CORONAVIRUS (COVID-19) UPDATE: FDA AUTHORIZES FIRST COVID-19 DIAGNOSTIC TEST USING BREATH SAMPLES
U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. In the study, the test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified). The performance of the InspectIR COVID-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2% sensitivity (the percent of positive samples the test correctly identified) and 99.3% specificity (the percent of negative samples the test correctly identified).
Full Access: FDA
NEW INSIGHTS INTO IVERMECTIN AND CONVALESCENT PLASMA FOR OUTPATIENTS WITH COVID-19
Ivermectin and convalescent plasma were proposed as treatments for COVID-19 early in the pandemic, but both have been mired in controversy and conflicting results.
In the TOGETHER trial, 1358 outpatients in Brazil with COVID-19 symptoms for ≤7 days and at least 1 risk factor for severe disease were randomized to receive ivermectin (400 µg/kg/day for 3 days) or placebo. The primary endpoint (hospitalization or emergency department observation for >6 hours due to COVID-19) occurred in 14.7% and 16.3% of the ivermectin and placebo groups, respectively; this difference was not statistically significant. There were also no significant between-group differences in viral clearance, hospitalization, length of hospital stay, or symptom score.
Full Access: NEJM
SHOULD WE USE RACE-BASED CORRECTIONS FOR SPIROMETRY?
When interpreting spirometry, published normative values differ among various ethnic groups. In the U.S., spirometers use either race-specific reference values based on the National Health and Nutrition Examination Survey III (conducted from 1988–1994), or a “correction factor” which assumes forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) values for Black patients are roughly 15% lower than for white patients of the same sex, height, and age. Researchers examined data from the MESA Lung Study, when a correction factor was used, FVC had to be 17% lower in a Black participant than in a white participant for a restrictive pattern (FVC <70% predicted) to be diagnosed.
Full Access: NEJM
FOR TREATING SOME CASES OF TB IN CHILDREN, IS A SHORTER REGIMEN AS GOOD AS A LONGER ONE?
Current pediatric treatment recommendations have been extrapolated from adult therapeutic trials, although childhood TB is distinct in many ways (e.g., milder symptoms, greater likelihood of smear-negative disease). In this open-label noninferiority trial in Uganda, Zambia, South Africa, and India, investigators found noninferiority of a 4 month treatment course in children without proven drug-susceptible TB, as well as those living with HIV, is encouraging and likely generalizable to other parts of the world.
Full Access: NEJM