A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActive(TM)) for COVID-19 Patients

BACKGROUND: SARS-CoV-2 has emerged as a global threat due to its infectivity and rapid transmission. We evaluated the safety and efficacy of herbal and mineral formulation (ImmuActive) as an adjunct therapy in COVID-19 patients. METHODS: A randomized, double-blind, placebo-controlled study was conducted in 100 COVID-19 patients in three centers in Southern India, and 92 subjects completed the study. Subjects were followed up until they were discharged from the hospital or for a maximum of 28 days, whichever was earlier. The primary outcome parameters were the mean change and time required to change the ordinal scale of disease severity by one unit. The secondary outcomes were the time required to turn RT-PCR negative or get discharged from the hospital, change in modified Jackson's Symptom Severity score, and COVID-19 quality of life questionnaire. RESULTS: The ordinal scale at the end of the study was significantly lower in COVID-19 patients supplemented with ImmuActive (0.57) than placebo (1.0), with a p value of 0.0043. The ordinal scale decreased by one unit within 2.35 days in ImmuActive-supplemented patients, while it took 3.36 days in placebo-supplemented patients. Days of hospitalization and time required to turn RT-PCR negative were comparatively lower in the ImmuActive arm than the placebo arm. Change in modified Jackson's Symptom Severity Score and COVID-19 QOL were significant from screening to the end of the study in both ImmuActive and placebo arms. There were no adverse events observed during the study period. CONCLUSION: The study results suggest that ImmuActive could be a beneficial and safe adjunct treatment for effectively managing COVID-19 infection symptoms.