July 16, 2020 | Columbia researchers have gathered a comprehensive review of COVID-19’s impact on the body outside the lungs and published their findings in Nature Medicine. This, plus more, are included in this week’s announcements and updates from the clinical research industry.

Literature Updates

Columbia researchers have gathered a comprehensive review of COVID-19’s impact on the body outside the lungs and published their findings in Nature Medicine. These impacts include thrombotic complications, myocardial dysfunction and arrhythmia, acute coronary syndromes, acute kidney injury, gastrointestinal symptoms, hepatocellular injury, hyperglycemia and ketosis, neurologic illnesses, ocular symptoms, and dermatologic complications. Given that ACE2, the entry receptor for the causative coronavirus SARS-CoV-2, is expressed in multiple extrapulmonary tissues, direct viral tissue damage is a plausible mechanism of injury, the authors state. DOI: 10.1038/s41591-020-0968-3

Researchers outline the challenges in evaluating the efficacy of the COVID-19 vaccines that are in production in an analysis in the Canadian Medical Association Journal. They emphasize the need to gather adequate sample sizes of vulnerable populations such as seniors, health care workers, Black people and those with risk factors for severe disease and who may have a different response than younger, healthier trial participants, consider public health interventions such as social distancing that may reduce transmission and affect ongoing assessment of SARS-CoV-2 vaccine, and be aware of baseline levels of immunity that could influence a trial outcome. There is a possibility that COVID-19 might be more severe in some people who have been vaccinated (called antibody-dependent enhancement), they note, and suggest vaccine-related ADE be monitored in the long term, as it may be evident only after large numbers of vaccinated people have been exposed to the virus and followed for some time. DOI: 10.1503/cmaj.201237

Researchers in Greece compared patients from 16 countries with acute ischemic strokes and published their findings in Stroke. Between January 27, 2020 to May 19, 2020, there were 174 patients hospitalized with COVID-19 and AIS. Each COVID-19 patient with AIS was matched and compared to a non-COVID-19 AIS patient based on a set of pre-specified factors including age, gender and stroke risk factors (hypertension, diabetes, atrial fibrillation, coronary artery disease, heart failure, cancer, previous stroke, smoking, obesity and dyslipidemia). The final analysis included 330 patients total. In both patient groups, stroke severity was estimated with the National Institute of Health Stroke Scale (NIHSS), and stroke outcome was assessed by the modified Rankin score (mRS). When AIS patients with COVID-19 were compared to non-COVID-19 patients: COVID-19 patients had more severe strokes (median NIHSS score of 10 vs. 6, respectively); COVID-19 patients had higher risk for severe disability following stroke (median mRS score 4 vs. 2, respectively); and COVID-19 patients were more likely to die of AIS. DOI: 10.1161/STROKEAHA.120.031208.

Researchers at University of California San Diego School of Medicine and UC San Diego Health have launched a clinical trial to assess the safety and efficacy of convalescent plasma (CP) to prevent COVID-19 after a known exposure to the virus. CP therapy involves infusing patients with antibodies extracted from the blood of donors who have successfully recovered from COVID-19, with the hope that the resulting boost to their immune systems will shorten the length and reduce the severity of the disease. The UC San Diego trial is part of a larger, national effort approved by the U.S. Food and Drug Administration. The goal is to create a network of hospitals and blood banks collecting, isolating, processing and testing whether plasma from COVID-19 survivors has therapeutic, preventive value. The national trial is being coordinated by Johns Hopkins University and sponsored by the National Institute of Health through the Department of Defense. More information.

The IVY Research Network looked at 249 front-line health care workers who cared for COVID-19 patients during the first month of the pandemic in Tennessee, and found that 8% tested positive for COVID-19 antibodies by serology testing, suggesting they had contracted COVID-19 in the first several weeks of taking care of COVID-19 patients. Among these health care workers with positive serology results, 42% reported no symptoms of a respiratory illness in the prior two months. This suggests that front-line health care workers are at high risk for COVID-19 and that many health care workers with the virus may not have typical symptoms of a respiratory infection. These results were published in the journal Clinical Infectious Diseases. DOI: 10.1093/cid/ciaa936