Your Coronavirus update for May 20; stay up to date with Elite.
More than 4.7 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including nearly 320,000 deaths. Healthcare officials in the United States have reported more than 1.5 million positive COVID-19 patients and more than 90,000 deaths.
Consortium Releases Osteoporosis Guidelines Amid Stay-At-Home Orders
With hospitals experiencing as much as an 80 percent decrease in patients seeking treatment of osteoporosis, some health experts are becoming anxious that needed treatment for the condition that affects millions of people per year in the United States.
According to a prepared statement released recently by the American Society for Bone and Mineral Research (ASBMR), abruptly stopping some drug therapies increases the risk of fractures, which can subsequently increase death risk.
In response to this a group of organizations, including the Society, the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation, has released guidelines to assist healthcare professionals who are treating patients with osteoporosis during this time.
Among the recommendations are:1
- A delay in treatment should be considered for patients taking Prolia® (denosumab). If the delay exceeds one month (that is, seven months from the most recent prior injection), a temporary transition to an oral bisphosphonate should be considered.
- A delay in treatment should be considered for patients taking Forteo® (teriparatide), Tymlos® (abaloparatide), or Evenity® (romosozumab). If the delay exceeds three months, a temporary transition to oral bisphosphonate should be considered.
- Delays of several months are unlikely to be harmful for patients who are taking an IV bisphosphonate.
The guidelines are said to help address the challenges that social distancing has presented for treating current osteoporosis patients. Guidance is also given on how some patients may be transitioned to alternative therapies until they are again able to resume their original treatment.
“The scale of the COVID-19 pandemic is unprecedented,” said incoming ASBMR president Suzanne Jan De Beur, MD, who serves as associate professor of medicine at Johns Hopkins University School of Medicine. “There is a paucity of data to provide clear guidance for healthcare professionals on how to adjust treatment for these patients to oral bisphosphonates. These recommendations and the supporting evidence provide a roadmap to clinicians and their patients.” Osteoporosis causes more than 8.9 million fractures annually around the globe, according to the ASBMR. “We are seeing an 80% decrease in osteoporosis treatment visits at our main MGH hospital,” said Elaine Yu, MD, MMSc, clinical researcher and endocrinologist at Massachusetts General Hospital (MGH) and Director of the MGH Bone Density Center and Assistant Professor in Medicine at Harvard Medical School. “We need to ensure that patients are able to safely stay on track with their treatments, and that we continue to do all that we can to reduce their risk for fracture.”
When possible, patients should continue on their prescribed osteoporosis regimens, the consortium members urge.
New Concerns Affecting Kidneys Emerge Among Coronavirus Patients
Among the growing list of impacts that the novel coronavirus is having on patients worldwide is a sudden spike in kidney-related symptoms. According to representatives from the American Nephrology Nurses Association, many patients who are diagnosed with the virus are experiencing severe, sudden acute kidney injury (AKI) with life-threatening hyperkalemia. The most recent evidence shows that this occurs 8-10 days after diagnosis. Patients are said to be having cytokine storms while kidney failure and hyperkalemia occur peri-intubation. Many of the critically ill patients have been placed on continuous renal replacement therapies and when transitioned to hemodialysis are too unstable and crash. Many of these patients are also said to be on at least one pressor for hypertension support. Another commonality among this cohort is that patients seem to have acute tubular necrosis. Biopsies are showing virus particles directly in the kidneys, which is proving that this virus is actively attacking the kidney cells, said Faith Lynch, MSN, RN. “This seems to occur in the more critically ill population with COVID-19,” she said. “Forty percent of these critically ill patients are having AKI. This is significantly higher than the usual 12-15 percent of patients who are critically ill with AKI in hospital intensive care units.”
FDA Green Lights Home Testing Kit
Officials with the U.S. Food & Drug Administration (FDA) have issued an emergency use authorization to for a COVID-19 home testing kit. The first standalone at-home sample collection kit, which can be used with certain authorized tests, is produced by Everlywell Inc., a company based in Austin, TX. The kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider, FDA officials said. This allows an individual to self-collect a nasal sample at home using the kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit.
Potential COVID Vaccine Produces Positive Results in Humans
Interim clinical data from a Phase 1 study on a vaccine candidate against the novel coronavirus COVID-19) led by the National Institute of Allergy and Infectious Diseases (NIAID) are said to be showing promise about the vaccine’s potential. According to officials with Moderna Inc., a clinical stage biotechnology company based in Cambridge, MA, immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Dose-dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.
At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts, officials said. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.
mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies, according to a report released may 18. The sole incidence of a Grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced Grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with Grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No Grade 4 adverse events or serious adverse events have been reported, officials said.
Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects initiation of a Phase 3 trial in July, subject to finalization of the clinical trial protocol, officials said. On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. On May 12, the FDA granted mRNA-1273 Fast Track designation.
Thank you for joining us for your coronavirus update for May 20. If you missed last week’s article, please consider reading it here.
Reference
1. Coalition of bone health experts issues joint guidance on osteoporosis management in the covid-19 era. ASBMR. 2020. Accessed online: www.asbmr.org/About/PressReleases/Detail.aspx?cid=512c6cf9-3514-456a-af4b-357e0e60acae
