A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

Conditions

• COVID-19 Pneumonia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
• Tocilizumab — DRUG
  Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.

Study Details

This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.

Key Dates

Start date

May 14, 2020

Status verified

Feb 2023

Primary completion

Aug 18, 2020

Completion

Sep 22, 2020

Study Design

Enrollment

377 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
• Experimental: Tocilizumab
  Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.

Primary Outcome Measure

Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 [ Time Frame: Up to Day 28 ]

Locations (32)

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