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

UNKNOWNPHASE2

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)

NCT04332094•Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+5 more criteria

Locations (7)

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

Key Dates

Start Date

April 2, 2020

Primary Completion Date

June 1, 2021

Completion Date

July 1, 2021

Last Updated

May 6, 2021

Enrollment

276

ESTIMATED participants

Conditions

COVID-19

Interventions

Tocilizumab

DRUG

Hydroxychloroquine

DRUG

Azithromycin

DRUG

Contacts

Pere Domingo, MD, PhD

CONTACT

pdomingo@santpau.cat

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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