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

Simon Arsène, Claire Couty, Igor Faddeenkov, Natacha Go, Solène Granjeon-Noriot, Daniel Šmít, Riad Kahoul, Ben Illigens, Jean-Pierre Boissel, Aude Chevalier, Lorenz Lehr, Christian Pasquali and Alexander Kulesza ()
Additional contact information
Simon Arsène: Novadiscovery SA
Claire Couty: Novadiscovery SA
Igor Faddeenkov: Novadiscovery SA
Natacha Go: Novadiscovery SA
Solène Granjeon-Noriot: Novadiscovery SA
Daniel Šmít: Novadiscovery SA
Riad Kahoul: Novadiscovery SA
Ben Illigens: Novadiscovery SA
Jean-Pierre Boissel: Novadiscovery SA
Aude Chevalier: OM Pharma
Lorenz Lehr: OM Pharma
Christian Pasquali: OM Pharma
Alexander Kulesza: Novadiscovery SA

Nature Communications, 2022, vol. 13, issue 1, 1-10

Abstract: Abstract Respiratory disease trials are profoundly affected by non-pharmaceutical interventions (NPIs) against COVID-19 because they perturb existing regular patterns of all seasonal viral epidemics. To address trial design with such uncertainty, we developed an epidemiological model of respiratory tract infection (RTI) coupled to a mechanistic description of viral RTI episodes. We explored the impact of reduced viral transmission (mimicking NPIs) using a virtual population and in silico trials for the bacterial lysate OM-85 as prophylaxis for RTI. Ratio-based efficacy metrics are only impacted under strict lockdown whereas absolute benefit already is with intermediate NPIs (eg. mask-wearing). Consequently, despite NPI, trials may meet their relative efficacy endpoints (provided recruitment hurdles can be overcome) but are difficult to assess with respect to clinical relevance. These results advocate to report a variety of metrics for benefit assessment, to use adaptive trial design and adapted statistical analyses. They also question eligibility criteria misaligned with the actual disease burden.

Date: 2022
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-022-29534-8 Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-29534-8

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-022-29534-8

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().