Itolizumab Safety and Efficacy Study in Covid 19

Not Applicable

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

• Registration Number: RPCEC00000361
• Lead Sponsor: Center of Molecular Immunology(CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-26
• Study Completion: 2021-07-30
• Results First Posted: 2021-08-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Express voluntariness of the patient, family member or impartial witness.
2. Any gender and skin color
3. Age equal to or greater than 18 years
4. SARS-CoV-2 infection diagnosed by RT-PCR that presents any of the following characteristics:
4.1 Confirmed multifocal interstitial pneumonia or,
4.2 Need for oxygen therapy to maintain SO2> 93% or;
4.3 Worsening of lung involvement, defined as one of the following criteria:
4.3.1 Worsening of oxygen saturation> 3 percentage points or decrease in PaO2> 10%, with stable FiO2 in the last 24h.
4.3.2 Need to increase FiO2 in order to maintain a stable SO2 or new need for mechanical installation in the last 24 hours.
4.3.3 Increase in the number and / or extent of lung areas of consolidation.
FOR CONFIRMED CASES RT-PCR positive ASYMPTOMATIC high risk ”which would be:
1. Patients 65 years of age or older or;
2. or 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, and others considered by attending physicians).
This group will be kept under strict clinical surveillance
FOR CONFIRMED CASES RT-PCR positive SYMPTOMATIC RT-PCR positive Moderate high risk”.
1. Patients who present manifestations of lower respiratory infection WITHOUT signs of severity (mild pneumonia) that are:
1.1 Patients 65 years of age or older; or
1.2 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 discontinued, and prophylactic anticoagulant treatment should be indicated in cases that meet the criteria for such therapy).
Alternatively, itolizumab can be used in patients with suspected macrophage activation syndrome, according to the following criteria:
1. Need for oxygen therapy not less than 6L / min plus one of the following conditions:
1.1 Wheezing or choppy speech (cannot quickly count to 20 after a deep breath)
1.2 Respiratory rate greater than 22 breaths per minute with oxygen therapy at 6L / min
1.3 PO2: Partial pressure of arterial oxygen <65 mm Hg
1.4 Worsening of the radiological image
1.5 Fever =38ºC
1.6 Reduction in baseline values ??of hemoglobin, platelets or neutrophils or Hb <90 g / L, platelets <100 x109 / L, neutrophils <1 x109 / L or leukocytes <4 x109 / L.
1.7 Decrease in erythrocyte sedimentation in disagreement with C-reactive protein (pcr) (low erythrocyte sedimentation and CRP increases or is not modified)
1.8 Increase in the initial value of triglycerides or triglycerides greater than 3 mmol. / L.
1.9 Increase in the initial value of ferritin from 500 ng / ml or absolute value of ferritin = 2000 ng / ml.
1.10 Aspartate aminotransferase transaminase =30 IU / L
1.11 Increase in D-dimer
1.12 Fibrinogen <2.5 g / L
1.13 Appearance of neurological manifestations

Exclusion Criteria

1- Pregnant or nursing women.
2- Under 18 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Security outcomes:<br>1- Serious adverse events: From the total number of patients who will receive treatment, the percentage that developed serious adverse events will be calculated, according to the CTCAE v5.0 classification. Measurement time: Upon discharge of the patient.<br>2- Clinical and laboratory adverse events: The frequency distribution of AD appearance, type of event and body system will be determined. Duration, intensity, result, attitude and causal relationship of the AE will be identified. Measurement time: Upon discharge of the patient.<br>Effect outcomes:<br>3- Rate of deceased patients in 14 days following the use of the drug. Measurement time: Upon discharge of the patient.<br>4- Rate of patients with disease progression (worsening in clinical status classification). Measurement time: Upon discharge of the patient.

Secondary Outcome Measures

Name	Time	Method
1- Proportion of Patients at Risk of Progression According to the CALL Index. Measurement time: Upon discharge of the patient.<br>2- Proportion of patients with high risk according to the MINSAP classification. Measurement time: Upon discharge of the patient.<br>3- Length of stay in intensive care. Measurement time: Upon discharge of the patient.<br>4- Hospital stay time. Measurement time: Upon discharge of the patient.