Nimotuzumab in the treatment of patients with acute respiratory difficulty syndrome (ARDS)

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

Scientific title:

Safety evaluation and preliminary effect of the monoclonal antibody Nimotuzumab in the treatment of patients with acute respiratory distress syndrome (ARDS)

Secondary indentifying numbers:

Not aplicable

Issuing authority of the secondary identifying numbers:

Not aplicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) , Ministry of Public Health of Cuba(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)

Principal investigator

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

First name:

Anselmo

Midle name:

Antonio

Last name:

Abdo Cuza

Medical Specialty :

Intensive Therapy Second Dedree Specialist

Affiliation:

Center of Medical Surgical Research (CIMEQ)

Postal address:

Calle 216 y 11-B, Reparto Siboney

City:

Havana

País:

Cuba

Zip Code:

12100

Telephone:

+53-78581000

Email address:

aaabdo@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:

Havana, Salvador Allende Hospital, PhD Jorge Jimenez Armada, 2dn degree Intensive Care Especialist

Matanzas, Comandante Faustino Perez Hospital, PhD Hisyovi Cardenas Surí, 2dn degree Intensive Care Especialist

Villa Clara, Arnaldo Milian Hospital, PhD Armando David Caballero Font, 2dn degree Intensive Care Especialist

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

13/03/2023

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:

Acute respiratory distress syndrome (ARDS)

Health condition(s) code:

Respiratory Distress Syndrome

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Intervention(s):

Group I (Experimental) MAb Nimotuzumab, 200 mg the first dose followed by 100 mg doses separated by 72 hours, up to a total of 5 maximum. It will be administered intravenously. This group also receives established therapy in the ICU to control ARDS. Group II (Control) will receive the therapy established in the ICU to control the ARDS. The maximum duration of treatment will be 12 days.

Intervention code:

Anticuerpos Monoclonales Humanizados

Anticuerpos Monoclonales

Administración Intravenosa

Intervention keyword:

Nimotuzumab

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):

Adverse Events (AE). Measurement time: daily until discharge. - Occurrence of some AE in the subject (yes/no). - Description of the AE (Name of the adverse event). - Duration of the EA (Difference of dates between the beginning and the end of the event) - Intensity of the AE (Mild, Moderate, Severe) - AE severity (Serious/serious, Not serious/not serious) - Attitude regarding study treatment (no changes, dose modification, temporary or permanent interruption of study treatment) - Result of the EA (recovered, improved, persists or sequelae) -Causal relationship (1.Very Likely, 2.Likely, 3.Possible, 4.Improbable, 5.Not related, 6.Not evaluable)

Key secondary outcomes:

Pulmonary function. Measurement time: daily until discharge • Rate of patients who improve the PO2/FiO2 ratio. • Duration time of mechanical ventilation or time until weaning (Date difference between start and end of ventilation). • Chest X-ray or Ultrasound according to the criteria established in intensive care. The same follow-up imaging method will be used. • Ventilation-free days up to 28 days (Difference of days between start and finish without ventilation). • Recovery rate (alive) at ICU discharge. • Overall recovery rate (28 days) • Inflammation Markers: NLR, IL6, C-reactive protein: Measurement time: day 0, and every 48 hours after the use of the drug. • Clinical Laboratory Exams: Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrocyte sedimentation rate, C-Reactive Protein, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate Transferase, Glutamic Pyruvic Transferase, coagulogram including PAI-1 .

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

none

Inclusion criteria:

1. Mild or moderate ARDS, with subpulmonary or extrapulmonary phenotype. 2. Any gender and skin color 3. Age equal to or greater than 19 years 4. Patients with signed informed consent

Exclusion criteria:

1 Pregnancy or breastfeeding. 2. History of known HIV, hepatitis B or C infection (referred by the patient or their representative). 3 Known allergy or hypersensitivity to any component of the formulation under study. 4. Minimal probability of survival and a life expectancy of less than 3-5 days as defined by an APACHE II score of ≥ 35 at enrollment. 5 Be receiving another investigational product.

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:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

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:

Mayra

Middle Name:

Ramos

Last Name:

Suzarte

Specialty:

Biochemestry, PhD in Health Science

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 16. Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@cim.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:

Mayra

Middle Name:

Ramos

Last Name:

Suzarte

Specialty:

Biochemestry. PhD

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15. Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72143146

Email :

mayra@cim.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Medical Surgical Research Center

Salvador Allende Clinical Surgical Teaching Hospital

Comandante Faustino Perez Hospital

Arnaldo Milian Castro Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/10/2022

21/11/2022

30/10/2022

02/11/2022

Postal address of Ethic Committee :

Calle 216 y 11 B. Siboney. Playa. Havana. Cuba

Calzada del Cerro 1551 esq. Dominguez. CP. 12000 , Havana. Cuba

Carretera Central Km. 101. CP. 40100 Matanzas, Cuba

Avenida Arnaldo Milian Castro e/ Circunvalación y Doble Vía. CP. 50100, Villa Clara, Cuba

Telephone:

+53-78581000

+53-78776354

+53-45256001

+53-42270033

Correo electrónico:

bcimeq@infomed.sld.cu

sallende@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/07/2023

Date of available results:

31/01/2024

Date of first publication:

28/02/2024

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:

RPCEC00000418

Date of Registration in Primary Registry:

03/03/2023

Record Verification Date:

2023/03/03

Next update date:

2024/03/03

Link to the spanish version:

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Nimotuzumab in the treatment of patients with acute respiratory difficulty syndrome (ARDS)

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