Evidence map›Paper›PMID 36839987›Full record

ArticlePharmaceutics2023

Efficacy and Safety of Inhaled Ethanol in Early-Stage SARS-CoV-2 Infection in Older Adults: A Phase II Randomized Clinical Trial.

Ana Castro-Balado, Ignacio Novo-Veleiro, Néstor Vázquez-Agra, Gema Barbeito-Castiñeiras, Ana Estany-Gestal, Rocío Trastoy-Pena, Miguel González-Barcia, Irene Zarra-Ferro, María Carmen Del Río-Garma, Carlos Crespo-Diz and 5 more

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 43% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

15 authors at 4 institutions in 1 country.

Ana Castro-BaladoPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.ORCID 0000-0001-5168-114X
Ignacio Novo-VeleiroInternal Medicine Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
Néstor Vázquez-AgraInternal Medicine Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.ORCID 0000-0003-3227-8990
Gema Barbeito-CastiñeirasMicrobiology Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.ORCID 0000-0002-5889-9106
Ana Estany-GestalEpidemiology and Clinical Research Unit, Health Research Institute of Santiago de Compostela (IDIS), 15706 Santiago de Compostela, Spain.
Rocío Trastoy-PenaMicrobiology Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.ORCID 0000-0003-4580-7126
Miguel González-BarciaPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
Irene Zarra-FerroPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
María Carmen Del Río-GarmaClinical Analytic Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
Carlos Crespo-DizPharmacy Department, University Clinical Hospital of Pontevedra (SERGAS), 36162 Pontevedra, Spain.
Olga Delgado-SánchezSociedad Española de Farmacia Hospitalaria (SEFH), 28001 Madrid, Spain.
Francisco J Otero-EspinarPharmacology, Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Santiago de Compostela (USC), 15782 Santiago de Compostela, Spain.ORCID 0000-0001-9030-2253
Cristina Mondelo-GarcíaPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.ORCID 0000-0001-8555-1415
Antonio Pose-ReinoInternal Medicine Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
Anxo Fernández-FerreiroPharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.ORCID 0000-0002-7348-7337
Universidade de Santiago de Compostela · ESInstituto de Investigación Sanitaria de Santiago · ESServicio Gallego de Salud · ESSociedad Española de Farmacología Clínica · ES

Funding

Axencia de Coñecemento en Saúde CT850A-4Fundacion Española de Farmacia Hospitalaria FEFHInstituto de Salud Carlos III CM21/00068Instituto de Salud Carlos III CM21/00114Instituto de Salud Carlos III JR18/00014Instituto de Salud Carlos III JR20/00026
6 · The paper itself

Abstract

backgroundInhaled ethanol in the early stages of SARS-CoV-2 infection may reduce the viral load, decreasing progression and improving prognosis. The ALCOVID-19 trial was designed to study the efficacy and safety of inhaled ethanol in older adults at initial phases of infection.

methodsRandomized, triple-blind, placebo-controlled phase II clinical trial. Experimental group (n = 38) inhaled 65° ethanol through an oxygen flow, while in the control group (n = 37), water for injection was used. General endpoint was to evaluate disease progression according to the modified World Health Organization (WHO) Clinical Progression Scale. Specific effectiveness endpoints were body temperature, oxygen saturation, viral load assessed by cycle threshold (Ct) on real-time polymerase chain reaction (RT-PCR), analytical biomarkers and use of antibiotics or corticosteroids. Specific safety outcomes were the absence of ethanol in plasma, electrographic, analytical, or respiratory alterations.

resultsIn the intention-to-treat population, no differences were found regarding disease progression. Mean Ct values increased over time in both groups, being numerically higher in the ethanol group, reaching a value above 33 only in the ethanol group on day 14, a value above which patients are considered non-infective. No differences were found in the other specific effectiveness endpoints. Inhaled ethanol was proven to be safe as no plasma ethanol was detected, and there were no electrocardiographic, analytical, or respiratory alterations.

conclusionsThe efficacy of inhaled ethanol in terms of the progression of SARS-CoV-2 infection was not demonstrated in the present trial. However, it is positioned as a safe treatment for elderly patients with early-stage COVID-19.

Indexed as

COVID-19elderlyinhaled ethanolrandomized controlled trialSARS-CoV-2

Identifiers

PMID36839987
PMCPMC9966500
OpenAlexW4321104261

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.