Safety and efficacy of sirolimus in hospitalised patients with COVID-19 pneumonia.
Clinical trial
Rapamycin
SARS-CoV-2
SCOPE
mTOR
Journal
Respiratory investigation
ISSN: 2212-5353
Titre abrégé: Respir Investig
Pays: Netherlands
ID NLM: 101581124
Informations de publication
Date de publication:
Mar 2024
Mar 2024
Historique:
received:
12
10
2023
revised:
11
12
2023
accepted:
22
12
2023
medline:
26
2
2024
pubmed:
12
1
2024
entrez:
11
1
2024
Statut:
ppublish
Résumé
There is a critical need to develop novel therapies for COVID-19. We conducted a phase 2, multicentre, placebo-controlled, double-blind, randomised trial; hospitalised patients with hypoxemic respiratory failure due to COVID-19 and at least one poor prognostic biomarker, were given sirolimus (6 mg on Day 1 followed by 2 mg daily for 14 days or hospital discharge, whichever happens first) or placebo, in a 2:1 randomization scheme favouring sirolimus. Primary outcome was the proportion of patients alive and free from advanced respiratory support measures at Day 28. Between April 2020 and April 2021, 32 patients underwent randomization and 28 received either sirolimus (n = 18) or placebo (n = 10). Mean age was 57 years and 75 % of the subjects were men. Twenty-two subjects had at least one co-existing condition (Diabetes, hypertension, obesity, CHF, or asthma/COPD) associated with worse prognosis. Mean FiO Larger studies are warranted to evaluate the role sirolimus in COVID-19 infection.
Sections du résumé
BACKGROUND
BACKGROUND
There is a critical need to develop novel therapies for COVID-19.
METHODS
METHODS
We conducted a phase 2, multicentre, placebo-controlled, double-blind, randomised trial; hospitalised patients with hypoxemic respiratory failure due to COVID-19 and at least one poor prognostic biomarker, were given sirolimus (6 mg on Day 1 followed by 2 mg daily for 14 days or hospital discharge, whichever happens first) or placebo, in a 2:1 randomization scheme favouring sirolimus. Primary outcome was the proportion of patients alive and free from advanced respiratory support measures at Day 28.
RESULTS
RESULTS
Between April 2020 and April 2021, 32 patients underwent randomization and 28 received either sirolimus (n = 18) or placebo (n = 10). Mean age was 57 years and 75 % of the subjects were men. Twenty-two subjects had at least one co-existing condition (Diabetes, hypertension, obesity, CHF, or asthma/COPD) associated with worse prognosis. Mean FiO
CONCLUSIONS
CONCLUSIONS
Larger studies are warranted to evaluate the role sirolimus in COVID-19 infection.
Identifiants
pubmed: 38211546
pii: S2212-5345(24)00002-9
doi: 10.1016/j.resinv.2023.12.009
pii:
doi:
Substances chimiques
Sirolimus
W36ZG6FT64
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
216-222Informations de copyright
Published by Elsevier B.V.
Déclaration de conflit d'intérêts
Declaration of competing interest The authors report no conflict of interest.