AUTHOR=Aghasadeghi Mohammad Reza , Zaheri Birgani Mohammad Ali , Jamalimoghadamsiyahkali Saeedreza , Hosamirudsari Hadiseh , Moradi Ali , Jafari-Sabet Majid , Sadigh Nooshin , Rahimi Pooneh , Tavakoli Rezvan , Hamidi-Fard Mojtaba , Bahramali Golnaz , Parmoon Zohal , Arjmand Hashjin Sina , Mirzajani Ghasem , Kouhkheil Reza , Roshangaran Somayeh , Khalaf Samineh , Khademi Nadoushan Mohammad , Gholamiyan Yousef Abad Ghazaleh , Shahryarpour Nima , Izadi Mohammad , Zendedel Abolfazl , Jahanfar Shayesteh , Dadras Omid , SeyedAlinaghi SeyedAhmad , Hackett Daniel 

TITLE=Effect of high-dose Spirulina supplementation on hospitalized adults with COVID-19: a randomized controlled trial

JOURNAL=Frontiers in Immunology

VOLUME=15

YEAR=2024

URL=https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1332425

DOI=10.3389/fimmu.2024.1332425

ISSN=1664-3224

ABSTRACT=<sec><title>Objective</title><p><italic>Spirulina</italic> (<italic>arthrospira platensis</italic>) is a cyanobacterium proven to have anti-inflammatory, antiviral, and antioxidant effects. However, the effect of high-dose <italic>Spirulina</italic> supplementation on hospitalized adults with COVID-19 is currently unclear. This study aimed to evaluate the efficacy and safety of high-dose <italic>Spirulina platensis</italic> for SARS-CoV-2 infection.</p></sec><sec><title>Study Design</title><p>We conducted a randomized, controlled, open-label trial involving 189 patients with COVID-19 who were randomly assigned in a 1:1 ratio to an experimental group that received 15.2g of <italic>Spirulina</italic> supplement plus standard treatment (44 non-intensive care unit (non-ICU) and 47 ICU), or to a control group that received standard treatment alone (46 non-ICU and 52 ICU). The study was conducted over six days. Immune mediators were monitored on days 1, 3, 5, and 7. The primary outcome of this study was mortality or hospital discharge within seven days, while the overall discharge or mortality was considered the secondary outcome.</p></sec><sec><title>Results</title><p>Within seven days, there were no deaths in the <italic>Spirulina</italic> group, while 15 deaths (15.3%) occurred in the control group. Moreover, within seven days, there was a greater number of patients discharged in the <italic>Spirulina</italic> group (97.7%) in non-ICU compared to the control group (39.1%) (HR, 6.52; 95% CI, 3.50 to 12.17). Overall mortality was higher in the control group (8.7% non-ICU, 28.8% ICU) compared to the <italic>Spirulina</italic> group (non-ICU HR, 0.13; 95% CI, 0.02 to 0.97; ICU, HR, 0.16; 95% CI, 0.05 to 0.48). In non-ICU, patients who received <italic>Spirulina</italic> showed a significant reduction in the levels of IL-6, TNF-α, IL-10, and IP-10 as intervention time increased. Furthermore, in ICU, patients who received <italic>Spirulina</italic> showed a significant decrease in the levels of MIP-1α and IL-6. IFN-γ levels were significantly higher in the intervention group in both ICU and non-ICU subgroups as intervention time increased. No side effects related to <italic>Spirulina</italic> supplements were observed during the trial.</p></sec><sec><title>Conclusion</title><p>High-dose <italic>Spirulina</italic> supplements coupled with the standard treatment of COVID-19 may improve recovery and remarkably reduce mortality in hospitalized patients with COVID-19.</p></sec><sec><title>Clinical Trial Registration</title><p><ext-link ext-link-type="uri" xlink:href="https://irct.ir/trial/54375" xmlns:xlink="http://www.w3.org/1999/xlink">https://irct.ir/trial/54375</ext-link>, Iranian Registry of Clinical Trials number (IRCT20210216050373N1)</p></sec>