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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04332094

Acronym

TOCOVID

Enrollment

276

Registered

2020-04-02

Start date

2020-04-02

Completion date

2021-07-31

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Tocilizumab

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.

Interventions

DRUGTocilizumab

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

DRUGHydroxychloroquine

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

DRUGAzithromycin

500 mg / day v.o. for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

Spain

Contacts

Primary ContactPere Domingo, MD, PhD

pdomingo@santpau.cat

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026