Dataset Information

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

ABSTRACT:

Background

Halofuginone (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.

Methods

We 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.

Results

From 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.

Conclusions

Among 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.

SUBMITTER: Tomazini BM

PROVIDER: S-EPMC10889621 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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Publications

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

Tomazini Bruno Martins BM Tramujas Lucas L Medrado Fernando Azevedo FA Gomes Samara Pinheiro do Carmo SPDC Negrelli Karina Leal KL Murinize Gabriela Souza GS Santos Renato Hideo Nakagawa RHN Vianna Bruna Martins Pereira BMP Piotto Bruna Fornazieri BF Veiga Thabata Silva TS Santos Bianca Rodrigues do BRD Peneluppi Horak Ana Clara AC Lemos Olivia Mora Cavalcante OMC Lopes Marcela de Almeida MA Olicheski Beatriz Baptista BB Campones Diego Lurentt DL Peixoto Luiz Angelo Alencar LAA Basilio Aline Dos Anjos Chaves ADAC Gebara Otavio Celso Eluf OCE Lopes Ana Tarina Alvarez ATA Saconato Humberto H Valeis Nanci N Miranda Tamiris Abait TA Laranjeira Ligia Nasi LN Santucci Eliana Vieira EV Carlin Aaron Foster AF Esko Jeffrey David JD Gordts Phillip Leo Stephan Marie PLSM Tsimikas Sotirios S Cavalcanti Alexandre Biasi AB

PloS one 20240223 2

<h4>Background</h4>Halofuginone (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.<h4>Methods</h4>We 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 randomi ...[more]

PMID: 38394069

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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