Efficacy of L. Plantarum and P. Acidilactici in Adults With SARS-CoV-2 and COVID-19
Condition: SARS-CoV Infection
MeSH terms: Severe Acute Respiratory Syndrome
Study type: Interventional

Summary: 
      Clinical research focused to evaluate the effect as coadyuvant of a combination of L.
      plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19
      symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to
      progress to moderate or severe COVID and associated advantages such as reduce the risk of
      death. Adittionnally this RCT is launching to explore the benefits of this combination of
      strains to modulate fecal microbiome and explore how this correlate with clinical
      improvement.
    

Detailed description: 
      Randomized controlled trial (RCT) to evaluate safety and efficacy of Lactobacillus plantarum
      CECT 30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485 y P.
      acidilactici CECT 7483, one dose a day to reduce the risk of subjects with mild COVID-19 to
      evolute to moderate or severe disease. As secondary aims this trial is intented to evaluate
      the effect of this strains combinations to reduce the frequency and severity of
      gastrointestinal COVID-19 symptoms and lung abnormalities, to reduce the viral load, modulate
      the levels of IgG/IgM, and positively modify the fecal microbiota.

      300 adults, 18 to 60 years, RTq-PCR positive for SARS-CoV-2, with mild COVID-19, and SpO2 >
      90%, living in Mexico city (2,200m over the sea level) will be randomized, after sign of
      informed consent to receive a combintation of Lactobacillus plantarum CECT 30292,
      Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485 y P. acidilactici CECT
      7483 one a day orally or placebo for 30 days.

      Clinical severity, lung abnormalities (x-rays), viral load, IgG/IgM levels, and fecal
      microbiome will be evaluated at COVID-19 research center before randomization. Participants
      will be invited to remain at home and clinical evolution, temperature, SpO2 will be recorder
      and reported remotely during the 30 days intervention.

      On days 15 and 30, participants will be invited to return to COVID-19 research center to take
      samples to evaluate evolution of viral load, IgG/IgM and fecal microbiome.

      During the 30-days intervention period outcomes such as clinical progression, need of
      hospitalization, admission to Intensive Care Unit and death will be evaluated
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483; Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trials. 300 subjects (18-60 years old) will be allocated to receive a combination of Lactobacillus plantarum CECT 30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and P. acidilactici CECT 7483 (branch one) or placebo (branch two)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: probiotics; sars-cov-2; covid-19; adults