Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

NCT ID: NCT04346355

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2020-06-06

Brief Summary

The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Tocilizumab within 8 hours from entering the study + standard of care; 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours

Control Arm

Standard of care; In the event of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours

Group Type: OTHER

Tocilizumab

Intervention Type: DRUG

In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours

Interventions

Tocilizumab

In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours

Intervention Type: DRUG

Other Intervention Names

Standard of care

Eligibility Criteria

Inclusion Criteria

• age > 18 years
• Informed consent for participation in the study
• Real time polymerase chain reaction (PCR) diagnosis of Sars-CoV2 infection
• Hospitalization due to clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or pulmonary ultrasound)
• Presence of acute respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) between 200 and 300 mm/Hg
• Presence of exaggerated inflammatory response defined by the presence of at least 1 of the following criteria:
• At least one body temperature measurement >38° C in the past two days;
• Serum CRP greater than or equal to 10 mg/dl;
• CRP increase of at least twice the basal value

Exclusion Criteria

• Patients with respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) <200 mm/Hg or
• Patients in non-invasive ventilation or
• Patients in invasive ventilation or presence of shock or presence of concomitant organ failure that requires admission to the Intensive Care Unit
• Severe heart and kidney failure
• Pregnant or breastfeeding patient
• Patient who, in the opinion of the clinician or by the patient's express will, will not go to intensive care regardless of the evolution of the lung picture.
• Known hypersensitivity to TCZ or its excipients
• Patient being treated with immuno-depressors or anti-rejection drugs
• Known active infections or other clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment
• glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) > 5 times the upper limit of the norm
• Neutrophils <500 /mmc
• Platelets <50.000 /mmc
• Diverticulitis or intestinal perforation
• Suspicion of latent tuberculosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Salvarani, M.D.

Role: STUDY_DIRECTOR

Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

Massimo Costantini, Ph.D.

Role: STUDY_DIRECTOR

Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

Locations

Ospedale di Guastalla

Guastalla, RE, Italy

Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

Reggio Emilia, RE, Italy

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Policlinico Sant'Orsola Malpighi

Bologna, , Italy

ASST Cremona

Cremona, , Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, , Italy

Azienda Ospedaliero Universitaria Ferrara

Ferrara, , Italy

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Ospedale Evangelico Internazionale di Genova

Genova, , Italy

Azienda Sociosanitaria ASL 1 ,Imperia

Imperia, , Italy

Azienda Sociosanitaria ASL 5 La Spezia

La Spezia, , Italy

ASST Mantova - Ospedale Carlo Poma

Mantova, , Italy

IRCCS Istituto Auxologico Italiano Milano

Milan, , Italy

Azienda Ospedaliero-Universitaria "Maggiore della Carità" di Novara

Novara, , Italy

Ospedali Riuniti Padova Sud - ULSS 6 Euganea

Padua, , Italy

Azienda Ospedaliero-Universitaria Parma

Parma, , Italy

Azienda Unità Sanitaria Locale di Piacenza

Piacenza, , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

AO Ordine Mauriziano di Torino

Torino, , Italy

ASST Bergamo Ovest -Treviglio

Treviglio, , Italy

AULSS 2 Marca Trevigiana

Treviso, , Italy

AULSS2 Marca Trevigiana - Ospedale Vittorio Veneto

Treviso, , Italy

AULSS 3 Serenissima Ospedale "Dell'Angelo"

Venezia, , Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , Italy

IRCCS Sacro Cuore Don Calabria

Verona, , Italy

Countries

Italy

References

Salvarani C, Dolci G, Massari M, Merlo DF, Cavuto S, Savoldi L, Bruzzi P, Boni F, Braglia L, Turra C, Ballerini PF, Sciascia R, Zammarchi L, Para O, Scotton PG, Inojosa WO, Ravagnani V, Salerno ND, Sainaghi PP, Brignone A, Codeluppi M, Teopompi E, Milesi M, Bertomoro P, Claudio N, Salio M, Falcone M, Cenderello G, Donghi L, Del Bono V, Colombelli PL, Angheben A, Passaro A, Secondo G, Pascale R, Piazza I, Facciolongo N, Costantini M; RCT-TCZ-COVID-19 Study Group. Effect of Tocilizumab vs Standard Care on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):24-31. doi: 10.1001/jamainternmed.2020.6615.

Reference Type: DERIVED

PMID: 33080005 (View on PubMed)

Other Identifiers

2020-001386-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RCT-TCZ-COVID-19

Identifier Type: -

Identifier Source: org_study_id