Participant flow:
28 patients were enrolled in the study. But, the number of patients foreseen in the protocol were randomly included, 10 in the Study Group and 10 in the Control Group, for a total of 20. All the included patients finished the trial. No dropouts were recorded, nor did any patient develop discontinuation criteria. All patients underwent established tests and evaluations before the start and at the end of the study.
Baseline characteristics:
As for sex in the Study and Control Groups, the male predominated, constituting 80% and 70%, respectively. The difference found is not statistically significant (z=0.267; p=0.606). Half of the patients in both groups had black skin color, while 40% were white and the remaining 10% mestizo, differences that were not statistically significant (z=0.253; p=0.605). In the Study Group, the mean age of those included was 58.2 ± 7.4 years, while in the Control Group it was 49.5 ± 14.5 years. The difference observed from the statistical point of view is not significant (z=1.690; p=0.108).
In the Study Group, the mean weight was 73.05±12.8 kg, height 1.73±0.06 cm and body mass index (BMI) 24.5±4.3. Meanwhile, in the Control Group the mean weight was 67.5 ± 13.6 kg, height 1.68 ± 0.1 cm and BMI 23.7 ± 3.9. The differences observed in the initial evaluation were not statistically significant: intragroup height (z=1.171; p=0.293), intergroup height (z=1.170; p=0.292), intragroup weight (z=0.888; p=0.358), intergroup weight (z=0.880; p=0.356), intragroup BMI (z=0.153; p=0.701) and intergroup BMI (z=0.150; p=0.355). Therefore, the values recorded for height, weight and body mass index were comparable between both groups.
The individual nutritional evaluation was performed based on individual BMI values. In the Study Group, half (50%) were classified as overweight followed by normal weight (40%) and then underweight (10%). Meanwhile, in the Control Group, 60%, 30% and 10% were classified as normal weight, overweight and underweight, respectively. The same result of the nutritional evaluation was recorded in the final evaluation. Therefore, there were no differences regarding this parameter between the initial and final evaluations.
In the Study and Control Groups, according to personal pathological history, the most prevalent diseases were in this order: high blood pressure, cardiovascular disease, diabetes mellitus and polycystic kidneys. Hypertension was affecting all included patients (20 of 20) in both groups.
The distribution of patients according to smoking habits recorded a frequency of non-smokers of 70% in the Study Group and 90% in the Control Group. This reported difference was not statistically significant (z=1.250; p=0.264).
When describing the cause of chronic kidney disease in the patients of both groups, arterial hypertension and diabetes mellitus were found to be the most frequent causes. Among other causes, polycystic kidneys and the coincident presence of arterial hypertension and diabetes mellitus were reported. The differences between the groups were minimal and not significant (z=0.533; p=0.766).
In the Study Group, in all the patients the vascular access route for hemodialysis was the arteriovenous fistula (AVF). On the other hand, in most of the patients in the Control Group it was this same vascular access route and only one patient had access through a central venous catheter (CVC). 90% (19 of 20) of the patients included in the study had vascular access due to arteriovenous fistula. The observed difference was not significant (z=1.500; p=0.305)
In the patients of the Study Group, according to the time in years elapsed since the start of hemodialysis until inclusion, in 2 less than one year had elapsed; in 3 more than one year but less than three years; in 2 more than three years but less than five years; and finally in 3 more than five years. Meanwhile, in the Control Group, in 2 less than a year had elapsed; in 5 more than one year but less than three years; and in three more than five years. Although changes were observed in the time spent on hemodialysis, the differences were not significant (z=2.500; p=0.475).
Summary study:
Treatment with Biomodulina T® stimulates the immune response and decreases respiratory infections in older adults. Its effect and safety in patients with Chronic Kidney Disease is stage 5 in iterated hemodialysis regimen (CKD-5 in HdI) were unknown. The purpose of this study was to evaluate the effect and safety of Biomodulina T® for the stimulation of the immune response in patients with CKD-5 in LHD, from a preventive scenario against the viral disease COVID-19. An exploratory, multicenter, open, controlled, randomized clinical trial was conducted. The study was carried out in 20 patients attended in the outpatient hemodialysis service of the Hospital Hermanos Ameijeiras with a diagnosis of CKD-5 in LHD, over 18 years of age, who gave their written consent and met the selection criteria, who were randomized 1 :1 (Group 1 or study 10 patients and Group 2 or control 10 patients). Patients with acute allergic states or a history of severe allergic reactions, patients with primary or secondary glomerulopathies, patients with hemoglobin less than 99 g/L, and patients with uncontrolled intercurrent diseases such as: acute infections with concomitant febrile symptoms, heart failure were excluded. symptomatic congestive and unstable angina pectoris. The patients in the Study Group received Biomodulina T® in a scheme of 1bbo (3mg) IM twice a week for 6 weeks and those in the control group did not receive this treatment. To determine the behavior of cellular (lymphocyte subpopulations) and humoral (Immunoglobulins and Complement) immunological parameters, all study patients underwent blood draws for the initial evaluation (T0), and a second and final draw (T7). which corresponded to one week after finishing the treatment in the case of the patients in the study group. All patients were followed up for a period of 8 weeks, determining at this time: the changes in relation to infections with the 8 weeks prior to starting treatment, the incidence of COVID-19 and the safety of the product under investigation when identifying and classifying the adverse events that occurred in the patients, during the course of the study. In both groups, male sex and black skin color prevailed. Meanwhile, in the Study Group the mean age was 58.2 ± 7.4 years and in the Control Group 49.5 ± 14.5 years. Due to the characteristics described, the demographic variables are homogeneous and comparable. A total of 120 intravenous applications (360 mg) were administered, 100% of those planned. In patients with CKD-5 in LHD, according to cellular and humoral immunological parameters in both groups, inflammation predominates over immunosuppression. Treatment with Biomodulin T showed evidence of its influence in slowing down the decline in naïve T lymphocytes and the progression of inflammation in treated patients. A low incidence of infections was evidenced, but the short evaluation time before and after treatment prevents an adequate weighting in terms of infections in both study groups. During the study, none of the patients was diagnosed with COVID-19, neither those in the control group nor those in the treatment group, therefore this effect cannot be attributed solely to Biomodulina T. 5. The administration of intravenous Biomodulina T® was safe and well tolerated by patients, with very few related adverse events appearing, none of which caused treatment interruption. Treatment with Biomodulina T® had a lower therapeutic effect than expected, although it maintained a narrow safety profile, which is why it is suggested that other studies be carried out exploring other dose schedules, longer evaluation times and a larger sample of patients.
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