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

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000311
• Date of registration: 12/05/2020
• Prospective Registration: No
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Treatment of SARS CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab
• Scientific title: Treatment of patients with severe SARS-CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab. (COVID-19) - VICTORIA
• Date of first enrolment: 28/03/2020
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000311-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: N/A

Countries of recruitment

Cuba

Contacts

• Name: Mayra Ramos-Suzarte
• Affiliation: Center of Molecular Immunology

• Name: Tania Crombet Ramos
• Affiliation: Center of Molecular immunology

Key inclusion & exclusion criteria

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.

Age minimum: 18 years old
Age maximum: none
Gender: Male/Female

Health Condition(s) or Problem(s) studied

SARS-CoV-2

SARS Virus

Betacoronavirus

Coronavirus Infections

COVID-19

Coronaviridae Infections

Severe Acute Respiratory Syndrome

severe SARS-CoV-2 pneumonia
COVID-19


SARS-CoV-2

Intervention(s)

Antibodies, Monoclonal, Humanized

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

Antibodies, Monoclonal

Infusions, Intravenous

Itolizumab

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.

Secondary Outcome(s)

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.

Secondary ID(s)

IIC RD-EC 179

Source(s) of Monetary Support

Center of Molecular Immunology and Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable

Ethics review

Status: Approved
Approval date: 27/03/2020
Contact:

[e-mail]

Instituto Medicina Tropical Pedro Kouri

[phone] al 44

[e-mail]

Results

• Results available: Yes
• Date Posted: 30/11/2020
• Date Completed: 30/11/2020