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

Unknown status
COVID-19

Drug: Tocilizumab

162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)

Drug: Hydroxychloroquine

400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)

Drug: Azithromycin

500 mg / day v.o. for 3 days

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital Universitario Central de Asturias
Oviedo, 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

Contacts

Pere Domingo, MD, PhD
pdomingo@santpau.cat

Instituto de Salud Carlos III
NCT Number
Keywords
Tocilizumab
MeSH Terms
COVID-19
Azithromycin
Hydroxychloroquine