and diagnostics that target healthy or recovered patients, such as antibody tests.

And again, any non-profit researchers can run trials at no cost with CURE-19. We are making all data operated by non-profit initiatives publicly available for the benefit of the public to fight COVID-19 and make meaningful discoveries.

Join us and help stop COVID-19 with patient-powered research, right from home!


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