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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332094
Recruitment Status : Unknown
Verified May 2021 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : April 2, 2020
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: Through hospitalization, an average of 2 weeks ]
  2. Need for mechanical ventilation in the Intensive Care Unit [ Time Frame: Through hospitalization, an average of 2 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332094


Contacts
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Contact: Pere Domingo, MD, PhD pdomingo@santpau.cat

Locations
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Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain
Contact: Victor Asensi         
Hospital General Universitario de Alicante Recruiting
Alicante, Valencia, Spain
Contact: Esperanza Merino         
Hospital General Universitario de Elche Recruiting
Elche, Valencia, Spain
Contact: Felix Gutierrez         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Pere Domingo, MD, PhD       pdomingo@santpau.cat   
Principal Investigator: Pere Domingo, MD, PhD         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Juan Pablo Horcajada         
Hospital Sant Joan Despí Recruiting
Barcelona, Spain
Contact: Ana Coloma         
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Contact: Vicente Estrada         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Instituto de Salud Carlos III
More Information
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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: April 2, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Tocilizumab
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Coronaviridae Infections
Hydroxychloroquine
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents