Treatment of SARS CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab

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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:

VICTORIA

Scientific title:

Treatment of patients with severe SARS-CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab. (COVID-19)

Acronym of Scientific Title:

VICTORIA

Secondary indentifying numbers:

IIC RD-EC 179

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology and 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 :

04/05/2020

Reference number:

In process

Principal investigator

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

First name:

Armando

Last name:

Caballero Lopez

Medical Specialty :

Medical Doctor I and II degree in Especialista de 1er grado en Anestesiology and reanimation

Affiliation:

Hospital Universitario Arnaldo Milian Castro.

Postal address:

Avenida “Arnaldo Milian Castro” e/ Circunvalacion y Doble Via, Santa Clara

City:

Villa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-42270000

Email address:

caballerol@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:

Villa Clara, Hospital Militar Manuel Piti Fajardo

Havana, Instituto Medicina Tropical Pedro Kouri

Havana, Hospital Salvador Allende

Matanzas, Hospital Militar Mario Muñoz

Havana, Hospital Ortopédico Frank Pais

Pinar del Rio, Hospital Leon Cuervo Rubio

Havana, Hospital Julio Trigo

Matanzas, Faustino Perez

Camaguey, Hospital Militar Octavio de la Concepción de La Pedraja

Holguin, Hospital Militar Fermin Valdes Dominguez

Las Tunas, Hospital Ernesto Guevara de la Serna

Santiago de Cuba, Hospital Militar Joaquín Castillo Duany

Santiago de Cuba, Hospital Juan Bruno Zayas

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

28/03/2020

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:

severe SARS-CoV-2 pneumonia

Intervention(s):

TREATMENT SCHEME • An intravenous dose of 200 mg (8 vials of itolizumab) will be administered once the inclusion criteria are met. • A second dose, after 72 hours, will be administered if the patient still has signs of respiratory failure or macrophage activation syndrome. The treatment will be administered concomitant with the protocol tretaments approved by Ministry of Public Health

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 deterioration of lung function (Patient rate without the need to increase FiO2 to keep SO2 stable and without the need for intubation and(or); Rate of patients decreasing positive pressure values at the end of exhalation (PPFE)). Measurement time: 7 days.

Key secondary outcomes:

1. Endo-tracheal intubation rate (rate of patients needing intubation). Measurement time: 7 days. 2. Non-invasive or invasive mechanical ventilation rate when respiratory failure occurs, or non-invasive mechanical ventilation failure (Rate of patients who need non-invasive mechanical ventilation (NIMV), Rate of patients who need invasive mechanical ventilation, Rate of patients with NIMV failure). Measurement time: At baseline and, at 48, 72, 120 and 168 hours of itolizumab administration. 3. Time of duration of mechanical ventilation or time to end of mechanical (Time from the start date of mechanical ventilation to the weaning date). Measurement time: Until mechanical ventilation is retired 4. Rate of patients deceased (proportion of patients deceased of the total of included patient within 14 days or once the hospitalary discharge is given). Measurement time: 14 days after use of the medicinal product. 5. Serum concentrations of IL1, IL6 and TNF alfa (in pg/ml according to the reference values of the commercial kits). Measurement time: At baseline and, at 48, 96 and 168 hours of itolizumab administration. 6.HSH score parameters (Temperature, visceromegaly, cytopenia, triglycerides, fibrinogen, ferritin, AAT (GOT)). Measurement time: at 48, 96 and 168 hours of itolizumab administration. 7. C-reactive protein, and absolute lymphocyte count (positive or negative). Measurement time: At baseline and, at 48, 72, 120 and 168 hours of itolizumab administration. 8. Adverse events related to treatment (according to the causality relationship and intensity. Measurement time: At before the administration of the antibody, during the administration and while the patient is hospitalized. 9. Hospitalization time (days in hospital from time to Itolizumab administration until hospitalary discharge or deceased). Measurement time: At the hospitalary discharge or deceased.

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 old

Maximum age:

none

Inclusion criteria:

• Any gender and skin color • Age equal to or greater than 18 years • SARS-CoV2 infection diagnosed by PCR-RT or rapid test to the COVID 19 positive • Confirmed Multifocal interstitial pneumonia • Need for oxygen therapy to maintain saturation of O2>93% • Worsening of lung involvement, defined as one of the following criteria: o Worsening oxygen saturation >3 percentage points or decrease in PaO2 >10%, with FiO2 stable in the last 24 hours. o Need to increase FiO2 in order to maintain a stable SO2 or new need for mechanical installation in the last 24 hrs. o Increase in the number and/or extent of consolidation lung areas • Express willfulness of the patient, family member or impartial witness Alternatively, itolizumab may be used in patients suspecting macrophage activation syndrome, according to the following criteria: Need for oxygen therapy not less than 6L/min plus one of the following conditions: • Wheezing or irregular speech (cannot quickly count to 20 after deep inspiration) • Respiratory frequency greater than 22 breaths per minute with oxygen therapy at 6L/min • PO2: Partial arterial oxygen pressure <65 mm Hg • Worsening of the radiological image • Fever ≥ 38oC • Reduction of 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. • Decreased erythrocyte sedimentation in mismatch with PCR (low erythrocyte sedimentation and PCR increases or does not change) • Increased initial value of triglycerides or triglycerides greater than 3 mmol/L. • Increased initial ferritin value from 500 ng/ml or absolute ferritin value ≥ 2000 ng/ml. • Transaminase aspartate-aminotransferase ≥30 IU/L • Increase in dimer D • Fibrinogen < 2.5 g/L • Onset of neurological manifestations

Exclusion criteria:

1. Pregnant and nursing women.

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:

N/A

Target sample size:

80

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:

Biochemestry. PhD , Titular Professor

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15. Atabey. Playa

City:

No entered

País:

Havana

Zip Code:

11600

Telephone:

+537-2142146

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:

Tania

Last Name:

Crombet Ramos

Specialty:

I and II Degree in Immunology. Titular professor

Affiliation:

Center of Molecular immunology

Postal Address:

216 and 15. Atabey. Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+5372143143

Email :

taniac@cim.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Instituto Medicina Tropical Pedro Kouri

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

27/03/2020

Postal address of Ethic Committee :

Autopista Novia del Mediodia 6 1/2 entre Autopista Nacional y Carretera Central CP. 11 400

Telephone:

+5372020430 al 44

Correo electrónico:

daniel@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

60

Study completion date:

31/07/2020

Date of available results:

30/11/2020

Date of first publication:

13/05/2020

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:

RPCEC00000311

Date of Registration in Primary Registry:

12/05/2020

Record Verification Date:

2020/05/12

Next update date:

2021/05/12

Link to the spanish version:

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Treatment of SARS CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab

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