February 20, 2025

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COVID

COVID-19 Case Fatality Rate and Infection Fatality Rate from 2020 to 2023: Nationwide Analysis in Austria
This retrospective observational study included all Austrian residents and covered the time from February 2020 to May 2023, examining CFRs overall, monthly, and during dominant SARS-CoV-2 variant periods. CFRs were calculated for the whole population and stratified according to immunization status (presence of previous vaccination and/or infection), age, gender and nursing home residency. They additionally estimated the IFRs based on estimations of undocumented infections using a test positivity model. The overall CFR of 30-day COVID-19 mortality was 0.31 % but varied depending on month, with the highest being 5.9 % in April 2020 and the lowest 0.07 % in January 2022. The variant periods reflected this trend of decreasing CFR, with the highest for Wuhan-Hu-1 (2.05 %) and the lowest for BA.1 (0.08 %). Overall CFRs were particularly high in the group without any previous immunizing event (0.67 %), the elderly (85 + year group: 7.88 %) and in nursing home residents (7.92 %). Nursing home residents accounted for 30.82 % of all COVID-19 deaths while representing only 1.22 % of diagnosed infections. Total SARS-CoV-2 infections were estimated to be 47 % higher than confirmed cases with a corresponding overall IFR of 0.16 %.

COVID: Early Viral Phase

A Randomized, Double-blind, Phase 1, Single- and Multiple-dose Placebo-controlled Study of the Safety and Pharmacokinetics of IN-006, an Inhaled Antibody Treatment for COVID-19 in Healthy Volunteers
A Phase 1 study was conducted in healthy volunteers aged 18-55 a Phase 1 unit in Melbourne, Australia (ACTRN12621001235897). Study staff and participants were blinded to treatment assignment, except for pharmacy staff preparing the study drug. The ratio of active:placebo randomization to each cohort was set at 3:1. The primary outcomes were safety and tolerability. Exploratory outcomes were pharmacokinetics of IN-006 in nasal fluid and serum. Twenty-three participants were enrolled and randomized across two single dose and one multiple dose cohorts (30 mg or 90 mg single nebulized dose, or seven daily 90 mg doses). There were no serious adverse events. All enrolled participants completed the study without treatment interruption or discontinuation. All treatment-emergent adverse events were transient, non-dose dependent, and graded mild to moderate in severity. Nebulization was well-tolerated and completed in an average of six minutes. Geometric mean nasal fluid concentrations of IN-006 in the multiple dose cohort were 739.8 μg/mL at 30 minutes after dosing and 1.2 μg/mL at 22 hours. Geometric mean serum levels in the multiple dose cohort peaked at 0.51 μg/mL three days after the final dose. They note that these concentrations in the respiratory tract are orders of magnitude above the IC50 range typical of antiviral mAbs.
Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial
These are results from a global phase 3 trial, nonhospitalized adults with mild-to-moderate coronavirus disease 2019 (COVID-19) and symptom onset within five days were randomized (1:1) to receive once-daily ensitrelvir (375 mg day 1, 125 mg days 2–5) or blinded matching placebo. The primary endpoint was the restricted mean time to sustained (≥2 days) resolution of 15 COVID-19 symptoms, recorded in participant daily diaries, through day 29 in participants starting treatment within three days after symptom onset. Virologic efficacy and safety were assessed. Of 2,093 participants, 1,888 started treatment within three days after symptom onset. Mean time to symptom resolution was 12.5 and 13.1 days with ensitrelvir and placebo, respectively. They conclude by saying “Despite the evidence of antiviral activity with ensitrelvir, this trial did not demonstrate a significant difference in time to sustained symptom resolution.”