Tocilizumab Treatment in Patients With COVID-19

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
• Collaborator: Roche Pharma AG

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.