Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
NCT ID: NCT04332094
Last Updated: 2021-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
276 participants
INTERVENTIONAL
2020-04-02
2021-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Hydroxychloroquine
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
Azithromycin
500 mg / day v.o. for 3 days
Tocilizumab
162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
Control
Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
Hydroxychloroquine
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
Azithromycin
500 mg / day v.o. for 3 days
Interventions
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Hydroxychloroquine
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
Azithromycin
500 mg / day v.o. for 3 days
Tocilizumab
162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 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 del Mar
Barcelona, , Spain
Hospital Sant Joan Despí
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Victor Asensi
Role: primary
Esperanza Merino
Role: primary
Felix Gutierrez
Role: primary
Juan Pablo Horcajada
Role: primary
Ana Coloma
Role: primary
Vicente Estrada
Role: primary
Other Identifiers
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IIBSP-COV-2020-23
Identifier Type: -
Identifier Source: org_study_id
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