Evidence map›Paper›PMID 27821093›Full record

Trial reportBMC infectious diseases2016

Inosine pranobex is safe and effective for the treatment of subjects with confirmed acute respiratory viral infections: analysis and subgroup analysis from a Phase 4, randomised, placebo-controlled, double-blind study.

Jiří Beran, Eva Šalapová, Marian Špajdel, Isoprinosine Study (EWO ISO-2014/1) Team

Open access · goldAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

16 citing papers in PubMed, 34 citations in OpenAlex.

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  12. Battling COVID-19: using old weapons for a new enemy.Tropical diseases, travel medicine and vaccines · 2020
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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

4 authors at 2 institutions in 3 countries.

Jiří BeranVaccination and Travel Medicine Centre, Tylovo nábřeží 418/6, 500 02, Hradec Králové, Czech Republic. jiri.beran@vakcinace.cz.ORCID 0000-0002-5119-4197
Eva ŠalapováEwopharma International, s.r.o., Hlavná 13, 831 01, Bratislava, Slovakia.
Marian ŠpajdelUniversity of Trnava, Hornopotočná 23, 918 43, Trnava, Slovakia.
Isoprinosine Study (EWO ISO-2014/1) Team
Charles University · CZUniversity of Trnava · SK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInosine pranobex (Isoprinosine®) is an immunomodulatory drug approved in several countries for the treatment of viral infections. This study compared the efficacy and safety of inosine pranobex versus placebo in subjects with clinically diagnosed influenza-like illness, including subjects with laboratory-confirmed acute respiratory viral infections. Subgroup analyses evaluated the efficacy of inosine pranobex compared to placebo in otherwise healthy (without related ongoing disease) subjects that were less than 50 years of age and healthy subjects that were at least 50 years of age. The effect of body mass index (BMI) was evaluated in subjects less than 50 years of age.

methodsA total of 463 subjects were randomly assigned to receive inosine pranobex (n = 231) or placebo (n = 232) in this Phase 4, randomised, double-blind, multicentre study. The primary efficacy endpoint was time to resolution of all influenza-like symptoms present at baseline to none. Safety was evaluated through analysis of adverse events, vital signs, and physical examinations.

resultsThe difference in time to resolution of all influenza-like symptoms between treatment groups was not statistically significant but showed a faster improvement in subjects in the inosine pranobex group versus those in the placebo group - Hazard Ratio = 1.175; (95 % CI: 0.806-1.714). P-value = 0.324. In the subgroup analysis for subjects less than 50 years of age, statistically significant differences in time to resolution of influenza-like symptoms that favoured the inosine pranobex group over the placebo group were observed in those without related ongoing disease and those who were non-obese (BMI <30 kg/m

conclusionsThe study results indicate the safety of inosine pranobex for the treatment of subjects with confirmed acute respiratory viral infections and confirm the efficacy of inosine pranobex versus placebo in healthy non-obese subjects less than 50 years of age with clinically diagnosed influenza-like illnesses.

trial registrationEWO-ISO-2014/1, EudraCT 2014-001863-11 ; Date of registration: 29 APR 2014; Detail information web link: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-001863-11/results.

Indexed as

Acute DiseaseAdultAntiviral AgentsDouble-Blind MethodFemaleHumansInfluenza, HumanInosine PranobexMaleMiddle AgedTreatment OutcomeAntiviral AgentsInosine PranobexEfficacyImmunomodulatorImmunosenescenceInfluenzaInosine pranobexIsoprinosineSafetyViral infection

Identifiers

PMID27821093
PMCPMC5100179
OpenAlexW2550148687

What OpenQuestion holds

Textmetadata
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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.