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Completed

NCT Number: NCT04372186

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

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.

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Key information

Conditions

COVID-19 Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital E Maternidade Celso Pierro PUCCAMP, Campinas, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized
  • COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
  • SpO2 < 94% while on ambient air

Inclusion criteria

Specific to Long-Term Extension

  • Participated in Study ML42528 (EMPACTA) (includes participants who completed or discontinued early from the main study)

Exclusion criteria

  • Known severe allergic reactions to TCZ or other monoclonal antibodies
  • Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
  • Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
  • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
  • Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
  • Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
  • Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory reference ranges)
  • Platelet count < 50,000/uL at screening (according to local laboratory reference ranges)
  • Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
  • Treatment with an investigational drug within 5 half lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medical Monitor)
  • Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
  • Any history of Diverticulitis or GI perforation
  • Use of systemic corticosteroids unless on a stable chronic dose

Treatment and study plan

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.

Primary outcomes

  1. Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28

    Time frame: Up to Day 28

    Cumulative proportion is measured as a percentage of participants meeting the endpoint.

Secondary outcomes

  1. Time to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or >/= 2 Liters (L) Supplemental Oxygen)

    Time frame: Up to Day 28

  2. Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status

    Time frame: Up to Day 28

    Clinical status was assessed using a 7-category ordinal scale:

    • - Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </=2 liters supplemental oxygen)
    • - Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
    • - Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
    • - ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
    • - ICU, requiring intubation and mechanical ventilation
    • - ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support
    • - Death

  3. Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)

    Time frame: Up to Day 28

  4. Mortality Rate by Day 28

    Time frame: Up to Day 28

  5. Clinical Status on 7-Category Ordinal Scale at Day 28

    Time frame: Day 28

    Clinical status was assessed using a 7-category ordinal scale:

    • - Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </=2 liters supplemental oxygen)
    • - Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
    • - Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
    • - ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
    • - ICU, requiring intubation and mechanical ventilation
    • - ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support
    • - Death

  6. Percentage of Participants With Adverse Events

    Time frame: Up to Day 60

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia

Acronym: EMPACTA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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