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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborator: Instituto de Salud Carlos III
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

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.