February 19, 2021 | Europe’s vaccination priority for the mentally ill, fighting “vaccine nationalism”, how the humidity inside the face mask can help. Plus: trials of remdesivir in pregnant women, EMA releases guidance on trials during pandemic, and seeking priority vaccines for cancer patients, diabetes sufferers.

Research Updates

A survey by Europe's main psychiatric and mental health patient organizations summarizes European countries’ vaccine plans for the mentally ill. Eight of 20 countries explicitly mentioned psychiatry or mental illness in their national vaccine strategy documents. Several countries prioritized institutional residents, which can include people with severe mental illness. Only four countries (Denmark, Germany, the Netherlands, and the UK) had some form of higher vaccination priority for outpatients with severe mental illness. Additionally, Latvia, Romania, Spain, and Sweden prioritized outpatients with disabilities, possibly including severe mental illness, whereas the Czech Republic and Sweden specified behavioral or mental problems interfering with pandemic regulation adherence as priority indication. The data are published in Lancet Psychiatry. DOI: 10.1016/S2215-0366(21)00046-8

Italian researchers studied 381 COVID-19 patients who presented to the emergency department and later recovered to assess the impact of post-traumatic stress disorder on COVID-19 patients. PTSD was found in 115 patients. Additional diagnoses were depressive episode (66), hypomanic episode (3), generalized anxiety disorder (27), and psychotic disorders (1). Patients with PTSD were more frequently women, reported higher rates of history of psychiatric disorders, and delirium or agitation during acute illness. The published their findings in JAMA Psychiatry. DOI: 10.1001/jamapsychiatry.2021.0109

New research published in the European Heart Journal found that about 50% of patients who have been hospitalized with severe COVID-19 and who show raised levels of a protein called troponin have damage to their hearts. The injury was detected by magnetic resonance imaging (MRI) scans at least a month after discharge. 148 patients with severe COVID-19 were considered. 70% were male and the median age was 64 years old. Damage includes inflammation of the heart muscle (myocarditis), scarring or death of heart tissue (infarction), restricted blood supply to the heart (ischaemia) and combinations of all three. DOI: 10.1093/eurheartj/ehab075

Updated results from the CORONADO study analyzing the outcomes of patients with diabetes admitted to hospital with COVID-19, shows that one in five patients die within 28 days while around half are discharged. The study is published in Diabetologia (the journal of the European Association for the Study of Diabetes). Computer modelling revealed various factors such as younger age, routine diabetes therapy with the drug metformin, and longer symptom duration on admission were associated with a higher chance of discharge from hospital. DOI: 10.1007/s00125-020-05351-w

A University of Pennsylvania team published research in American Journal of Roentgenology on brain findings from COVID-19 patients. Among 2820 inpatients with coronavirus disease (COVID-19), 59 (2.1%) underwent brain MRI. Of them, six (10.2%) had MRI findings suspicious for COVID-19–related disseminated leukoencephalopathy (CRDL), which is characterized by extensive confluent or multifocal white matter lesions (with characteristics and locations atypical for other causes), microhemorrhages, diffusion restriction, and enhancement. CRDL is an uncommon but important differential consideration in patients with neurologic manifestations of COVID-19. The authors highlight several limitations of their work, but emphasize that leukoencephalopathy represents an uncommon, but important, differential consideration in patients with COVID-19 with neurologic manifestations. DOI: 10.2214/AJR.20.24364

Rich nations should not engage in "vaccine nationalism" and keep the COVID-19 vaccine to themselves when poorer nations need them, according to Nicole Hassoun, professor of philosophy at Binghamton University, State University of New York. Hassoun's paper, "Against Vaccine Nationalism," was published in the Journal of Medical Ethics. While rich countries like the US and UK are starting to vaccinate their populations against COVID-19, poor countries may lack access to a vaccine for years. Canada, for instance, has already secured enough to vaccinate its entire population nine times over, and the US, European Union, UK, Australia, and Japan can vaccinate their populations between 2-8x. Hassoun also pointed out that it's in rich countries' long-term interests to equitably distribute vaccines. DOI: 10.1136/medethics-2020-107193

Researchers at the University of Washington published updated numbers on SARS-CoV-2 infection rates in pregnant women based on pregnant patients diagnosed between March 1 and June 30, 2020. They found 240 infections among pregnant patients; 70.7% were from minority racial and ethnic groups. The SARS-CoV-2 infection rate in pregnant people was also 70% higher than similarly aged adults in Washington State, which could not be completely explained by universal screening at delivery. The authors argue that these data suggest that pregnant women should be broadly prioritized for COVID-19 vaccine allocation. They published their work in the American Journal of Obstetrics and Gynecology. DOI: 10.1016/j.ajog.2021.02.011

COVID-19 has been linked with eye abnormalities like conjunctivitis and retinopathy. A research team from the French Society of Neuroradiology (SFNR) looked at 129 patients with severe COVID-19 who underwent brain MRI. They found nine patients with abnormal MRI findings of the globe, or eyeball. All nine patients had nodules in the macular region, the area in the back of the eye responsible for our central vision. Eight had nodules in both eyes. The authors suggest that screening should be considered in all patients with severe COVID-19 to detect these nodules. “Screening of these patients might improve the management of potentially severe ophthalmological manifestations of the virus,” they write in their publication in Radiology. DOI: 10.1148/radiol.2021204394

While masks decrease the chance of spreading or getting COVID-19, NIH researchers now propose that the humidity created inside a face mask may help combat the symptoms of COVID-19, because hydration of the respiratory tract is known to benefit the immune system. “This mode of action suggests that masks can benefit the wearer even after an infection in the upper respiratory tract has occurred, complementing the traditional function of masks to limit person-to-person disease transmission,” they write. “This potential therapeutical use should be studied further.” The study published in the Biophysical Journal. DOI: 10.1016/j.bpj.2021.02.002

Industry Updates

A new study funded by the National Institutes of Health will evaluate the effects of remdesivir in pregnant women who have been prescribed the drug to treat COVID-19. The study, which will be conducted at 17 sites in the continental United States and Puerto Rico, aims to determine how pregnant women metabolize the drug and whether there are any potential side effects. The study is funded by NICHD, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Mental Health, all part of NIH. Called IMPAACT 2032, the study will be conducted by the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network. Press release.

Synairgen has begun dosing in the inhaled interferon beta formulation (SNG001) sub-study of the ACTIV-2 Phase II/III trial, evaluating patients with mild to moderate COVID-19 symptoms not yet requiring hospitalization. ACTIV is a public-private partnership to develop a coordinated research strategy to speed up the development of the most promising COVID-19 treatments and vaccines. ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG). Press release.

The European Medicines Association has released temporary guidance on the management of clinical trials during the COVID-19 pandemic. Extraordinary measures may need to be implemented and trials adjusted due to trial participants being in self-isolation/quarantine, limited access to hospitals, and health care professionals being committed to critical tasks, they write. Therefore they include guidance on initiating new trials, changing ongoing trials, safety reporting, risk assessment, changes in monitoring and auditing, protocol development, and more. Guidance PDF

130 organizations, cancer centers, and other institutions sent a letter to President Joseph R. Biden, key members of his administration, and leading public health officials at state health departments to underscore the importance of prioritizing patients with active cancer and survivors of cancer when administering the lifesaving COVID-19 vaccines. The broad spectrum of co-signatories to this letter represent laboratory, translational, and clinical researchers; other health care professionals; millions of patients with cancer and survivors of cancer; and patient advocates from across the United States. While the Centers for Disease Control and Prevention recognizes that cancer places individuals at higher risk for severe COVID-19, many states are broadening and simplifying the groups eligible for COVID-19 vaccination to speed up distribution of the vaccines. The letter notes that while widespread, rapid vaccination is a worthy goal, the currently limited supply of vaccines means that many who are at high risk for severe illness and death from COVID-19, including patients with active cancer and survivors of cancer, may continue to wait for many months if they are not provided with priority access. Full letter.

Diffusion Pharmaceuticals has announced completion and topline data from the open-label, Phase 1b clinical trial of its novel, diffusion-enhancing therapeutic, trans sodium crocetinate (“TSC”), in hospitalized COVID-19 patients with confirmed hypoxemia, the most common cause of tissue hypoxia. The primary objective of the trial was to evaluate the safety and tolerability of TSC administered on a more frequent dosing regimen not previously tested in a clinical trial setting. Secondary endpoints included pharmacokinetic measurement of TSC levels after dosing, relative improvements in blood oxygen levels, and certain other clinical parameters related to COVID-19. Press release.