Evidence map›Paper›PMID 35418135›Full record

ArticleNature communications2022

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 and 3 more

Open access · goldAbstract read
In one paragraph

Article in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. In Silico Clinical Trials: Is It Possible?Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Simon ArsèneNovadiscovery SA, Lyon, France.
Claire Couty *Novadiscovery SA, Lyon, France.ORCID http://orcid.org/0000-0001-9167-7428
Igor Faddeenkov *Novadiscovery SA, Lyon, France.
Natacha Go *Novadiscovery SA, Lyon, France.
Solène Granjeon-Noriot *Novadiscovery SA, Lyon, France.
Daniel ŠmítNovadiscovery SA, Lyon, France.
Riad KahoulNovadiscovery SA, Lyon, France.ORCID http://orcid.org/0000-0002-6181-7466
Ben IlligensNovadiscovery SA, Lyon, France.
Jean-Pierre BoisselNovadiscovery SA, Lyon, France.
Aude ChevalierOM Pharma, Meyrin, Switzerland.
Lorenz LehrOM Pharma, Meyrin, Switzerland.
Christian PasqualiOM Pharma, Meyrin, Switzerland.
Alexander KuleszaNovadiscovery SA, Lyon, France. Alexander.Kulesza@novadiscovery.com.ORCID http://orcid.org/0000-0002-8812-8548
Dresden International University · DEMicroDiscovery (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

COVID-19Respiration DisordersRespiratory Tract InfectionsVirus DiseasesClinical Trials as TopicCommunicable Disease ControlHumansSARS-CoV-2

Identifiers

PMID35418135
PMCPMC9008035
OpenAlexW4223566380

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.