Prevention of infections including COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Biomodulin T, 1 bulb (3mg/3mL), 2 times per week, intramuscularly (IM) for 6 weeks.
Injections, Intramuscular
Sponsors
Centro Nacional de Biopreparados (BIOCEN)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria 2. Any sex and skin color aged 60 years and over. 3. Patients who express their consent in writing, to participate in the study and in case major cognitive impairment is present, be signed by a family member, tutor or caregiver.
Exclusion criteria
Exclusion criteria: 1. Patients who have received treatment with BIOMODULINA T® in the previous two months. 2. Patients with known hypersensitivity to any component of the formulation. 3. Patients with acute allergic states or history of severe allergic reactions. 4. Patients with uncontrolled breakthrough diseases including, but not limited to: acute infections with concomitant febrile illness, symptomatic congestive heart failure, unstable angina pectoris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory infections (Number (0 to infinity), Type (- High Respiratory, including a common cold, Sinusitis, Otitis, Laryngitis or Pharyngotonsillitis; - Low Respiratory such as Bronchitis, Bronchopneumonia), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for antibiotic treatment (Yes or No), Route of administration of antibiotic treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No). Measurement time: In the initial evaluation, in the monthly evaluation and final evaluation (6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infections from other systems (Number (0 to infinity), Type (Digestive, Skin and soft tissues, Genitourinary, CNS, SOMA, Generalized, Other), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for antibiotic treatment (Yes or No), Route of administration of antibiotic treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No). Measurement time: In the initial evaluation, in the monthly evaluation, and final evaluation (6 weeks). 2. COVID-19 infection (Occurrence (Yes or No), Complications (Yes or No) and Mortality (Yes or No)). Measurement time: In the evaluation per month and final evaluation (6 weeks). 3. Immunological Evaluation that will consist of Hemogram (Hemoglobin, Hematocrit, Leukogram with differential), Measurement time: In the initial and final evaluation; Lymphocyte subpopulations (CD3 + / CD4 +, CD3 + / CD8 +, CD19 + and CD3-CD56 +) and Igs Quantification (IgA, IgM and IgG) the immunological study will be measured: In the initial evaluation, one week after completing the treatment and final evaluation (6 weeks). 4. Adverse events-AE (Type (Name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Greater than one day), Previous knowledge (expected or unexpected), Intensity (mild , moderate or severe), Consequence (serious or not serious), Causation (Very probable / certain, Probable, Possible, Improbable, Not related, Not evaluable / not classifiable), Outcome of AD (Recovered, Not Recovered, Recovered with sequelae, Death or Unknown) and attitude towards the study treatment (Continuation or definitive interruption)). Measurement time: During all administrations of the product. In the evaluation per month, and final evaluation. In a sample of 30 randomly selected patients, from the “Alfredo Gomez Gendra” Nursing Home, it will be where the immunological parameters will be evaluated, before and after treatment, and their association w | — |
Countries
Cuba
Contacts
Public ContactLuis Heredia Guerra
Research Center on Longevity, Aging and Health (CITED)
Outcome results
None listed