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

Not Applicable

Recruiting

• Conditions: COVID-19; Coronaviridae Infections; Betacoronavirus; SARS-CoV2; Coronavirus Infections; SARS Virus; Disease Prevention; Aging

• Registration Number: RPCEC00000348
• Lead Sponsor: ational Center for Bioproducts (BioCen).

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-21
• Study Completion: 2023-09-21
• Results First Posted: 2023-11-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cellular immune response:<br>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.<br>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.