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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Tocilizumab
* Drug: Hydroxychloroquine
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Early administration of tocilizumab associated with hydroxychloroquine and azithromycin. | Drug: Tocilizumab<br>* 162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)<br>Drug: Hydroxychloroquine<br>* 400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)<br>Drug: Azithromycin<br>* 500 mg / day v.o. for 3 days<br>|
| Active Comparator: Control<br>Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin. | Drug: Hydroxychloroquine<br>* 400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)<br>Drug: Azithromycin<br>* 500 mg / day v.o. for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | Through hospitalization, an average of 2 weeks | 
| Need for mechanical ventilation in the Intensive Care Unit |  | Through hospitalization, an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tocilizumab