With the first reports on coronavirus disease 2019 (COVID-19), which is caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the scientific community working in the field of type III IFNs (IFN-λ) realized that this class of IFNs could play an important role in this and other emerging viral infections. In this Viewpoint, we present our opinion on the benefits and potential limitations of using IFN-λ to prevent, limit, and treat these dangerous viral infections.
This article discusses data safety monitoring during Covid‐19. the pandemic of Covid‐19 has created the imperative for new treatments and a vaccine, countless clinical trials already in progress have still needed oversight. With the emergence of Covid-19, studies needed to quickly adapt because what it meant to protect study participants wasn’t the same as it had been weeks earlier. One of the primary roles of DSMBs is to evaluate interim data to ensure that participants aren’t at additional risk by virtue of being randomized to a study arm found to have more risks or fewer benefits than other arms. Stopping a study early when it falls out of equipoise is the most monumental task a data safety monitoring boards (DSMB) is charged to perform. The pandemic brought with it risks that changed many studies’ risk-benefit calculus. In some cases, merely attending a visit to report symptoms, check progress, verify pill counts, or report adverse events posed additional risk. Participants in placebo arms are typically expected to experience little benefit, and certainly not greater harm, than participants in the active therapy group. Suddenly, participating in even the most innocuous placebo arm might result in unforeseen harm. DSMBs’ primary responsibility is to protect research participants, but if data is compromised, then the benefit of the study will never outweigh the risks to participants. Thus, protecting the integrity of data collection was also foremost in the minds of DSMB members. Researchers, representatives from the National Institutes of Health, and DSMB members were in constant communication about trials already in progress.
Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of Diagnostic Testing for SARS–CoV-2/COVID-1903/26/2020
As we enter the second quarter of the COVID-19 pandemic, with testing for severe acute respiratory syndrome coronavirus 2 (SARS–CoV-2) increasingly available (though still limited and/or slow in some areas), we are faced with new questions and challenges regarding this novel virus. When to test? Whom to test? What to test? How often to test? And, what to do with test results? Since SARS–CoV-2 is a new virus, there is little evidence to fall back on for test utilization and diagnostic stewardship (1). Several points need to be considered to begin answering of these questions; specifically, what types of tests are available and under which circumstances are they useful? This understanding can help guide the use of testing at the local, regional, state, and national levels and inform those assessing the supply chain to ensure that needed testing is and continues to be available. Here, we explain the types of tests available and how they might be useful in the face of a rapidly changing and never-before-experienced situation. There are two broad categories of SARS–CoV-2 tests: those that detect the virus itself and those that detect the host’s response to the virus. Each will be considered separately.
We must recognize that we are dealing with (i) a new virus, (ii) an unprecedented pandemic in modern times, and (iii) uncharted territory. With this in mind, in the absence of either proven effective therapy or a vaccine, diagnostic testing, which we have, becomes an especially important tool, informing patient management and potentially helping to save lives by limiting the spread of SARS–CoV-2. What is the most appropriate test, and for whom and when?
Hypothetically, if the entire world’s population could be tested all at once, with a test providing 100% specificity and sensitivity (unrealistic, obviously), we might be able to identify all infected individuals and sort people into those who at that moment in time were asymptomatic, minimally/moderately symptomatic, and severely symptomatic. The asymptomatic and minimally/moderately symptomatic could be quarantined to avoid the spread of the virus, with the severely symptomatic managed and isolated in health care settings. Contract tracing could be carried out to find those at risk of being in the incubation period by virtue of their exposure. Alternatively, testing for a host response, if, again, the test were hypothetically 100% sensitive and specific, could identify those previously exposed to the virus and (if we knew this to be true, which we do not) label those who are immune to the virus, who could be tapped to work in settings where potentially infected individuals (e.g., sick patients in hospitals) might otherwise pose a risk. Unfortunately, these hypothetical scenarios are not reality. However, with this ideal situation as a guide, what we do have available as tests today should be carefully considered in terms of how they can be leveraged to move the current crisis closer to the ideal situation, especially in the absence of therapeutics or vaccines.
Although the virus can be cultured, this is dangerous and not routinely done in clinical laboratories. While detection of viral antigens is theoretically possible, this approach has not, to date, been a primary one, but one that those participating in the summit considered to deserve further research.
Increases in Risky Drinking During the COVID-19 Pandemic Assessed via Longitudinal Cohort Design: Associations With Racial Tensions, Financial Distress, Psychological Distress and Virus-Related Fears03/2021
The COVID-19 pandemic has created disruptions to daily life resulting in wide-spread unemployment and psychological distress. Recent studies have reported high rates of alcohol use during this time; however, longitudinal data remain scarce and factors associated with increases in high-risk drinking observed over time are unknown.
The current study examined changes in high-risk drinking patterns across four 7-day observation periods, prior to and following a university wide campus closure. Additionally, factors associated with changes in alcohol use patterns were examined including financial distress, psychological distress, impact of racial tensions and virus-related fears.
Students (N = 1001) in the Midwestern USA completed repeated assessments between March and June 2020. Each survey included a timeline follow-back measure of alcohol use. Pandemic-related distress spanning several factors was assessed at the final follow-up.
Risky drinking patterns increased significantly over time. Overall, psychological distress and impact of racial tensions were associated with higher rates of risky drinking, whereas COVID-19-related fears were associated with lower rates. However, only financial-related distress was associated with an increase in risky drinking patterns over time.
Increased risky drinking patterns observed in the current study may signal problems that are likely to persist even after the direct impact of the COVID-19 pandemic on daily life ends. Individuals experiencing financial distress may represent a particularly high-risk group. Interventions targeting the cross-section of job loss, financial stress and problematic alcohol use will be important to identify.