Itolizumab-Plasmapheresis in patients with COVID-19

Not Applicable

• Conditions: COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Nidovirales Infections; Betacoronavirus

• Registration Number: RPCEC00000380
• Lead Sponsor: Center of Molecular Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study Completion: 2022-10-31
• Results First Posted: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Express voluntariness of the patient, family member or impartial witness.
2. Any gender and skin color
3. Patients 18 years of age and older
4. SARS-CoV-2 infection diagnosed by RT-PCR categorized as moderate high risk or severe and critical patients, presenting any of the following characteristics:
- Confirmed multifocal interstitial pneumonia or,
- Need for oxygen therapy to maintain SO2> 93% or;
- Worsening of lung involvement, defined as one of the following criteria:
- Worsening of oxygen saturation> 3 percentage points or decrease in PaO2> 10%, with stable FiO2 in the last 24h.
-Need to increase FiO2 in order to maintain a stable SO2 or new need for mechanical installation in the last 24 hours.
- Increase in the number and / or extent of lung areas of consolidation.
For confirmed cases RT-PCR positive SYMPTOMATIC RT-PCR positive Moderate high risk.
Patients with manifestations of infection
1-lower respiratory tract WITHOUT signs of severity (mild pneumonia) that are:
2-Patients 65 years of age or older; or
3- Patients who have any of the risk factors associated with mortality in COVID-19 (obesity, complicated HT, ischemic heart disease, diabetes mellitus, COPD, cancer, kidney failure, severe malnutrition, neutrophil / lymphocyte ratio> 4 and others that consider the attending physicians).
Important:
These cases will be treated in a different room with the supervision of the intensivists. Each case will be evaluated individually (if the disease has been evolving for 8 days or more, treatment with Heberferon should be suspended, and prophylactic anticoagulant treatment should be indicated in cases that meet the criteria for said therapy).
5. Alternatively, Itolizumab can be used in patients with suspected 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 choppy speech (cannot quickly count to 20 after a deep breath)
• Respiratory rate greater than 22 breaths per minute with oxygen therapy at 6L / min
• PO2: Partial pressure of arterial oxygen <65 mm Hg
• Worsening of the radiological image
• Fever =38ºC
• Reduction in baseline hemoglobin, platelets or neutrophils oHb <90 g / L, platelets <100 x109 / L, neutrophils <1 x109 / L or leukocytes <4 x109 / L.
• Decrease in erythrocyte sedimentation in disagreement with C-reactive protein (pcr) (low erythrocyte sedimentation and CRP increases or does not change)
• Increase in the initial value of triglycerides or triglycerides greater than 3 mmol. / L.
• Increase in the initial value of ferritin from 500 ng / ml or absolute value of ferritin = 2000 ng / ml.
• Aspartate aminotransferase transaminase =30 IU / L
• Increase in D-dimer
• Fibrinogen <2.5 g / L
• Appearance of neurological manifestations.
In addition, they must meet the specific criteria for the execution of the plasmapheresis procedure;
6. Weight of the patient more than 57 kg and height greater than 1.10 m.
7. Moderate patients at high risk, whose clinical and laboratory manifestations worsen.
8. Neutrophil / lymphocyte ratio> 5, whether or not Itolizumab has been administered
9. Coagulation test: Clotting time (5 to 11 minutes)

Exclusion Criteria

1. Pregnant or lactating women.
2. Patients under 18 years of age.
3. Patients with hypercoagulation
4. Cancer patients
5. Patients with severe malnutrition, uncontrolled heart disease, patients previously subjected to cardiovascular surgery, with peptic ulcers or upper or lower limb amputation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1- Recovery rate (The proportion of patients considered recovered will be calculated in relation to the total number of patients who received the therapeutic combination). Measurement time: At hospital discharge. <br>2- Rate of patients with disease progression (worsening in the classification of clinical status. According to the World Health Organization classification of Moderate, Severe, Critical (Stable, Unstable), any change in status during the evaluation period will be considered Progression). Measurement time: from the first plasmapheresis session at 0, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days or until hospital discharge or death of the patient. <br>