Biomodulin T-IM-oncological adults post chemotherapy-prevention COVID-19. Exploratory study

Evaluation of the effect and safety of Biomodulin® T on the immune response in post-chemotherapy cancer patients, from a preventive scenario against the COVID-19 viral disease. Exploratory study (COVID-19) - ONCOBIO-T

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000348

Enrollment

Registered

2020-12-21

Start date

2021-04-22

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 COVID-19 SARS-CoV2

Interventions

Biomodulin T, 1 bulb (3mg / 3mL), 2 times a week, intramuscularly (IM) for 8 weeks.

Immunologic Factors

Injections Intramuscular

Biomodulin T

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients 65 years and over. 2. Patients subject to treatment with adjuvant or metastatic CT with finite treatment. 3. Tributary patients to chemotherapy schemes according to the Chemotoxicity scale. 4. Patients with a life expectancy equal to or greater than 6 months. 5. Patients who express, in writing, their consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with tumors of the hemolymphopoietic system. 2. Patients with criteria for radiotherapy treatment. 3. Patients receiving treatment with another research product. 4. Patients receiving Immunotherapy treatment (except for colony stimulating factors). 5. Patients with known hypersensitivity to any component of the Biomodulin® T formulation. 6. Patients with decompensated intercurrent illnesses, including: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, kidney or liver disease, or other pathology that medically affects the patient's participation in the study. 7. Patient with psychiatric or neurotic diseases or memory loss that could limit adherence to the clinical trial. 8. Patients with human immunodeficiency virus (HIV).

Design outcomes

Primary

Measure	Time frame
Cellular immune response: 1. Lymphocyte populations (CD4 T (CD3 +/CD4 +), CD8 T (CD3+/CD8+) and B (CD19 +) assessed by flow cytometry). Measurement time: At baseline, between 1 to 14 days after evaluation of response to treatment with Chemotherapy (CH), at the start of treatment with Biomodulin® T (BMT), between 7 to 14 days after the end of treatment with BMT and, 8 weeks after the end of treatment with BMT. 2. Neutrophil/Lymphocyte index (Values assessed by hemogram determination). Measurement time: At baseline, between 1 to 14 days after evaluation of the response to treatment with CH, at the start of treatment with Biomodulin® T (BMT), between 7 to 14 days after after completion of BMT treatment and, 8 weeks after the end of BMT treatment.	—

Measure

Time frame

Cellular immune response: 1. Lymphocyte populations (CD4 T (CD3 +/CD4 +), CD8 T (CD3+/CD8+) and B (CD19 +) assessed by flow cytometry). Measurement time: At baseline, between 1 to 14 days after evaluation of response to treatment with Chemotherapy (CH), at the start of treatment with Biomodulin® T (BMT), between 7 to 14 days after the end of treatment with BMT and, 8 weeks after the end of treatment with BMT. 2. Neutrophil/Lymphocyte index (Values assessed by hemogram determination). Measurement time: At baseline, between 1 to 14 days after evaluation of the response to treatment with CH, at the start of treatment with Biomodulin® T (BMT), between 7 to 14 days after after completion of BMT treatment and, 8 weeks after the end of BMT treatment.

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Secondary

Measure	Time frame
1. Infections during the study: a.Respiratory infections ((Number (0-infinity), Type (1-Upper Respiratory like common cold, sinusitis, otitis, laryngitis or pharyngotonsillitis, 2-Lower Respiratory like bronchitis or bronchopneumonia), Etiology (Bacterial, Viral, Fungal, Parasitic ), Need for antibiotic / antiviral treatment (Yes, No), Route of administration of antibiotic / antiviral treatment (Oral, Parenteral), Need for hospital admission (Yes, No) and Mortality from infection (Yes, No)). Measurement time: Between 1 to 14 days after the evaluation of the response to treatment with QT, at the beginning of treatment with Biomodulin® T (BMT), between 7 to 14 days after the end of treatment with BMT and 8 weeks after the end of the treatment with BMT. b. Infections from other systems (They will be classified according to Number (0 to infinity), Type (Digestive, Skin and soft tissues, Genitourinary, CNS, SOMA, Generalized, Other), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for Antibiotic / antiviral treatment (Yes or No), Route of administration of antibiotic / antiviral treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No)). Measurement time: Between 1 to 14 days after the evaluation of the response to treatment with QT, at the beginning of treatment with Biomodulin® T (BMT), between 7 to 14 days after the completion of treatment with BMT and 8 weeks after the end of BMT treatment. c. COVID-19 infection ((Occurrence (Yes or No), Complications (Yes or No) and Mortality (Yes or No)). Measurement time: Between 1 to 14 days after the evaluation of the response to treatment with CH, at the beginning of treatment with Biomodulin® T (BMT), between 7 to 14 days after the completion of treatment with BMT and 8 weeks after the end of BMT treatment. 2. Adverse Events-AE (According to Type (name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Grea	—

Measure

Time frame

1. Infections during the study: a.Respiratory infections ((Number (0-infinity), Type (1-Upper Respiratory like common cold, sinusitis, otitis, laryngitis or pharyngotonsillitis, 2-Lower Respiratory like bronchitis or bronchopneumonia), Etiology (Bacterial, Viral, Fungal, Parasitic ), Need for antibiotic / antiviral treatment (Yes, No), Route of administration of antibiotic / antiviral treatment (Oral, Parenteral), Need for hospital admission (Yes, No) and Mortality from infection (Yes, No)). Measurement time: Between 1 to 14 days after the evaluation of the response to treatment with QT, at the beginning of treatment with Biomodulin® T (BMT), between 7 to 14 days after the end of treatment with BMT and 8 weeks after the end of the treatment with BMT. b. Infections from other systems (They will be classified according to Number (0 to infinity), Type (Digestive, Skin and soft tissues, Genitourinary, CNS, SOMA, Generalized, Other), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for Antibiotic / antiviral treatment (Yes or No), Route of administration of antibiotic / antiviral treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No)). Measurement time: Between 1 to 14 days after the evaluation of the response to treatment with QT, at the beginning of treatment with Biomodulin® T (BMT), between 7 to 14 days after the completion of treatment with BMT and 8 weeks after the end of BMT treatment. c. COVID-19 infection ((Occurrence (Yes or No), Complications (Yes or No) and Mortality (Yes or No)). Measurement time: Between 1 to 14 days after the evaluation of the response to treatment with CH, at the beginning of treatment with Biomodulin® T (BMT), between 7 to 14 days after the completion of treatment with BMT and 8 weeks after the end of BMT treatment. 2. Adverse Events-AE (According to Type (name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Grea

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Countries

Cuba

Contacts

Public ContactMaria Arango Prado

National Institute of Oncology and Radiobiology (INOR)

carmenap@infomed.sld.cu.

Outcome results

None listed

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