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

COVID-19 Clinical Trial

— TOCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332094
• Other study ID #: IIBSP-COV-2020-23
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2020
• Est. completion date: July 2021

Study information

• Verified date: May 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Pere Domingo, MD, PhD
• Email: pdomingo[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Drug:
• Tocilizumab
162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
• Hydroxychloroquine
400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
• Azithromycin
500 mg / day v.o. for 3 days

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante	Valencia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Joan Despí	Barcelona
Spain	Hospital General Universitario de Elche	Elche	Valencia
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		Through hospitalization, an average of 2 weeks
Primary	Need for mechanical ventilation in the Intensive Care Unit		Through hospitalization, an average of 2 weeks