Paris-based health care startup Cardiologs Technologies SAS has launched a clinical study to assess the use of its artificial intelligence (AI) platform to remotely monitor cardiac safety in COVID-19 patients being treated with the malaria drug hydroxychloroquine. The study, which will use electrocardiogram (ECG) data collected from smartwatches, could help to detect and prevent serious cardiac effects of the drug.

Hydroxychloroquine has long been used to treat patients with ailments like malaria, rheumatoid arthritis and lupus. Since the COVID-19 outbreak, President Trump has touted the drug’s “tremendous promise” as a potential treatment, and a number of hospitals are using it off-label as a front-line defense in patients hospitalized with the novel coronavirus.

The drug’s use comes with serious risks, however, including QT prolongation, an electrical disturbance in which the heart muscle takes longer than normal to recharge between beats. Visible on ECGs, QT prolongation can lead to severe heart arrhythmias and even death. Recent studies cast doubt on hydroxychloroquine’s overall benefit as a treatment for COVID-19, including a study funded by the National Institutes of Health and University of Virginia, which showed patients who took the drug had higher death rates than those who did not – underscoring the need for more information on potential side effects.

Reduces risk of ECG contamination

The Cardiologs study will enroll up to 100 patients at the University Hospital of Marseilles who are being treated with hydroxychloroquine and azithromycin, a combination that can increase the risk of QT prolongation.

Patients will be equipped with the Move ECG watch, manufactured by Withings SA, of Issy-les-Moulineax, France. Over the course of a 10-day treatment, patients’ ECG readings will be relayed to Cardiologs’ AI platform, where the data will be compared with the ECG, the gold standard for diagnosing rhythm disorders, and scrutinized for possible drug -induced cardiotoxicity and arrhythmias.

QT interval is typically assessed using ECG, the danger of transmitting COVID-19 and large number of hospitalized patients makes that both risky and impractical.

“The objective of our study is to evaluate a new method of QT measurement using Cardiologs’ AI-based solution and ECG data collected via smartphones,” said Jean-Claude Deharo, head of the cardiac arrhythmia department at University Hospital of Marseilles and the principal investigator in the study. “Smartwatches are already in the clinical setting but do not have validated QT analysis available. Combining these technologies will enable clinicians to overcome the practical limitations in the context of COVID-19 of the standard cardiac safety strategy that requires heavy patient interaction.”

FDA-cleared AI platform

Cardiologs’ FDA-cleared, cloud-based ECG analysis platform enables clinicians to use its AI-powered software to diagnose cardiac arrhythmias in a fraction of the time required to manually read and analyze a Holter monitor-generated ECG, which can take anywhere from 20 minutes up to several hours.

“QT analysis is already part of our offering,” Yann Fleureau, Cardiologs’ co-founder and CEO, told BioWorld. “We have internal performance data, but we do not have published performance. That will be a first.”

He added that the findings can be used to mitigate the benefit vs. risk of combined hydroxychloroquine and azithromycin therapy. “The QT prolongation side effects caused by hydroxychloroquine and many other drugs are detected using standard medical-grade ECGs, but with so many wearable ECG sensors out there in people’s home, and given current strain on health care resources, it makes sense to test whether a cloud-based AI system can be used instead to monitor cardiac safety remotely.”

More use cases, studies being explored

Given that a significant number of COVID-19 patients develop arrhythmias, Cardiologs is exploring other COVID-19-related use cases for its platform. The company, which opened an office in Boston last May, is also looking at additional studies with U.S. partners using different wearable ECG monitors. A number of smartwatches offer the feature, in addition to Move ECG, including Fitbit Drive, Apple Watch Series 5 and the Samsung Galaxy Watch Active 2.

Jag Singh, a cardiologist at Massachusetts General Hospital and professor medicine at Harvard Medical School who serves as a scientific advisor to Cardiologs, said the study could have implications for managing risk from drug-induced cardiotoxicity beyond the current COVID-19 context. “Personal ECG sensors could potentially find a role in the management of these patients, but also add value in other routine clinical care, since over 300 commonly used drugs may have similar QT prolongation risks as hydroxychloroquine.”

Cardiologs raised $15 million earlier this year in a series A round led by Alven Capital Partners. The funds were earmarked for commercialization and platform enhancements, including new integrations and applications. At the time, Fleureau said the company was focused in two directions: increasing automation of diagnostics through greater AI abilities and building predictive capabilities.

“The subject matter of that [current] study, enabling cardiac safety through wearable devices and AI, is … a potential new application of Cardiologs’ AI, which aligns directly with our broader mission: democratize expert cardiac care,” he said.

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