Fig. 3: Results of in silico clinical trials in prophylaxis of respiratory tract infections (RTIs) with four scenarios of non-pharmaceutical interventions (NPIs) against COVID-19 pandemic with increasing strength (absent - dark purple, mild - light purple, medium - light red, and strong - yellow) modeled by a decrease of the transmission rate parameter (no reduction, −5%, −15% and −25%, respectively). | Nature Communications

Fig. 3: Results of in silico clinical trials in prophylaxis of respiratory tract infections (RTIs) with four scenarios of non-pharmaceutical interventions (NPIs) against COVID-19 pandemic with increasing strength (absent - dark purple, mild - light purple, medium - light red, and strong - yellow) modeled by a decrease of the transmission rate parameter (no reduction, −5%, −15% and −25%, respectively).

From: Modeling the disruption of respiratory disease clinical trials by non-pharmaceutical COVID-19 interventions

Fig. 3

For all scenarios, the simulations are run for 2 years. Year 1 is the selection year during which patients are screened and possibly included in an in silico trial. There is no NPI during year 1. The NPIs are started at the beginning of year 2 as well as the treatment (ten daily administrations of 3.5 mg of OM-85 from the beginning of the month for 3 consecutive months). RTIs are counted for the complete duration of year 2. a Weekly incidence of RTIs per 100,000 is plotted for 2 years of simulations for the four NPI scenarios. b Distribution (interquartile range, IQR) of absolute benefit (number of prevented RTIs in year 2) is plotted for the four NPI scenarios. Absolute benefit can be interpreted as the number of prevented RTIs in year 2 when comparing the treated and the control group. c Distribution (IQR) of event RTI rate ratio (ERR, treated over control group) is plotted for the four NPI scenarios. d Effect Model plot for the four NPI scenarios. Each in silico clinical trial is plotted (symbols) with the number of RTIs in the control group as x-coordinate and the number of RTIs in the treated group as y coordinate. The region of clinically relevant efficacy is indicated in orange. It is defined by at least 1 prevented RTI in absolute benefit (dashed-dotted line), at least 20% reduction in number of RTIs (solid line) and at least 3 RTIs in the control group. e Distribution (IQR) of sample sizes per arm required to show efficacy of OM-85 treatment in reducing number of RTIs for the four NPI scenarios. f Distribution (IQR) of estimated patient screening times under the four NPI scenarios by assuming a hypothetical screening rate of 1000 patients per year and by taking year 2 as the selection year (without treatment). Sensitivity of these results to mechanistic uncertainty is reported in Supplementary Fig. 14.

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