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

Not Applicable

Recruiting

• Conditions: Betacoronavirus; SARS-CoV-2; SARS Virus; Severe Acute Respiratory Syndrome; Coronaviridae Infections; severe SARS-CoV-2 pneumonia; COVID-19; Coronavirus Infections

• Registration Number: RPCEC00000311
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-12
• Results First Posted: 2020-05-13
• Study Completion: 2020-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br><br>