Changes in Viral Load in Patients With COVID-19 Disease After Dietary Supplementation With Probiotics: A Randomized Clinical Trial

1. Study hypothesis: Through the administration of specific probiotics, the immune response against the coronavirus COVID-19 could be stimulated, being able to decrease its viral load and secondary symptomatology.

There is a different way to attack a harmful microorganism. It is based on the existence in its habitat of a whole complex network of other microorganisms, our microbiota, which prevents the development, growth and feeding of that microorganism, either by competition of space, food, or immune effects. In COVID-19 patients, intestinal dysbiosis has been described, specifically observing the decrease of species considered as probiotics of the genera Lactobacillus and Bifidobacterium. The current study proposes the testing of the novel nutritional supplement to potential the patient's immune system and balances the damaged microbiota. This product contains species from the genera described as affected in the COVID-19 infection. Moreover, the strains selected showed an anti-inflammatory and antioxidant effect, and capacity for stimulation of the immune system in previous assays. All three strains have the GRAS status recognized by the FDA and are on the EFSA QPS list. The product also contains vitamin D, zinc and selenium, three powerful inducers of the immune response. It is a safe product according to WHO criteria. In addition, it can be effective despite the administration of antibiotics, due to postbiotic activity, reducing the risk of sepsis described in this type of patient. In order to monitor the effects of treatment with the functional product, a follow-up will be made by means of consultation regarding the evolution of the patient's condition. On the other hand, we will try to correlate this state with the viral load present in serum and pharyngeal-nasal scraping. 2. PRIMARY AND SECONDARY OBJECTIVES

Main objective: The main objective of the study is to evaluate the capacity of the novel nutritional supplement (immune system enhancer, antioxidant and anti-inflammatory capacity) to decrease the viral load by nasopharyngeal smear in patients admitted for COVID-19 coronavirus disease. The Patient will follow the medication agreed by the Hospital committee during all the process.

Secondary objectives: Monitoring of changes, in patients admitted by COVID-19+, of the following parameters at admission and prior to discharge:

• Hospital stay (days). Stay in Intensive Care Unit (days)
• Clinical indicators: Respiratory rate, body temperature, number of bowel movements and consistency. Abdominal pain. Nausea and vomiting. Sat02.
• Type of respiratory support on day 5 of admission: ambient air (none), nasal mask, ventimask, reservoir, non-invasive mechanical ventilation (NIV), orotracheal intubation.
• Analytical parameters at admission and discharge: Total lymphocytes, Hemoglobin, Ferritin, Neutrophils, Urea/Creatinine, C-reactive protein, LDH, D-dimer, AST/ALT, Platelets.
• Determination of the incidence of mortality in the patient cohort and comparison with that described in the literature.