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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Unknown; Phase 2

Conditions: COVID-19

Treatments: Drug: Azithromycin; Drug: Tocilizumab; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04332094

IIBSP-COV-2020-23

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Intervention

Experimental group

Description:

Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.

Treatment:

Drug: Hydroxychloroquine

Drug: Tocilizumab

Drug: Azithromycin

Control

Active Comparator group

Description:

Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.

Treatment:

Drug: Hydroxychloroquine

Drug: Azithromycin