tetano
Editor, Senior Moderator
Am J Clin Nutr
. 2024 Sep;120(3):602-609.
doi: 10.1016/j.ajcnut.2024.06.016. Epub 2024 Aug 15. Effect of spirulina on risk of hospitalization among patients with COVID-19: the TOGETHER randomized trial
Gilmar Reis[SUP] 1 [/SUP], Eduardo Augusto Dos Santos Moreira Silva[SUP] 2 [/SUP], Daniela Carla Medeiros Silva[SUP] 2 [/SUP], Lehana Thabane[SUP] 3 [/SUP], Thiago Santiago Ferreira[SUP] 4 [/SUP], Castilho Vitor Quirino Dos Santos[SUP] 2 [/SUP], Ana Paula Figueiredo Guimaraes Almeida[SUP] 5 [/SUP], Leonardo Cançado Monteiro Savassi[SUP] 6 [/SUP], Adhemar Dias de Figueiredo Neto[SUP] 7 [/SUP], Luiza Lanna França Reis[SUP] 2 [/SUP], Vitoria Helena de Souza Campos[SUP] 8 [/SUP], Carina Bitarães[SUP] 9 [/SUP], Eduardo Diniz Callegari[SUP] 10 [/SUP], Maria Izabel Campos Simplicio[SUP] 4 [/SUP], Luciene Barra Ribeiro[SUP] 4 [/SUP], Rosemary Oliveira[SUP] 4 [/SUP], Ofir Harari[SUP] 11 [/SUP], Jamie I Forrest[SUP] 11 [/SUP], Prince Kumar Lat[SUP] 11 [/SUP], Louis Dron[SUP] 12 [/SUP], Kristian Thorlund[SUP] 3 [/SUP], Edward J Mills[SUP] 13 [/SUP]
Affiliations
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.
Keywords: Brazil; SARS-CoV-2; outpatients; repurposed drugs; spirulina.
. 2024 Sep;120(3):602-609.
doi: 10.1016/j.ajcnut.2024.06.016. Epub 2024 Aug 15. Effect of spirulina on risk of hospitalization among patients with COVID-19: the TOGETHER randomized trial
Gilmar Reis[SUP] 1 [/SUP], Eduardo Augusto Dos Santos Moreira Silva[SUP] 2 [/SUP], Daniela Carla Medeiros Silva[SUP] 2 [/SUP], Lehana Thabane[SUP] 3 [/SUP], Thiago Santiago Ferreira[SUP] 4 [/SUP], Castilho Vitor Quirino Dos Santos[SUP] 2 [/SUP], Ana Paula Figueiredo Guimaraes Almeida[SUP] 5 [/SUP], Leonardo Cançado Monteiro Savassi[SUP] 6 [/SUP], Adhemar Dias de Figueiredo Neto[SUP] 7 [/SUP], Luiza Lanna França Reis[SUP] 2 [/SUP], Vitoria Helena de Souza Campos[SUP] 8 [/SUP], Carina Bitarães[SUP] 9 [/SUP], Eduardo Diniz Callegari[SUP] 10 [/SUP], Maria Izabel Campos Simplicio[SUP] 4 [/SUP], Luciene Barra Ribeiro[SUP] 4 [/SUP], Rosemary Oliveira[SUP] 4 [/SUP], Ofir Harari[SUP] 11 [/SUP], Jamie I Forrest[SUP] 11 [/SUP], Prince Kumar Lat[SUP] 11 [/SUP], Louis Dron[SUP] 12 [/SUP], Kristian Thorlund[SUP] 3 [/SUP], Edward J Mills[SUP] 13 [/SUP]
Affiliations
- PMID: 39232602
- DOI: 10.1016/j.ajcnut.2024.06.016
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.
Keywords: Brazil; SARS-CoV-2; outpatients; repurposed drugs; spirulina.