April 10, 2020 | Coronavirus research, tools and offerings are advancing at a breakneck pace. The SARS-CoV-2 virus is serving as a rallying cry across the clinical research landscape inspiring creative new solutions, partnerships, and ideas to address the outbreak, treat and prevent the disease it causes, and address the life adjustments of our new normal. Here are some of the free tools, new solutions, and research this week.

Industry News

The National Institutes of Health has launched a clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has begun, with the first participants now enrolled in Tennessee.The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The first participants have enrolled in the trial at Vanderbilt University Medical Center, Nashville, one of dozens of centers in the PETAL Network. The blinded, placebo-controlled randomized clinical trial aims to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization. All participants in the study will continue to receive clinical care as indicated for their condition.  Those randomized to the experimental intervention will also receive hydroxychloroquine. Press release.

With support from Amazon Web Services, healthcare providers at the UC San Diego Health are using artificial intelligence (AI) in a clinical research study aimed at speeding the detection of pneumonia, a condition associated with severe COVID-19. The AI capability has so far provided physicians with unique insights into more than 2,000 images and, while still investigational, is affecting the clinical management of patients. Press release.

PatientSource will be offering an adapted version of its Electronic Patient Record (EPR) software to healthcare organizations across the globe, free of charge with minimal cloud hosting costs, to help combat the Coronavirus pandemic. The offering is a “slimmed down” version of its software, which can be installed and ready to go within as little as an hour. PatientSource offers a cloud-based interoperable patient record system with an intuitive interface, designed for use on the frontline of care. The clinician-designed solution works cross-platform on any device with a web browser: desktops, laptops, tablets and smartphones. The adapted version of the PatientSource software will feature a cloud-based electronic observation module complete with patient trackers and ward whiteboard tools that are attuned to COVID-19 patients and will be able to quickly identify the most critical, frail or deteriorating patients in a challenging setting. More information.

MyDoc, a UST Global portfolio company, is partnering with First Medicine Corporation to provide free access to the telemedicine solution for the next 90 days in the United States. MyDoc will help conduct early triage and redirect patients to virtual care clinics for COVID-19 as well as non-COVID conditions as the “de facto” to reduce the overall demand on the healthcare system. MyDoc’s fully integrated online-to-offline platform streamlines all aspects of primary healthcare into one easy-to-use solution connecting patients to doctors, pharmacies, diagnostic laboratories, clinical-grade health trackers, Fortune 500 and SME employers, and insurers. First Medicine Corporation is an online healthcare teleconsultation service designed to support people as they deal with the questions and challenges of the current COVID-19 pandemic among other health concerns.  Its founders represent early leaders in the field of telemedicine and were responsible for the growth of NightHawk Radiology, one of the first major telemedicine IPOs in the healthcare industry. Press release. 

LabCorp and Ciox Health are collaborating on a comprehensive U.S.-based COVID-19 patient data registry. This registry will house curated, HIPAA-compliant de-identified data sets to expedite clinical research and analyses related to COVID-19. This patient data registry is expected to enable researchers to better understand and characterize COVID-19 diagnoses and treatments and generate insights that will aid ongoing and future pandemic preparedness and prevention efforts. LabCorp has performed approximately 500,000 tests since first making its COVID-19 test available March 5. The registry will leverage LabCorp’s deep scientific and research expertise and the unique, rapidly expanding de-identified datasets from its COVID-19 testing platform. To yield a more complete view of clinical paths and outcomes, this dataset will be supplemented with additional longitudinal medical record data, compiled using the Ciox Health DataFit Platform. The data sets will be compliantly and safely aggregated to rapidly construct research-grade clinical cohorts for a wide range of epidemiological, clinical and observational uses. Press release. 

GetWellNetwork has responded to COVID-19 developments by constructing a Readiness Center on its website to help medical facilities, patients and families better navigate uncertain times with existing and newly-developed digital tools. In addition to tools, the new web pages offer solutions to scaling information sharing, guiding patients, and easing the burden for care teams. More information.

The Consortium of Multiple Sclerosis Centers and the National Multiple Sclerosis Society have created a new North American database, coined COViMS, to capture COVID-19 infections and outcomes in people with MS and related diseases. No such reporting system previously existed. The goal of the COViMS registry is to rapidly define the impact of COVID-19 on patients with MS and how factors such as age, comorbidities and MS treatments impact COVID outcomes. Case report forms are available to providers on the COViMS website.

Greenphire has launched its ConneX Patient Direct service to enable global clinical trial sites to continue their critical work and patient support in an effort to offset the impact of COVID-19. The new service is an extension of Greenphire's ConneX concierge travel solution for clinical trials, and provides "clean transport" for medications, equipment and healthcare professionals to visit patients in their homes. Press release.

With funding from the Bill & Melinda Gates Foundation, Certara has launched the COVID-19 Pharmacology Resource Center to help advance therapeutics for COVID-19. The Center is an online resource that unites experts across the globe in accelerating efforts in the fight against COVID-19 by providing pharmacology simulation tools and a forum for scientific exchange. The Center emphasizes the importance of incorporating clinical pharmacology and translational medicine principles to optimize dosing in clinical studies. The Center is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir. The Center features computer simulation tools that are updated with emerging data and include patient factors such as body mass index and lung tissue concentration. Using these tools to help determine the optimal dose will lead to faster, more efficient clinical trials in the search for COVID-19 therapies. The Center also provides a platform to facilitate the exchange of current and emerging information to help design well-controlled clinical trials. Press release.

Symphony Health, a PRA Health Sciences company, will make a 30-day license of its newly released Metys COVID-19 Module available to the U.S. life science industry at no charge. The COVID-19 Module within the Metys platform will provide up to three users per company with access to all drugs and markets within any U.S. geographic region down to CBSA (core-based statistical area). The module will include history back to October 2018 to ensure access to comparative flu season trends in prior years, with March 2020 data becoming available on April 10. Companies may publish or report insights or findings from the data with prior permission from Symphony. Press release.

Mount Sinai Health System has launched a web-based app to capture the symptoms and spread of COVID-19 across New York City—currently the epicenter of largest outbreak in the U.S. A team of data scientists, physicians, and engineers are seeking citywide enrollment with the tool. Users are asked to complete an initial survey with questions about demographics, exposure, and symptom history, and thereafter short daily surveys about their symptoms through text messages sent to their phones. Results could guide long-term research about factors affecting the spread of the virus and jumpstart enrollment for future clinical trials and studies for treatments. Press release.

The West Virginia University Rockefeller Neuroscience Institute, WVU Medicine, and smart ring maker Oura Health have launched a study that aims to predict outbreaks of COVID-19 in healthcare professionals before they become symptomatic. It is taking a “digital PPE” approach by leveraging an AI-driven predictive model, wearable ring technology and a COVID-19 monitoring app. Researchers will holistically monitor more than 1,000 frontline healthcare workers in hospitals around the country, integrating physiological measures with psychological, cognitive and behavioral biometrics in real time. They’re working toward a three-plus day forecast. News release.

Latest from the Literature

The chief scientist of the Biogerontology Research Foundation (also CEO of artificial intelligence company Insilico Medicine) proposes that SARS-CoV-2 be called a gerophilic and gerolavic infection since it is more infectious and harmful to the elderly. The strategy, outlined in the journal Aging, calls for repurposing known geroprotectors for the prevention of coronavirus. An additional proposal is to use inexpensive and minimally invasive deep aging clocks to track the efficacy of preventive geroprotective interventions and to stratify the patients by predicted severity of COVID-19. DOI:10.18632/aging.102988

A team of physician-scientists at Beth Israel Deaconess Medical Center are now enrolling patients in a clinical trial to evaluate tPA for the treatment of COVID-19-positive patients with acute respiratory distress syndrome (ARDS). The trial’s launch follows a special report the team published in the Journal of Trauma and Acute Care Surgery suggesting the common anti-clotting drug be used to reduce deaths among patients experiencing the complication. DOI: 10.1097/TA.0000000000002694

Common surgical masks are fine for most healthcare workers involved in COVID-19 treatment, according to preliminary research from McMaster University. N95 respirator masks should be preserved for those inserting breathing tubes. A systematic review of four randomized controlled trials conducted since 1990, which has been accepted for publication in Influenza and Other Respiratory Viruses, suggests the use of medical masks doesn’t increase viral respiratory infection or clinical respiratory illness. DOI:10.1111/irv.12745

A new antiviral drug, called EIDD-2801—heads into clinical trials and scientists are hopeful that it will change the way doctors treat COVID-19. Researchers at the UNC-Chapel Hill Gillings School of Global Public Health are playing a key role in its development and testing, working with colleagues at Vanderbilt University Medical Center and the Emory Institute for Drug Development (EIDD) where EIDD-2801 was discovered. Results of the team's most recent study were recently published by Science Translational Medicine. DOI:10.1126/scitranslmed.abb5883 

Environmental scientists from Aarhus University in Denmark and health researchers from the University of Siena in Italy have demonstrated a probable correlation between air pollution and coronavirus mortality in two of the worst affected regions in northern Italy. The mortality rate is up to 12% in the northern part of Italy, versus about 4.5% in the rest of the country. The journal Scientific Pollution published their study, which used data from the NASA Aura satellite and compared it to the Air Quality Index developed by the European Environment Agency. DOI:10.1016/j.envpol.2020.114465

Smokers and people with chronic obstructive pulmonary disease may have higher levels of a coronavirus “entry point” enzyme in their lungs and thus be at heightened risk of severe COVID-19, according to Canadian researchers at the University of British Columbia and St. Paul's Hospital in Vancouver.  They also found that former smokers had similar levels of the molecule, called angiotensin converting enzyme II or ACE-2, as people who had never smoked. Their study published in the European Respiratory Journal. DOI:10.1183/13993003.00688-2020