Evidence map›Paper›PMID 38394069›Full record

Trial reportPloS one2024

Halofuginone for non-hospitalized adult patients with COVID-19 a multicenter, randomized placebo-controlled phase 2 trial. The HALOS trial.

Bruno Martins Tomazini, Lucas Tramujas, Fernando Azevedo Medrado, Samara Pinheiro do Carmo Gomes, Karina Leal Negrelli, Gabriela Souza Murinize, Renato Hideo Nakagawa Santos, Bruna Martins Pereira Vianna, Bruna Fornazieri Piotto, Thabata Silva Veiga and 20 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 8% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

30 authors at 4 institutions in 2 countries.

Bruno Martins TomaziniHcor Research Institute, São Paulo (SP), Brazil.ORCID 0000-0001-6763-6132
Lucas TramujasHcor Research Institute, São Paulo (SP), Brazil.ORCID 0000-0002-6003-1314
Fernando Azevedo MedradoHcor Research Institute, São Paulo (SP), Brazil.
Samara Pinheiro do Carmo GomesHcor Research Institute, São Paulo (SP), Brazil.
Karina Leal NegrelliHcor Research Institute, São Paulo (SP), Brazil.
Gabriela Souza MurinizeHcor Research Institute, São Paulo (SP), Brazil.
Renato Hideo Nakagawa SantosHcor Research Institute, São Paulo (SP), Brazil.
Bruna Martins Pereira ViannaHcor Research Institute, São Paulo (SP), Brazil.
Bruna Fornazieri PiottoHcor Research Institute, São Paulo (SP), Brazil.
Thabata Silva VeigaHcor Research Institute, São Paulo (SP), Brazil.
Bianca Rodrigues do SantosHcor Research Institute, São Paulo (SP), Brazil.
Ana Clara Peneluppi HorakHcor Research Institute, São Paulo (SP), Brazil.
Olivia Mora Cavalcante LemosHospital do Coração (HCor), São Paulo (SP), Brazil.
Marcela de Almeida LopesHcor Research Institute, São Paulo (SP), Brazil.
Beatriz Baptista OlicheskiHospital do Coração (HCor), São Paulo (SP), Brazil.
Diego Lurentt CamponesHospital do Coração (HCor), São Paulo (SP), Brazil.
Luiz Angelo Alencar PeixotoHospital do Coração (HCor), São Paulo (SP), Brazil.
Aline Dos Anjos Chaves BasilioHospital do Coração (HCor), São Paulo (SP), Brazil.
Otavio Celso Eluf GebaraHospital Santa Paula, São Paulo (SP), Brazil.
Ana Tarina Alvarez LopesHospital Santa Paula, São Paulo (SP), Brazil.
Humberto SaconatoHospital Santa Paula, São Paulo (SP), Brazil.
Nanci ValeisHcor Research Institute, São Paulo (SP), Brazil.
Tamiris Abait MirandaHcor Research Institute, São Paulo (SP), Brazil.
Ligia Nasi LaranjeiraHcor Research Institute, São Paulo (SP), Brazil.
Eliana Vieira SantucciHcor Research Institute, São Paulo (SP), Brazil.
Aaron Foster CarlinDepartments of Pathology and Medicine, University of California, San Diego, La Jolla, California, United States of America.
Jeffrey David EskoDepartment of Cellular and Molecular Medicine and Glycobiology Research and Training Center, University of California, San Diego, La Jolla, California, United States of America.
Phillip Leo Stephan Marie GordtsDepartment of Medicine, and Glycobiology Research and Training Center, University of California, San Diego, La Jolla, California, United States of America.
Sotirios TsimikasDivision of Cardiovascular Medicine, Sulpizio Cardiovascular Center, University of California San Diego, La Jolla, California, United States of America.
Alexandre Biasi CavalcantiHcor Research Institute, São Paulo (SP), Brazil.
Hospital do Coração · BRUniversity of California San Diego · USHospital Santa Paula · BRBrazilian Research in Intensive Care Network · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHalofuginone (PJS-539) is an oral prolyl-tRNA synthetase inhibitor that has a potent in vitro activity against SARS-CoV-2 virus. The safety and efficacy of halofuginone in Covid-19 patients has not been studied.

methodsWe conducted a phase II, randomized, double-blind, placebo-controlled, dose ranging, safety and tolerability trial of halofuginone in symptomatic (≤ 7 days), mostly vaccinated, non-hospitalized adults with mild to moderate Covid-19. Patients were randomized in a 1:1:1 ratio to receive halofuginone 0.5mg, 1mg or placebo orally once daily for 10 days. The primary outcome was the decay rate of the SARS-CoV-2 viral load logarithmic curve within 10 days after randomization.

resultsFrom September 25, 2021, to February 3, 2022, 153 patients were randomized. The mean decay rate in SARS-CoV-2 viral load log10 within 10 days was -3.75 (95% CI, -4.11; -3.19) in the placebo group, -3.83 (95% CI, -4.40; -2.27) in the halofuginone 0.5mg group and -4.13 (95% CI, -4.69; -3.57) in the halofuginone 1mg group, with no statistically significant difference in between placebo vs. halofuginone 0.5mg (mean difference -0.08; 95% CI -0.82 to 0.66, p = 0.96) and between placebo vs. halofuginone 1mg (mean difference -0.38; 95% CI, -1.11; 0.36, p = 0.41). There was no difference on bleeding episodes or serious adverse events at 28 days.

conclusionsAmong non-hospitalized adults with mild to moderate Covid-19 halofuginone treatment was safe and well tolerated but did not decrease SARS-CoV-2 viral load decay rate within 10 days.

Indexed as

COVID-19PiperidinesQuinazolinonesAdultDouble-Blind MethodHumansSARS-CoV-2Time FactorshalofuginonePiperidinesQuinazolinones

Identifiers

PMID38394069
PMCPMC10889621
OpenAlexW4392123322

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.