NCT04332094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Apr 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

March 31, 2020

Last Update Submit

May 3, 2021

Conditions

COVID-19

Keywords

Tocilizumab

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.

Drug: TocilizumabDrug: HydroxychloroquineDrug: Azithromycin

Control

ACTIVE COMPARATOR

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

Drug: HydroxychloroquineDrug: Azithromycin

Interventions

TocilizumabDRUG

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

Intervention
HydroxychloroquineDRUG

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

ControlIntervention
AzithromycinDRUG

500 mg / day v.o. for 3 days

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Valencia, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, Valencia, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Sant Joan Despí

Barcelona, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumabHydroxychloroquineAzithromycin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Pere Domingo, MD, PhD

CONTACT

pdomingo@santpau.cat

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

April 2, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

ES(7)