The Effects of the Uncontrolled Use of Biomodulina T on the Severity of Severe Acute Respiratory Syndrome-Coronavirus 2 Infection in Older Cuban Adults: An Open Label Evaluation

Abstract

BackgroundThe ongoing coronavirus disease 2019 (COVID-19) pandemic is a worldwide public health threat. Millions of people are at risk and older adults are more susceptible to developing the most serious manifestations of the disease, in part because of the effects of ageing on the immune system. Biomodulina T is an injectable immune modulator that has been licensed for use in Cuba for many years.ObjectiveAn open-label, uncontrolled trial was conducted to investigate whether or not it might be useful to prevent or modulate the serious effects of severe acute respiratory syndrome coronavirus 2 infections in older Cuban adults before the availability of vaccinations.MethodsFrom April 12 to August 31, 2021, 1239 adults aged 60 years and older, unvaccinated against COVID-19 were recruited from the José Luis Dubrocq polyclinics, to receive Biomodulina T, 1 intramuscular 3 mL dose weekly for 6 weeks. Each person was visited at home weekly to be administered Biomodulina T. Once daily patients were seen by a medical student to collect information on any possible adverse events related to the medication as well as any symptoms of COVID-19. The possible usefulness of the intervention and its potential adverse events were assessed based on the number of older adults who became infected with COVID-19, and the severity of any symptoms reported or noted both during the 6-week treatment period and during an additional 6-week posttreatment observation period.ResultsSixteen patients were diagnosed with symptomatic COVID-19 during the intervention using a specific reverse transcription polymerase chain reaction test. One patient died because of COVID-19. The most common preexisting diagnoses in treated patients included high blood pressure in 64.8%, diabetes mellitus in 19.85%, and ischemic cardiopathy in 13.88%. Biomodulina T was well tolerated. Only infrequent, mild, transient, and self-limited adverse events were identified. Both the incidence of COVID-19 infections and the overall mortality rate were lower in the treated patients than what was observed in the untreated general population of this Cuban province during the same time period.ConclusionsAlthough further, confirmatory, double-blind, controlled clinical trials are needed, Biomodulina T injections were well tolerated, and the results of this open, uncontrolled study suggest that it may have been useful to decrease the incidence and severity of symptomatic COVID-19 infection in these older Cuban adults. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc