Tocilizumab Treatment in Patients With COVID-19

NCT04363853 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: INF-3343-20-22-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II clinical trial will be carried out with the objective of studying the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the high mortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will not be included. Patients will be recruited by signing an informed consent and the baseline variables of interest will be recorded. Tocilizumab will be administered in one or two doses, depending on the case, and will be followed up for 30 days. The response to treatment, survival and evolution will be studied. Factors associated with improvement of ARDS and survival will be identified through multivariate analyzes. The results will be compared with those reported internationally.

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (18)

• Hematic biometry

  Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  24 hours

• Blood chemistry

  Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  24 hours

• Blood gas

  Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  24 hours

• Hematic biometry

  Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  48 hours

• Blood chemistry

  Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  48 hours

• blood gas

  Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  48 hours

• Hematic biometry

  Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  72 hours

• Blood chemistry

  Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  72 hours

• blood gas

  Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  72 hours

• Hematic biometry

  Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  7 days

• Blood chemistry

  Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  7 days

• blood gas

  Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  7 days

• Hematic biometry

  Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  14 days

• Blood chemistry

  Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  14 days

• blood gas

  Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  14 days

• thorax radiography

  Until removal of mechanical ventilation. Monitoring for signs of pneumonia imaging.

  24 hours

• thorax radiography

  Until removal of mechanical ventilation. Monitoring for signs of pneumonia imaging.

  7 days

• thorax radiography

  Until removal of mechanical ventilation. Monitoring for signs of pneumonia imaging.

  14 days

Study Arms (1)

Tocilizumab tratment

EXPERIMENTAL

Tocilizumab (RoActembra). Vials of 20 ml with 400 mg (20mg/ml) and 4ml with 80 mg (20mg/ml). A singe 60-minute IV infusion of 8mg/kg (maximum dose of 800 mg). Dose was not adjusted for weight more than 100 kg. After first dose, if fiver persists within 12 hours, a second dose was administrated. A maximum of two doses was allowed.

Drug: Tocilizumab 20 MG/ML

Interventions

Tocilizumab 20 MG/ML DRUG

We study the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection.

Tocilizumab tratment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• Diagnosis of SARS-CoV-2 infection by RT-PCR
• Diagnosis of serious or critical illness, without mechanical ventilation or with less than 24 hours of mechanical ventilation.
• Severe: dyspnea, increase in respiratory rate ≥ 30 breaths / min, oxygen saturation \<90% or PaO2 \<60 mmHg or increase in supplemental oxygen requirement more than 3% from baseline, PaO2 / FiO2 \<300 mmHg, and / or pulmonary infiltrates by image\> 50% within 24 to 48 hours of symptom onset.
• Critical: respiratory failure (alteration in gas exchange with PaO2 \<60 mmHg with or without elevation of PaCO2\> 33 mmHg), septic shock (hypotension secondary to sepsis with a requirement for vasopressors to maintain a mean arterial pressure\> 65 mmHg and lactate\> 2 mmol / l).
• Signature of informed consent by the patient, family member or legal representative
• Negative pregnancy test for women of childbearing age.
• Male patients who agree to use barrier methods when having sexual intercourse in the following 80 days after receiving tocilizumab
• Patients receiving immunomodulatory treatment (cancer, transplant recipients or other diseases) that may temporarily suspend the drug.

You may not qualify if:

• Pregnant or lactating women.
• Patients who by indication of their treating doctor cannot suspend previous immunomodulatory treatment.
• Known allergic reactions to Tocilizumab or any excipients.
• Patients receiving systemic steroids at a dose greater than 1 mg / Kg of weight per day in prednisone equivalents
• Patients with SOFA score\> 15 points that predicts 90% mortality on admission
• The decision of the attending physician not to include the patient due to the presence of any condition that does not allow the administration of the drug to be safe.
• Diverticulitis or intestinal perforation
• Patients with any of the following active infections: viral hepatitis, tuberculosis, HIV infection, bacterial and/or fungal and/or viral infections (other than SARS-CoV-2 infection) suspected or diagnosed using compatible microbiological isolation.
• Alanine aminotransferase/aspartate aminotransferase values\> 5 times the upper limit of normal
• Neutrophil values \<1000/ml,
• Platelet values \<50,000/ml.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead
• Roche Pharma AG: collaborator

Study Sites (1)

National Cancer Institute of Mexico

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (13)

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  PMID: 31953166 BACKGROUND

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• Hu X, Deng Y, Wang J, Li H, Li M, Lu Z. Short term outcome and risk factors for mortality in adults with critical severe acute respiratory syndrome (SARS). J Huazhong Univ Sci Technolog Med Sci. 2004;24(5):514-7. doi: 10.1007/BF02831124.

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• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

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  PMID: 31950516 BACKGROUND

• Schmitt J, Boutonnet M, Goutorbe P, Raynaud L, Carfantan C, Luft A, Pasquier P, Meaudre E, Bordes J. Acute respiratory distress syndrome in the forward environment. Retrospective analysis of acute respiratory distress syndrome cases among French Army war casualties. J Trauma Acute Care Surg. 2020 Aug;89(2S Suppl 2):S207-S212. doi: 10.1097/TA.0000000000002633.

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• Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.

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MeSH Terms

Interventions

tocilizumab

Study Officials

• Óscar Arrieta, M.D.,M.Sc.

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc Head of Thoracic Oncology Unit

Model Details: Phase II, single-arm, open-label, prospective, blinded, clinical trial with Tocilizumab as the sole agent.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 27, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available in July 2020

Locations

ME (1)