Biomodulina T - IM- covid-19 - older adultos - Phase IV clinical trial

Evaluation of the safety and efficacy of BIOMODULINA T® for the prevention of infections, including COVID-19, in older adults in Cuba. Phase IV clinical trial (COVID-19) - GEC2020BMT024

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

RPCEC

Registry ID

RPCEC00000310

Enrollment

Unknown

Registered

2020-05-05

Start date

2020-04-03

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

Prevention of infections, including covid-19 Covid-19 SARS-CoV2

Interventions

Group I: Biomodulina T, 1 bulb twice a week by intramuscular route (IM) for 6 weeks. The treatment will apply to the patients with the highest risk of morbidity and mortality due to chronic cardiovasc

Immunologic Factors

Injections, Intramuscular

Biomodulin T

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 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
Adverse Events-AE (The AE will be classified according to Type, Location, Time of appearance, Duration, Previous knowledge, Intensity, Consequence, Causality, Result and, attitude regarding the study treatment). Measurement time: In each administration of the product and, 30 days after the last dose of the product was administered.	—

Secondary

Measure	Time frame
A) Clinical response variables 1. COVID-19 infection (incidence, occurrence of complications and mortality) Measurement time: one month after the end of treatment; 6 months and, one year after starting treatment. 2. Infections: Number, Type (depending on the organ or system affected), Need for antibiotic treatment, Route of administration of antibiotic treatment, Need for hospital admission, Mortality. Measurement time: initial evaluation (up to 1 year before), in the evaluation one month after the treatment; 6 months and one year after starting treatment.	—

Measure

Time frame

A) Clinical response variables 1. COVID-19 infection (incidence, occurrence of complications and mortality) Measurement time: one month after the end of treatment; 6 months and, one year after starting treatment. 2. Infections: Number, Type (depending on the organ or system affected), Need for antibiotic treatment, Route of administration of antibiotic treatment, Need for hospital admission, Mortality. Measurement time: initial evaluation (up to 1 year before), in the evaluation one month after the treatment; 6 months and one year after starting treatment.

—

Countries

Cuba

Contacts

Public ContactLilliams Rodriguez Rivera

Research Center on Longevity, Aging and Health (CITED)

liliamrodriguez@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026