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.
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
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.
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
Pere Domingo, MD, PhD
pdomingo@santpau.cat