Open Label, Evaluation of the effects of the uncontrolled use of Biomodulina T on the severity of SARS-CoV-2 infections in older Cuban Adults.

Background: The ongoing 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 the ageing of the immune system. Biomodulina T® is an injectable immune modulator that has been licensed for use in Cuba for many years. An open-label, uncontrolled trial was conducted to investigate whether it might be useful to prevent or modulate the serious effects of SARS-CoV-2 infections in older Cuban adults prior to the availability of vaccinations.

Methods: From April 12 to August 31, 2021, 1239 adults, sixty years and older, unvaccinated against COVID-19 were recruited from the José Luis Dubrocq polyclinics, to receive Biomodulina T®, one intramuscular 3 ml dose weekly for 6 weeks. Each person was visited at home weekly to be given Biomodulina T®. Once daily subjects 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 post-treatment observation period.

Results: Sixteen subjects were diagnosed with symptomatic COVID-19 during the intervention using a specific RT-PCR. One subject died because of COVID-19. The most common pre-existing diagnoses in treated subjects 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 subjects than what was observed in the untreated general population of this Cuban province during the same time period.

Conclusion: While 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 SARS-CoV-2 infections in these older Cuban adults.