Status:
UNKNOWN
Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04332094
Start Date
April 2 2020
End Date
July 1 2021
Last Update
May 6 2021
Active Locations (7)
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1
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
2
Hospital General Universitario de Alicante
Alicante, Valencia, Spain
3
Hospital General Universitario de Elche
Elche, Valencia, Spain
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain