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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Recruiting

CT.gov ID

NCT04332094

Collaborator

Instituto de Salud Carlos III (Other)

276

Enrollment

Locations

Arms

14.9

Anticipated Duration (Months)

39.4

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Tocilizumab Drug: Hydroxychloroquine Drug: Azithromycin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

276 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 2, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.	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
Active Comparator: Control Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.	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

Arm

Intervention/Treatment

Experimental: Intervention

Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.

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

Active Comparator: Control

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain
2	Hospital General Universitario de Alicante	Alicante	Valencia	Spain
3	Hospital General Universitario de Elche	Elche	Valencia	Spain
4	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
5	Hospital del Mar	Barcelona		Spain
6	Hospital Sant Joan Despí	Barcelona		Spain
7	Hospital Clinico San Carlos	Madrid		Spain

Sponsors and Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Instituto de Salud Carlos III

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT04332094

Other Study ID Numbers:

IIBSP-COV-2020-23

First Posted:

Apr 2, 2020

Last Update Posted:

May 6, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tocilizumab

Additional relevant MeSH terms:

COVID-19

Azithromycin

Hydroxychloroquine

Study Results

No Results Posted as of May 6, 2021