A randomized, double-blind, clinical study to evaluate the effect of Spectramune in mild to moderate COVID-19 subjects

Citation: A randomized, double-blind, clinical study to evaluate the effect of [Spectramune] in mild to moderate COVID-19 subjects [data on file]

Abstract:

A randomized, double-blind, placebo-controlled, parallel group study assessed the effects of Spectramune in male and female subjects aged between 20-60 years with body mass index (BMI) of 22-29.9 kg/m2, in hospital isolation, confirmed as positive for Laboratory (RT-PCR) SARS-CoV-2. Subjects with symptoms of mild illness with COVID-19 that include any of the following symptoms: fever, sore throat, cough, malaise, headache, muscle pain, gastrointestinal symptoms. Subjects with symptoms of moderate illness with COVID-19 that include mild illness or shortness of breath with exertion or any of the following clinical signs.

Efficacy variables were time duration till clinical recovery including RT-PCR, SF-36, IFQ, biomarkers (IL-6, TNF-α and IFN-γ in serum), hematology parameters. Safety was evaluated by monitoring vital signs, blood chemistry profile, frequency, the severity of adverse events. Efficacy was based primarily on the mean time taken to recovery, as assessed by the improvement of COVID 19 symptoms and a negative RT-PCR report. There was a change from baseline to end of trial period in vitals, hematology and biochemistry parameters, lipid profile and serum biomarkers.

A statistically significant difference in average time taken to recover from covid-19 symptoms was observed in [Spectramune]-supplemented groups when compared to placebo. Subjects in [Spectramune] groups recovered 8.27 days and 6.46 days earlier than subjects in placebo cohort. Compared to placebo, a significant improvement in immune function was observed in both treatment groups by the end of the study. Similarly, quality of life of the participants in supplement groups also improved to a significant extent compared to baseline and placebo.

At the end of the supplementation period, mean change in CD4 count observed was significantly improved compared to baseline. This improvement is higher in CL20193 group compared to placebo. Haematology, biochemistry and lipid profile parameters were significantly improved within each group from baseline to end of the study. Improvements in haematology parameters like ESR and TLC were clinically significant in three study arms. Overall, these observations strengthen the rationale for use of [Spectramune] in the management of mild to moderate COVID 19 patients.