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

NCT04372186 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ML42528
• Study Type: interventional
• Target: 377
• Locations: 6 countries
• Sites: 44

Brief Summary

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

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

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

  Up to Day 28

Secondary Outcomes (6)

• 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)

  Up to Day 28

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

  Up to Day 28

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

  Up to Day 28

• Mortality Rate by Day 28

  Up to Day 28

• Clinical Status on 7-Category Ordinal Scale at Day 28

  Day 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.

Drug: Placebo

Tocilizumab

EXPERIMENTAL

Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.

Drug: Tocilizumab

Interventions

Placebo DRUG

Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.

Placebo

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.

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized
• COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
• SpO2 \< 94% while on ambient air
• Participated in Study ML42528 (EMPACTA) (includes participants who completed or discontinued early from the main study)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (44)

Banner - University Medical Center Phoenix; In-Patient Pharmacy

Phoenix, Arizona, 85006, United States

Location

Univ of AZ Coll of Med

Tucson, Arizona, 85724, United States

Location

El Centro Regional Medical Center

El Centro, California, 92243, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Highland Hospital Oakland

Oakland, California, 94602, United States

Location

St. Joseph'S Hospital

Orange, California, 92563, United States

Location

San Leandro Hospital; Inpatient Pharmacy

San Leandro, California, 94578, United States

Location

Larkin Community Hospital Palm Springs Campus (Hialeah)

Hialeah, Florida, 33012, United States

Location

Miami Veterans Administration Healthcare System - NAVREF

Miami, Florida, 33125, United States

Location

University of Miami Pulmonary

Miami, Florida, 33125, United States

Location

Larkin Community Hospital

South Miami, Florida, 33143, United States

Location

St. Lukes Boise Medical Center

Boise, Idaho, 83712, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Holy Cross Germantown Hospital

Germantown, Maryland, 20876, United States

Location

Holy Cross Hospital

Silver Spring, Maryland, 20910, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

St. Joseph'S Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

SUNY Downstate Medical Center.

Brooklyn, New York, 11203, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Flushing Hospital

Flushing, New York, 11355, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Harlem Hospital

New York, New York, 10037, United States

Location

Canton-Potsdam Hospital

Potsdam, New York, 13676, United States

Location

St. Barnabas Hospital

The Bronx, New York, 10457, United States

Location

Novant Health Presbyterian Medical Center (Presbyterian Hospital)

Charlotte, North Carolina, 28204, United States

Location

Cape Fear Valley Medical Center

Fayetteville, North Carolina, 28304, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

Michael E Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

McAllen Medical Center

McAllen, Texas, 78503, United States

Location

Sentara Medical Group

Virginia Beach, Virginia, 23462, United States

Location

Hospital E Maternidade Celso Pierro PUCCAMP

Campinas, São Paulo, 13060-904, Brazil

Location

Centro Multidisciplinar de Estudos Clínicos CEMEC FMABC

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

BR Trials - Pesquisa Clínica

São Paulo, São Paulo, 03325-050, Brazil

Location

Aga Khan University Hospital

Nairobi, 30270-00100, Kenya

Location

Hospital General de Culiacan

Culiacán, 80230, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, Mexico

Location

Hospital Militar Central

Jesus Maria, Lima 11, Peru

Location

Hospital Nacional Sergio E. Bernales

Lima, 15003, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, 31, Peru

Location

Hospital Nacional Hipolito; Unanue

Lima, Lima 10, Peru

Location

Hospital Maria Auxiliadora

Lima, Lima 29, Peru

Location

George Provincial Hospital

George, 6259, South Africa

Location

Related Publications (2)

• Salama C, Han J, Yau L, Reiss WG, Kramer B, Neidhart JD, Criner GJ, Kaplan-Lewis E, Baden R, Pandit L, Cameron ML, Garcia-Diaz J, Chavez V, Mekebeb-Reuter M, Lima de Menezes F, Shah R, Gonzalez-Lara MF, Assman B, Freedman J, Mohan SV. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jan 7;384(1):20-30. doi: 10.1056/NEJMoa2030340. Epub 2020 Dec 17.

  PMID: 33332779 DERIVED

• Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.

  PMID: 33201228 DERIVED

MeSH Terms

Interventions

tocilizumab

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genetech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: May 14, 2020
• Primary Completion: August 18, 2020
• Study Completion: September 22, 2020
• Last Updated: February 10, 2023
• Results First Posted: September 27, 2021

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

PE (5); ME (2); ZA (1); KE (1); BR (3); US (32)