Clinical trial NCT04332094: Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Official title: Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: Tocilizumab
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2020-04-02
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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-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.

Primary outcomes:
measure: In-hospital mortality
timeFrame: Through hospitalization, an average of 2 weeks
measure: Need for mechanical ventilation in the Intensive Care Unit
timeFrame: Through hospitalization, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Valencia
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Valencia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sant Joan Despí
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References: