Revisions for Post EUA study of Itolizumab in COVID-19 | Registro Público Cubano de Ensayos Clínicos

Current revision:

Post EUA study of Itolizumab 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.

Scientific title:

Observational study post Emergency Use Authorization (EUA) of the anti-CD6 monoclonal antibody itolizumab in the treatment of moderate, severe and critical patients with SARS-CoV-2 pneumonia (COVID-19)

Secondary indentifying numbers:

IIC RD-EC 180

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

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:

Trials notification

Regulatory instance:

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

Notification date :

23/09/2020

Reference number:

In process

Principal investigator

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

First name:

Carlos

Last name:

Hidalgo Mesa

Medical Specialty :

Second Degree Specialist in Internal Medicine

Affiliation:

"Comandante Manuel Fajardo Rivero" Military Hospital

Postal address:

Dos Gallardos corner Nueva, Cultural Complex “Abel Santamaria”, reparto Osvaldo Herrera

City:

Santa Clara

Country:

Cuba

Zip Code:

50100

Telephone:

+53-42206061

Email address:

carlitos.villaclara@gmail.com

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

Havana, Julio Trigo Hospital

Pinar del Rio, Leon Cuervo Rubio Hospital

Matanzas, Mario Munnoz Military Hospital

Matanzas, Faustino Perez Hospital

Camaguey, Octavio de la Concepcion Military Hospital

Holguin, Fermin Valdez Military Hospital

Holguin, Lucia Inniguez Hospital

Santiago de Cuba, Joaquin Castillo Duany Military Hospital

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

13/09/2020

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:

Pneumonia by SARS-CoV-2

Health condition(s) code:

COVID-19

SARS-CoV-2

Intervention(s):

Humanized monoclonal antibody Itolizumab: Treatment protocol for COVID-19 approved by MINSAP+ MAb Itolizumab. The patient will receive two doses of the MAb Itolizumab, 200 mg each, diluted to 200 mL of saline solution, separated by 72 hours, intravenously, with a slow infusion rate, not greater than 30 drops per minute, which means administer the product in approximately 2-3 hours.

Intervention code:

Antibodies, Monoclonal

Antibodies, Monoclonal, Humanized

Administration, Intravenous

Intervention keyword:

Itolizumab

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):

Reduction of lung function decline (Rate of patients without the need to increase FiO2 to maintain stable SO2 and without the need for intubation and/or Rate of patients with decreased positive end-expiratory pressure (PPEP) values) . Measurement time: 7 days

Key secondary outcomes:

1. Oro-tracheal intubation rate (Rate of patients requiring intubation). Measurement time: 7 days. 2. Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs, or failure of non-invasive mechanical ventilation (Rate of patients requiring non-invasive mechanical ventilation (NIMV), Rate of patients requiring invasive mechanical ventilation, Rate of patients with NIMV failure). Measurement time: before, 48, 72, 120 and 168 hours after administering itolizumab 3. Duration time of mechanical ventilation or time until weaning (Time elapsed from the start date of mechanical ventilation to the date of weaning ). Measurement time: until withdrawal of mechanical ventilation 4. Rate of deceased patients (proportion of deceased patients out of the total number of patients included 14 days after being included or once discharged from hospital). Measurement time: 14 days after treatment. 5. Serum concentrations of IL1, IL6 and TNF alpha (reported in pg/ml according to the reference values of the commercial kits used). Measurement time: at the beginning, 48, 96 and 168 hours after itolizumab administration. 6. HSH Score (Temperature, visceromegaly, cytopenias, triglycerides, fibrinogen, ferritin, AAT (TGO). Measurement time: 48, 96 and 168 hours after itolizumab administration. 7. C-reactive protein, and absolute count of lymphocytes (positive or negative, qualitative variable) Measurement time: pre, 48 hours, 72, 120 and 168 8. Adverse events related to treatment (according to causality and intensity) Measurement time: pre before administration of the antibody, during and after while the patient is hospitalized 9. Hospitalization time (days in hospital from the date of receiving treatment with Itolizumab until discharge or death in hospital) Measurement time: At discharge or death

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Any gender and skin color 2. Age equal to or greater than 18 years 3. SARS-CoV-2 infection diagnosed by RT-PCR or positive rapid test for COVID 19 4. Confirmed multifocal interstitial pneumonia 5. Need for oxygen therapy to maintain SO2>93% 6. Worsening of lung involvement, defined as one of the following criteria: o Worsening of oxygen saturation >3 percentage points • decrease in PaO2 >10%, • with stable FiO2 in the last 24h. • Need to increase FiO2 in order to maintain stable SO2 • new need for mechanical installation in the last 24 hours. • Increase in the number and/or extension of the pulmonary areas of consolidation. 7. Expresses the voluntariness of the patient, family member or impartial witness. 8. Alternatively, itolizumab may be used in patients in whom macrophage activation syndrome is suspected, according to the following criteria: • Need for oxygen therapy not less than 6L/min plus one of the following conditions: o Wheezing or gasping for breath (cannot quickly count to 20 after taking a deep breath). o Respiratory rate greater than 22 breaths per minute with oxygen therapy at 6L/min PO2. o Partial pressure of arterial oxygen <65 mm Hg. o Worsening of the radiological image. o Fever ≥38ºC. o Reduction of the initial values of hemoglobin, platelets or neutrophils or Hb<90 g/L, platelets<100 x109/L, neutrophils<1 x109/L or leukocytes <4 x109/L. o Decreased erythrocyte sedimentation rate in disagreement with CRP (low erythrocyte sedimentation rate and CRP increased or unchanged). o Increase in the initial value of triglycerides or triglycerides greater than 3 mmol/L. o Increase in the initial value of ferritin from 500 ng/ml or absolute value of ferritin ≥ 2000 ng/ml. o Transaminase aspartate-aminotransferase ≥30 IU/L. o Increased D-dimer o Fibrinogen < 2.5 g/L 9. Appearance of neurological manifestations

Exclusion criteria:

Pregnant or lactating women.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Observational

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

Open

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:

PhD. in Health Science. Biochemestry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15, Atabey, Playa

City:

Havana

Country:

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

Last Name:

Ramos Suzarte

Specialty:

PhD Health Science. Biochemestry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15. Atabey. Playa

City:

Havana

Country:

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:

Institute of Tropical Medicine "Pedro Kouri"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

27/03/2020

Postal address of Ethic Committee :

Autopista Novia del Mediodía 6 1/2 entre Autopista Nacional y Carretera Central CP. 11 400. La Habana. Cuba

Telephone:

+53-72020430 al 44

Email:

daniel@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

249

Study completion date:

30/04/2021

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:

RPCEC00000402

Date of Registration in Primary Registry:

21/03/2022

Record Verification Date:

2022/03/31

Next update date:

2023/03/31

Link to the spanish version:

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