June 19, 2020 | Platform trials may speed our race to COVID-19 treatments, argue some researchers. Other researchers are working on ways to make patients feel more connected and less frightened at home. Plus more from this week’s COVID-19 news and research in the clinical research industry.   

Research Updates 

Authors from University of Washington and Fred Hutchinson Cancer Research Center propose platform trials with outcome-adaptive randomization to efficiently select the most effective coronavirus disease 2019 (COVID-19) treatments in an opinion piece published in the Annals of Internal Medicine. Platform trials are large trials engaged in simultaneous testing of multiple treatment strategies in separate groups, with plans to discontinue any group that is definitively inferior at planned interim analyses. The authors also suggest that clinical trials make broader use of outcome-adaptive randomization, a specific adaptive design feature that potentially reduces the number of deaths or other adverse outcomes incurred during a trial. DOI: 10.7326/M20-2933 

Northwestern University wanted COVID-19 patients to feel cared about and less frightened while convalescing at home, so the hospital mounted a massive, daily home-monitoring program of patients presumed positive for COVID-19 with the assistance of nurses, nurse practitioners, a large workforce of medical students, physicians' assistants and daily questionnaires delivered through the Electronic Health Record portal. 7,604 patients monitored, of whom about 500 were sent to the emergency department. The development of the program, its feasibility and early results are published in New England Journal of Medicine Catalyst. DOI: 10.1056/cat.20.0214 

Researchers from Xi'an Jiaotong University, China, have published new insights into the clinical and epidemiological characteristics of pediatric patients with COVID-19 in PLOS Medicine. Relatively little is known about the clinical and epidemiological characteristics of pediatric patients. The researchers collected and analyzed the clinical data of 34 pediatric COVID-19 patients in four hospitals in China from January 27 to February 23. Patients presented with mild (18%) or moderate (82%) forms of COVID-19, and the most common initial symptoms were fever (76%) and cough (62%), which recovered within three or four days after treatment. In contrast to observations in adult patients, pediatric cases showed a higher proportion of fever, vomiting (12%), and diarrhea (12%) on admission. Chest computed tomographic (CT) scans revealed high-density patchy shadows with a late-onset pattern in lung-lobule lesions in 28 patients (82%). By contrast, only 3% of pediatric patients showed features called ground-glass opacities--hazy opacities that do not obscure the underlying bronchial structures or pulmonary vessels--which are typically seen in adults with COVID-19. The clinical presentations were not as severe as the signs observed in the CT images, and the recovery of lesions in lobules lagged behind that of the main symptoms. DOI: 10.1371/journal.pmed.1003130 

Humanigen has published data on the first clinical use of lenzilumab, a monoclonal antibody, in 12 COVID-19 patients. The manuscript was published online at medRxiv. Patients showed rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days and 100% survival to the data cut-off date. Patients also demonstrated rapid improvement in oxygenation, temperature, inflammatory cytokines and key hematological parameters consistent with improved clinical outcomes. DOI: 10.1101/2020.06.08.20125369 

Cleveland Clinic researchers have developed a prediction model for healthcare providers to forecast an individual patient's likelihood of testing positive for COVID-19 as well as their outcomes from the disease. According a new study published in CHEST, the risk prediction model (called a nomogram) shows the relevance of age, race, gender, socioeconomic status, vaccination history and current medications in COVID-19 risk. The risk calculator is a new tool for healthcare providers to aid them in predicting patient risk and tailoring decision-making about care. DOI: 10.1016/j.chest.2020.05.580 

Company Updates 

Two new trials at The Ohio State University are launching to test the impact of low-dose, whole lung radiation in the form of X-rays on patients who have acute respiratory distress syndrome (ARDS) as a result of COVID-19 infection. Decades of science have shown that low-dose radiation can elicit an anti-inflammatory immune response from the immune system. The first trial, PREVENT, is a national trial for COVID-19+ pneumonic patients who do not yet require mechanical breathing intervention (ventilator) but are experiencing severe respiratory distress. The study will involve up to 20 hospitals across the United States. The second trial, VENTED, is for patients who are critically ill and on a ventilator. This study will be conducted exclusively at Ohio State. Treatments will be administered in a COVID-19-only containment area and with a single machine not used for standard oncology care. Press release.  

Codagenix successfully synthesized a readily-scalable live-attenuated vaccine candidate against COVID-19. The vaccine, CDX-005, is currently undergoing safety and efficacy studies in animals and appears markedly attenuated compared to wild-type SARS-CoV-2, the virus that causes COVID-19, with pre-clinical data expected by early July. Codagenix, backed by investors Adjuvant Capital and TopSpin Partners, is collaborating with the Serum Institute of India to develop CDX-005. Although there are more than 140 COVID-19 vaccine candidates currently under development, CDX-005 is one of only a handful of live-attenuated approaches to tackling the current pandemic. Press release.  

PRA Health Sciences is enhancing its commercial Health Harmony COVID-19 Monitoring Program with the integration of the Microsoft Healthcare Bot service. Through a series of conversational questions and interactions within PRA’s Health Harmony digital health platform, the COVID-19 chatbot compares users’ symptoms to U.S. Centers for Disease Control guidance and then recommends one of three available COVID-19 programs in which they should enroll. For users of the Health Harmony app, the enrollment experience becomes more personalized and is more accurate in determining the level of COVID-19 care needed. For organizations that have implemented PRA’s COVID-19 Monitoring Program, the integration allows them to understand patient flow and to monitor, educate and individualize care with greater agility. Press release.  

Moderna expects to launch a phase 3 clinical study trial to test the efficacy of a COVID-19 vaccine on July 9. The National Institute of Allergy and Infectious Disease is administering the trail. The University of Illinois at Chicago has announced that it is among the sites. Press release.