Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.

Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.

Inclusion Criteria:

• Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
• Understand and agree to abide by the study procedures.
• Adult #18 years of age at the time of inclusion in the study.
• Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
• Severity 3-4 according to the WHO 7-point ordinal scale.

Exclusion Criteria:

• ALT / AST> 5 times the normal limit
• Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
• Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
• Advanced dementia.
• Pregnancy or breastfeeding.
• Anticipation of transfer to another center in the 12 hours at the beginning of the study.
• Allergy to study medication.
• Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
• Streptococcus pneumoniae antigenuria positive before study start.
• Neutropenia <500 / mm3.
• Thrombocytopenia <100,000 / mm3.
• History of diverticulosis.
• Ongoing skin infection (eg, pyodermitis).
• Transplanted patient under immunosuppressive treatment.
• Previous evidence of latent untreated tuberculosis.