Preliminary results of the combined BlockACE2® Prevention and BlockACE2® functional food scheme for the prevention of COVID-19 in working population. Clinical trial , controlled, randomized, triple-blind, phase II.

Background: It is urgent to adopt public health measures and implement a preventive approach, its contagiousness and alleviate severe COVID-19, by reducing excessive inflammation.

Purpose: To establish the efficacy and safety of the combined use of BlockACE2® oropharyngeal spray, and emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19.

Methods: The clinical study includes 156 participants, ended with 125 adherent participants, 69 in the placebo group and 56 in the BlockACE2 group, with follow-up for 45 days. IgM seroconversion and confirmed with a RT-PCR test for COVID-19 were analyzed.

Results: the cases diagnosed in the placebo group were 5/64 = 0.078% and in the BlockACE2 group 1/55 = 0.018%. The practice of evidence-based medicine considers the randomized clinical trial as the standard to assess the efficacy of health technologies and recommends that decisions be made, with therapeutic options of proven efficacy. The recommended way to present the results of a randomized clinical trial and other types of study should include Relative risk reduction (RRR), Absolute Risk Reduction (RAR) and Necessary number of patients to treat to reduce an event (NNT). This way of presenting the results quantifies the effort to be made to achieve the reduction of an unfavorable event. Relative risk (RR) was 0.25, with a 95% CI (0.03 to 2.05) not statistically significant due to relatively small sample; however, other statistical measures from the clinical evidence were used, such as the Absolute Power, which was 0.753, which means that BlockACE2 could reduce the risk of coronavirus disease of any severity by 75.3%. The number needed to treat (NNT) is 18.31 people,

Conclusions: Due to its characteristics as a food that has no indication for the treatment of diseases as a medicine, or as a nutritional supplement, it requires a rigorous stance to guarantee the validity of the findings from the conduct of the research protocol. In this way, a clinically relevant finding, although “not statistically significant”, appears as a signal to scale models of clinical experimentation in the area, for new indications or new presentations. These natural support products could improve the immune conditions to neutralize the entry of the virus into the body and stimulate the cellular immune response to control the aggression of the virus, support and help control the pandemic in an efficient way.

Clinical Trials registry: NCT04420260


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