Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

Sponsor
Azienda USL Reggio Emilia - IRCCS
Study ID
NCT04346355
Phase
PHASE2
Status
Terminated

Conditions

  • COVID-19 Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — 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

Study Details

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.

Key Dates

Start date
Mar 31, 2020
Status verified
Jun 2020
Primary completion
Jun 6, 2020
Completion
Jun 6, 2020

Study Design

Enrollment
126 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Other: 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

Primary Outcome Measure

Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation [ Time Frame: two weeks from participants' allocation to study arm ]

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