COVID-19 prevention COVID-19 SARS-CoV2
Conditions
Interventions
Group I Biomodulin T (Experimental): Biomodulin T, 1 bulb (3mg / 3mL), twice a week, intramuscularly (IM) for 6 weeks. It will be applied to patients at higher risk of morbidity and mortality due to c
bedridden patients, individuals over 80 years of age, or clinical evidence of immunosuppression
Group II Biomodulin T (Experimental): Biomodulin T, 1 bulb (3mg / 3mL), once a week, intramuscularly (IM
Sponsors
Centro Nacional de Biopreparados (BioCen)
Not aplicable
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 60 years and over. 2. Any sex and skin color. 3. Patients who express their consent in writing, to participate in the study and in the event that 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 intercurrent illnesses including, but not limited to: acute infections with concomitant febrile symptoms, symptomatic congestive heart failure, unstable angina pectoris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: in each administration of the product up to 30 days after the last dose is administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. COVID-19 infection (incidence, occurrence of complications and mortality). Measurement time: 30 days after finished treatment. 2. Appetite improvement (Yes, No). Measurement time: 30 days after finished treatment. 3. Improvement of osteoarticular pain (Yes, No). Measurement time: 30 days after finished treatment. 4. Improvement of sleep disorders (Yes, No). Measurement time: 30 days after finished treatment. | — |
Countries
Cuba
Contacts
Public ContactLuis Heredia Guerra
Longevity, Aging and Health Research Center (CITED)
Outcome results
None listed