Effect of spirulina on risk of hospitalization among patients with COVID-19: the TOGETHER randomized trial.

Autor:	Reis G; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada., Augusto Dos Santos Moreira Silva E; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil., Carla Medeiros Silva D; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil., Thabane L; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada., Santiago Ferreira T; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil., Vitor Quirino Dos Santos C; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil., Paula Figueiredo Guimaraes Almeida A; Department of Public Health at UniFipMoc and Family Medicine Fellowship Program, City of Montes Claros, Minas Gerais, Brazil., Cançado Monteiro Savassi L; Public Health, Mental and Family Medicine Department, Ouro Preto Federal University, Ouro Preto, Minas Gerais, Brazil., Dias de Figueiredo Neto A; Public Health Fellowship Program, Governador Valadares Public Health Authority, Minas Gerais, Brazil., Lanna França Reis L; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil., Helena de Souza Campos V; Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil., Bitarães C; Public Health, Mental and Family Medicine Department, Ouro Preto Federal University, Ouro Preto, Minas Gerais, Brazil; Public Health Care Division, City of Ibirité, Minas Gerais, Brazil., Diniz Callegari E; Public Health Care Division, City of Brumadinho, Minas Gerais, Brazil., Izabel Campos Simplicio M; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil., Barra Ribeiro L; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil., Oliveira R; Research Division, Cardresearch-Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil., Harari O; Purpose Life Sciences, Vancouver, British Columbia, Canada., Forrest JI; Purpose Life Sciences, Vancouver, British Columbia, Canada., Lat PK; Purpose Life Sciences, Vancouver, British Columbia, Canada., Dron L; Cascade Outcomes Research, Vancouver, British Columbia, Canada., Thorlund K; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada., Mills EJ; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Purpose Life Sciences, Vancouver, British Columbia, Canada. Electronic address: millsej@mcmaster.ca.
Jazyk:	angličtina
Zdroj:	The American journal of clinical nutrition [Am J Clin Nutr] 2024 Sep; Vol. 120 (3), pp. 602-609. Date of Electronic Publication: 2024 Aug 15.
DOI:	10.1016/j.ajcnut.2024.06.016
Abstrakt:	Background: Algae-derived nutraceuticals, such as spirulina, have been reported to have biological activities that may minimize clinical consequences to COVID-19 infections. Objectives: This study aimed to determine whether spirulina is an effective treatment for high-risk patients with early COVID-19 in an outpatient setting. Methods: The TOGETHER trial is a placebo-controlled, randomized, platform trial conducted in Brazil. Eligible participants were symptomatic adults with a positive rapid test for SARS-CoV-2 older than 50 y or with a known risk factor for disease severity. Patients were randomly assigned to receive placebo or spirulina (1 g twice daily for 14 d). The primary end point was hospitalization defined as either retention in a COVID-19 emergency setting for >6 h or transfer to tertiary hospital owing to COVID-19 at 28 d. Secondary outcomes included time-to-hospitalization, mortality, and adverse drug reactions. We used a Bayesian framework to compare spirulina with placebo. Results: We recruited 1126 participants, 569 randomly assigned to spirulina and 557 to placebo. The median age was 49.0 y, and 65.3% were female. The primary outcome occurred in 11.2% in the spirulina group and 8.1% in the placebo group (odds ratio [OR]: 1.24; 95% credible interval: 0.84, 1.86). There were no differences in emergency department visit (OR: 1.21; 95% credible interval: 0.81, 1.83), nor time to symptom relief (hazard ratio: 0.90; 95% credible interval: 0.79, 1.03). Spirulina also not demonstrate important treatment effects in the prespecified subgroups defined by age, sex, BMI, days since symptom onset, or vaccination status. Conclusions: Spirulina has no any clinical benefits as an outpatient therapy for COVID-19 compared with placebo with respect to reducing the retention in an emergency setting or COVID-19-related hospitalization. There are no differences between spirulina and placebo for other secondary outcomes. This trial was registered at clinicaltrials.gov as NCT04727424. Competing Interests: Conflict of interest The authors report no conflicts of interest. (Copyright © 2024. Published by Elsevier Inc.)
Databáze:	MEDLINE
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