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BIOMODULINA T in a long-lived population at high risk of COVID-19 infection

Safety and effectiveness of BIOMODULINA T in a long-lived population at high risk of COVID-19 infection. Interventional Study (COVID-19)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000335
Enrollment
Unknown
Registered
2020-09-19
Start date
2020-09-26
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 prevention COVID-19 SARS-CoV2

Interventions

Biomodulina T, 1 bulb (3mg / 3mL), once a week, intramuscularly (IM) for 6 weeks.
Immunologic Factors
Injections Intramuscular
Biomodulin T

Sponsors

Centro Nacional de Biopreparados (BioCen)
Lead Sponsor
Not aplicable
Collaborator

Eligibility

Sex/Gender
All
Age
75 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 75 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

MeasureTime 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

MeasureTime 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 ContactLiliam Rodriguez Rivera

Longevity, Aging and Health Research Center (CITED)

liliamrodriguez@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026