COVID-19 PneumoniaPhase 3EMPACTANCT04372186
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
A Phase 3 study testing Tocilizumab in people with COVID-19 Pneumonia, run by Genentech, Inc. at 44 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 377 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 14 May 2020to 22 Sep 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
United States32 sites
St. Lukes Boise Medical Center
Boise, Idaho, 83712
SUNY Downstate Medical Center.
Brooklyn, New York, 11203
Novant Health Presbyterian Medical Center (Presbyterian Hospital)
Charlotte, North Carolina, 28204
Henry Ford Health System
Detroit, Michigan, 48202
El Centro Regional Medical Center
El Centro, California, 92243
Elmhurst Hospital Center
Elmhurst, New York, 11373
San Juan Oncology Associates
Farmington, New Mexico, 87401
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304
Flushing Hospital
Flushing, New York, 11355
Holy Cross Germantown Hospital
Germantown, Maryland, 20876
Valley Baptist Medical Center
Harlingen, Texas, 78550
Larkin Community Hospital Palm Springs Campus (Hialeah)
Hialeah, Florida, 33012
Michael E Debakey VA Medical Center
Houston, Texas, 77030
Jamaica Hospital Medical Center
Jamaica, New York, 11418
eStudySite
La Mesa, California, 91942
McAllen Medical Center
McAllen, Texas, 78503
Miami Veterans Administration Healthcare System - NAVREF
Miami, Florida, 33125
University of Miami Pulmonary
Miami, Florida, 33125
Ochsner Clinic
New Orleans, Louisiana, 70121
Harlem Hospital
New York, New York, 10037
Highland Hospital Oakland
Oakland, California, 94602
St. Joseph'S Hospital
Orange, California, 92563
St. Joseph'S Regional Medical Center
Paterson, New Jersey, 07503
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Banner - University Medical Center Phoenix; In-Patient Pharmacy
Phoenix, Arizona, 85006
Canton-Potsdam Hospital
Potsdam, New York, 13676
San Leandro Hospital; Inpatient Pharmacy
San Leandro, California, 94578
Holy Cross Hospital
Silver Spring, Maryland, 20910
Larkin Community Hospital
South Miami, Florida, 33143
St. Barnabas Hospital
The Bronx, New York, 10457
Univ of AZ Coll of Med
Tucson, Arizona, 85724
Sentara Medical Group
Virginia Beach, Virginia, 23462
Peru5 sites
Hospital Militar Central
Jesus Maria, Lima 11
Hospital Nacional Sergio E. Bernales
Lima, 15003
Hospital Nacional Cayetano Heredia
Lima, 31
Hospital Nacional Hipolito; Unanue
Lima, Lima 10
Hospital Maria Auxiliadora
Lima, Lima 29
Brazil3 sites
Hospital E Maternidade Celso Pierro PUCCAMP
Campinas, São Paulo, 13060-904
Centro Multidisciplinar de Estudos Clínicos CEMEC FMABC
São Bernardo do Campo, São Paulo, 09715-090
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, 03325-050
Mexico2 sites
Hospital General de Culiacan
Culiacán, 80230
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Placebo, Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
TocilizumabDrug
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given. Receives: Drug: Placebo |
| Tocilizumab | Experimental | Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Up to Day 28
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
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
Measured: Up to Day 28
Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First)
Measured: Up to Day 28
Mortality Rate by Day 28
Measured: Up to Day 28
Clinical Status on 7-Category Ordinal Scale at 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
Measured: Day 28
Percentage of Participants With Adverse Events
Measured: Up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start14 May 2020
- Primary completion18 Aug 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372186
- Sponsor's protocol ID
- ML42528
- Acronym
- EMPACTA
- Status last verified
- Feb 2023
- First submitted
- 29 Apr 2020
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
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.
PubMed 33332779Tleyjeh 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.
PubMed 33201228
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04372186
- Acronym / sponsor ID
- EMPACTA / ML42528
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 May 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 27 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given. |
| Tocilizumab | Experimental | Drug: TocilizumabParticipants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given. | Drug | Placebo |
| TocilizumabParticipants 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. | Drug | Tocilizumab |
Primary outcome
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.
6 secondary outcomes
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
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
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
Mortality Rate by Day 28
Time frame: Up to Day 28
Clinical Status on 7-Category Ordinal Scale at Day 28
Time frame: Day 28
Percentage of Participants With Adverse Events
Time frame: Up to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33332779Salama 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.
- Derived from this study: PubMed 33201228Tleyjeh 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.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Related trials for COVID-19 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab in people with COVID-19 Pneumonia, run by Genentech, Inc. at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Peru, Brazil, Mexico, Kenya and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372186, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.