Nimotuzumab in COVID-19

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:

Scientific title:

Safety and efficacy study of the monoclonal antibody nimotuzumab in the treatment of severe patients with SARS-CoV-2 pneumonia. (COVID-19)

Acronym of Scientific Title:

NIMO COVID-19

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM), Cuban 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)

Reference number:

In process

Principal investigator

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

First name:

Henrry

Last name:

Diaz Londres

Medical Specialty :

Second Degree Specialist in Intensive Therapy

Affiliation:

Clinical Surgical Teaching Hospital "Julio Trigo Lopez"

Postal address:

Calzada de Bejucal No. km 7½, Reparto La Esperanza, Parraga, Arroyo Naranjo

City:

Havana

Country:

Cuba

Zip Code:

10900

Telephone:

+53-76438359

+53-55921867

Email address:

henrrydiaz@infomed.sld.cu [1]

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, Teaching Surgical Clinical Hospital "Dr. Salvador Allende", Jorge Jimenez Armada, MD., Second Degree Specialist in Intensive Therapy Specialist. Head of the COVID-19 Group of Experts

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

24/05/2021

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

Acute Disease

Critical Care

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Nimotuzumab (Experimental group): Nimotuzumab will be presented in bulbs of 50 mg / 10 mL, boxes of 4 bulbs. Up to three doses of Nimotuzumab will be administered by intravenous route (antecubital vein), the first two mandatory and, the third if there is no clinical improvement. First dose: 200 mg of Nimotuzumab diluted in 250 mL of 0.9% saline solution, (total volume of 290 mL), in a 2-hour infusion. Second dose: 100 mg of Nimotuzumab diluted in 250 mL of 0.9% saline solution, (total volume of 270 ml), in a 2-hour infusion. The second dose will be administered 72 hours after the first infusion. If the patient is still hospitalized in the Intensive Care Unit (ICU) and, shows signs of progressive disease, a third dose may be administered 72 hours after the second dose. The preparation of the infusion will be carried out in the same way as in the second administration.

Intervention code:

Antibodies, Monoclonal, Humanized

Antibodies, Monoclonal

Administration, Intravenous

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):

Safety 1. Serious Adverse Events-SAE (Percentage of patients who developed SAE according to the CTCAE v5.0 classification). Measurement time: During hospitalized time 2. Clinical and laboratory adverse events (The frequency distribution of AD appearance, type of event and body system will be determined. Duration, intensity, result, attitude and causal relationship of the AE will be identified. Measurement time: 0, 24, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days. Effect: 3. Rate of deceased patients in 14 days following the use of the drug. Measurement time: at 14 days 4. Rate of patients with disease progression (clinical or radiological worsening in the classification of clinical status). Measurement time: 0, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days.

Key secondary outcomes:

1. Pulmonary function (Rate of patients who improve the PO2/FiO2 ratio, Oro-tracheal intubation rate, measured as the rate of patients requiring intubation, Duration of mechanical ventilation or time to deteste, Chest X-ray). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days 2. Inflammation Markers (NLR, IL6, Interferon gamma, C-reactive protein). Measurement time: Day 0, at 72 hours, 120 and, 168 hours after the use of the drug. 3. Clinical Laboratory (Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrosedimentation, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate transferase, Pyruvic glutamic transferase, Complete Pyruvic Coagulogram, according the lab units). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days

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.- Any gender and skin color 2.- Age equal to or greater than 19 years 3.- Patients in a severe stage of COVID-19 of the disease defined by any of the following conditions: - Patients who have SpO2 <94% or patients in need of oxygen therapy to maintain SO2> 93% or - Patients with a PaO2 / FiO2 ratio <300 mm Hg or - Patients with a respiratory rate> 30 inspirations / min, - Patients with infiltrate in more than 50% of both lung fields

Exclusion criteria:

1.- Pregnant or lactating women. 2.-Under 19 years.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

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

Last Name:

Ramos Suzarte

Specialty:

Specialist in Biochemistry and Clinical Trials. Doctor of Health Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15. Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-7214 3146

Email :

mayra@cim.sld.u [2]

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

Last Name:

Ramos Suzarte

Specialty:

Specialist in Biochemistry and Clinical Trials. Doctor of Health Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15. Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-7214 3146

Email :

mayra@cim.sld.cu [3]

Research Ethics Committees

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

Name of Research Ethics Committees:

Teaching Surgical Clinical Hospital "Julio Trigo Lopez"

Teaching Surgical Clinical Hospital "Dr. Salvador Allende"

Status of evaluation:

Approved

In review

Status of evaluation date of Ethic Committee:

16/05/2021

15/05/2021

Postal address of Ethic Committee :

Calzada de Bejucal km 7½, Reparto La Esperanza, Parraga, Arroyo Naranjo, ZC 10900, Havana. Cuba

Calzada del Cerro 1551 corner Dominguez., Cerro, ZC 12000, Havana. Cuba

Telephone:

+53-76438359

+53-78776354

Email:

hosjtrigo@infomed.sld.cu

sallende@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/07/2021

Date of available results:

31/08/2021

Date of first publication:

30/09/2021

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:

RPCEC00000369

Date of Registration in Primary Registry:

21/05/2021

Record Verification Date:

2021/06/15

Next update date:

2022/06/15

Link to the spanish version:

Click here [4]