Potential of the Combination of a Systemic Enzyme Complex and Probiotics administration to Combat COVID-19: A Randomized Open Label Prospective Analysis

Abstract

Background: Enzymes have been used for therapeutic applications for decades owing to their anti-inflammatory and immunomodulatory effects. Probiotics are well known to reduce the incidence and severity of several health-related conditions. To our knowledge, no clinical trial has evaluated the effects of a combination of systemic enzyme and probiotic supplementation in Covid-19 patients infected with the SARSCoV-2 virus. Objective: We investigated the safety and efficacy of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) as supplemental therapy in confirmed mild to moderate COVID-19 patients. Methods: A randomized, open label, 2-arm, prospective study in patients with an RT-PCR confirmed diagnosis of COVID-19 with a mild to moderate condition was conducted. The control arm (n=30) received standard of care (SOC) treatment and the test arm (n=30) received the oral supplements ImmunoSEB (500 mg/cap.) + ProbioSEB CSC3 (5 billion CFUs /cap.) for 14 days in addition to SOC. The efficacy and safety of the experimental regimen was compared with the control arm at various timepoints from days 1 to 21. Results: A significantly higher proportion of patients in the test arm showed clinical improvement on day 10 vs the controls (93.33% vs 60%; p<0.05). No adverse events were reported in the test arm at any time during the study suggesting the safety of supplementation with ImmunoSEB + ProbioSEB CSC3. Patients in the test arm also had a shorter duration of hospitalization, quicker recovery and faster reduction in CRP levels as compared to the control arm. Conclusions: The present study concludes that supplemental therapy with ImmunoSEB + ProbioSEB CSC3 accelerates clinical improvement in mild to moderate COVID-19 patients. While there is no vaccine or specific drug to completely cure SARS CoV-2 infection, the proposed supplemental therapy could be a potential tool to aid in the recovery of COVID-19 of patients.