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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Tocilizumab
Hydroxychloroquine
Azithromycin
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Tocilizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital General Universitario de AlicanteRecruiting
  • Hospital General Universitario de ElcheRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital del MarRecruiting
  • Hospital Sant Joan DespíRecruiting
  • Hospital Clinico San CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.

Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.

Outcomes

Primary Outcome Measures

In-hospital mortality
Need for mechanical ventilation in the Intensive Care Unit

Secondary Outcome Measures

Full Information

First Posted
March 31, 2020
Last Updated
May 3, 2021
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT04332094
Brief Title
Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Acronym
TOCOVID
Official Title
Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Tocilizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
500 mg / day v.o. for 3 days
Primary Outcome Measure Information:
Title
In-hospital mortality
Time Frame
Through hospitalization, an average of 2 weeks
Title
Need for mechanical ventilation in the Intensive Care Unit
Time Frame
Through hospitalization, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Domingo, MD, PhD
Email
pdomingo@santpau.cat
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Asensi
Facility Name
Hospital General Universitario de Alicante
City
Alicante
State/Province
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esperanza Merino
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Gutierrez
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Domingo, MD, PhD
Email
pdomingo@santpau.cat
First Name & Middle Initial & Last Name & Degree
Pere Domingo, MD, PhD
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Pablo Horcajada
Facility Name
Hospital Sant Joan Despí
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Coloma
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Estrada

12. IPD Sharing Statement

Learn more about this trial

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

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