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

Phase 2

• Conditions: COVID-19
• Interventions: Drug: Tocilizumab; Drug: Hydroxychloroquine; Drug: Azithromycin

• Registration Number: NCT04332094
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-01
• Study Start: 2020-04-02
• Study First Posted: 2020-04-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Azithromycin	Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Intervention	Tocilizumab	Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Intervention	Hydroxychloroquine	Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Control	Azithromycin	Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
Control	Hydroxychloroquine	Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.

Primary Outcome Measures

Name	Time	Method
Need for mechanical ventilation in the Intensive Care Unit	Through hospitalization, an average of 2 weeks
In-hospital mortality	Through hospitalization, an average of 2 weeks

Trial Locations

Locations (7)

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Valencia, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Valencia, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Sant Joan Despí; 🇪🇸 Barcelona, Spain