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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ONCOBIO-T

Scientific title:

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)

Acronym of Scientific Title:

ONCOBIO-T

Secondary indentifying numbers:

GEC2020BMT030

Issuing authority of the secondary identifying numbers:

National Center for Bioproducts (BioCen).

Source(s) of monetary or material support:

National Center for Bioproducts (BioCen). Ministry of Public Health (Minsap)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

30/12/2020

Reference number:

543/05.020.20BNV

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria

Midle name:

del Carmen

Last name:

Arango Prado

Medical Specialty :

Second Degree Specialist in Immunology, PhD.

Affiliation:

National Institute of Oncology and Radiobiology (INOR). Department of Basic Research, Immunology Laboratory

Postal address:

710 F Street between 29 and Final

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78388663

Email address:

carmenap@infomed.sld.cu.

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not Applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

22/04/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

COVID-19

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Disease Prevention

Aging

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

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

Intervention code:

Immunologic Factors

Injections Intramuscular

Intervention keyword:

Biomodulin T

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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 Greater than one day), Prior knowledge (expected or unexpected ), Intensity (mild, moderate or severe), Consequence (serious or not serious), Causation (Highly probable / certain, Probable, Possible, Unlikely, Not related, Not evaluable / not classifiable), Outcome of AE (Recovered, Not Recovered , Recovered with sequelae, Death or Unknown) and attitude towards study treatment (Continuation or definitive interruption)). Measurement time: Between 1 to 14 days after 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 the BMT treatment and 8 weeks after the end of the BMT treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

65 years

Maximum age:

None

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).

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

60

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maria

Middle Name:

del Carmen

Last Name:

Arango Prado

Specialty:

Second Degree Specialist in Immunology, PhD., Department of Basic Research, Immunology Laboratory

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal Address:

710 F Street between 29 and Final

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78388663

Email :

carmenap@infomed.sld.cu.

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Suset

Last Name:

Rodríguez Chávez

Specialty:

Bachelor of Pharmaceutical Sciences

Affiliation:

National Center of Bioproducts (BioCen)

Postal Address:

Carretera de Beltran km 1 1/2

City:

Mayabeque

País:

Cuba

Zip Code:

13050, P.O. Box 6048

Telephone:

+53-47682441

Email :

suset.rdguez@biocen.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Institute of Oncology and Radiobiology (INOR)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

16/12/2020

Postal address of Ethic Committee :

F # 710 e/ 29 and Final, Plaza, Havana, PB:10400, Cuba

Telephone:

+53-78388663

Correo electrónico:

ichoninor@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

11/07/2023

Date of available results:

21/09/2023

Date of first publication:

21/11/2023

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000348

Date of Registration in Primary Registry:

21/12/2020

Record Verification Date:

2022/10/27

Next update date:

2023/10/27

Link to the spanish version:

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

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