Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Overview
- Phase
- Phase 2
- Intervention
- Tocilizumab
- Conditions
- COVID-19
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 276
- Locations
- 7
- Primary Endpoint
- Need for mechanical ventilation in the Intensive Care Unit
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility 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-
- •Streptococcus pneumoniae antigenuria positive before study start.
- •Neutropenia \<500 / mm
Arms & Interventions
Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Intervention: Tocilizumab
Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Intervention: Hydroxychloroquine
Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Intervention: Azithromycin
Control
Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
Intervention: Hydroxychloroquine
Control
Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
Intervention: Azithromycin
Outcomes
Primary Outcomes
Need for mechanical ventilation in the Intensive Care Unit
Time Frame: Through hospitalization, an average of 2 weeks
In-hospital mortality
Time Frame: Through hospitalization, an average of 2 weeks