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A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380961
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.

Condition or disease Intervention/treatment Phase
Severe or Critical Confirmed Coronavirus Disease (COVID)-19 Drug: Sirukumab Drug: Placebo Other: Standard of Care (SOC) Phase 2

Expanded Access : Janssen Pharmaceutica N.V., Belgium has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : June 25, 2020
Estimated Study Completion Date : September 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sirukumab
Participants will receive single intravenously (IV) dose infusion of sirukumab 5 milligram per kilogram (mg/kg) on Day 1 along with standard of care treatment.
Drug: Sirukumab
Participants will receive sirukumab 5 mg/kg IV single dose infusion on Day 1.
Other Name: CNTO136

Other: Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.

Placebo Comparator: Placebo
Participants will receive IV single dose infusion of placebo on Day 1 along with standard of care treatment.
Drug: Placebo
Participants will receive placebo IV single dose infusion on Day 1.

Other: Standard of Care (SOC)
SOC treatment will be determined by the investigator based on local practice and consists of supportive care.




Primary Outcome Measures :
  1. Time to Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale [ Time Frame: Up to Day 28 ]
    Time to improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale. The 6-point ordinal clinical recovery scale provides 6 mutually exclusive conditions ordered from best to worst, and the score reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are : not hospitalized (category 1); Hospitalization; not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO (category 5); death (category 6).


Secondary Outcome Measures :
  1. Percentage of Participants with an Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28 [ Time Frame: Day 28 ]
    Percentage of participants with an improvement of at Least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.

  2. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 28 ]
    A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.

  3. Percentage of Participants with Related Adverse Events [ Time Frame: Up to Day 28 ]
    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

  4. Percentage of Participants with Severe or Life Threatening Bacterial, Invasive Fungal, Viral or Opportunistic Infections [ Time Frame: Up to Day 28 ]
    Percentage of participants with severe or life-threatening, bacterial, invasive fungal, viral or opportunistic infections (other than severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) will be reported.

  5. Percentage of Participants with Grade 3 and 4 Neutropenia [ Time Frame: Up to Day 28 ]
    Percentage of participants with grade 3 (severe) or 4 (life-threatening) neutropenia will be reported.

  6. Percentage of Participants with Grade 3 and 4 Lymphocytopenia [ Time Frame: Up to Day 28 ]
    Percentage of participants with grade 3 (severe) or 4 (life-threatening) lymphocytopenia will be reported.

  7. Percentage of Participants with Increased Alanine Aminotransferase (ALT) Greater than or equal to 3 Times Upper Limit of Normal (ULN) Combined with Increased Bilirubin > 2 Times ULN [ Time Frame: Up to Day 28 ]
    Percentage of participants with increased ALT >=3 times ULN combined with increased bilirubin >2 times ULN (up to Day 28) will be reported.

  8. Time to Improvement of at least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale [ Time Frame: Up to Day 28 ]
    Time to improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale will be reported.

  9. Percentage of Participants with an Improvement of at Least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28 [ Time Frame: Day 28 ]
    Percentage of participants with an improvement of at Least 1 category relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.

  10. Time from Study Intervention to end of Oxygen Supplementation [ Time Frame: Up to Day 28 ]
    Time from study intervention to end of oxygen supplementation is defined as achieving category 1 or 2 on the 6-point ordinal clinical recovery scale.

  11. Time from Study Intervention to Hospital Discharge Among the Surviving Participants [ Time Frame: Up to Day 28 ]
    Time from study intervention to hospital discharge among the surviving participants will be reported.

  12. Total Length of Hospitalization [ Time Frame: Up to Day 28 ]
    Total length of hospitalization (days from admission to hospital discharge) among the surviving participants will be reported.

  13. Percentage of Participants with All-cause Mortality [ Time Frame: Up to Day 28 ]
    Percentage of participants with all-cause mortality will be reported.

  14. Number of Ventilation Free Days [ Time Frame: Up to Day 28 ]
    Number of Ventilation free Days will be reported.

  15. Participant's Clinical Status at Day 7, 14, 21, 28 as Assessed by 6-Point Ordinal Clinical Recovery Scale [ Time Frame: Day 7, 14, 21, 28 ]
    Participant's clinical status at Day 7, 14, 21, 28 will be assessed by 6-point ordinal clinical recovery scale.

  16. Total Time on Invasive Mechanical Ventilation [ Time Frame: Up to Day 28 ]
    Total time on invasive mechanical ventilation will be reported.

  17. Percentage of Participants with a Worse Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale over Time [ Time Frame: Up to Day 28 ]
    Percentage of participants with a worse category relative to baseline on the 6-point ordinal clinical recovery scale over time will be reported.

  18. Percentage of Participants on Extracorporeal Membrane Oxygenation (ECMO) Over Time [ Time Frame: Up to Day 28 ]
    Percentage participants on ECMO over time will be reported.

  19. Total Time on ECMO [ Time Frame: Up to Day 28 ]
    Total time on ECMO will be reported.

  20. Percentage of Alive Participants at Day 28, Week 8 and Week 16 [ Time Frame: Day 28, Week 8 and Week 16 ]
    Percentage of alive participants at Day 28, Week 8 and Week 16 will be reported.

  21. Percentage of Alive Participants that Required Readmission at Week 8 and Week 16 [ Time Frame: Week 8 and Week 16 ]
    Percentage of alive participants that required readmission (if previously discharged) at Week 8 and Week 16 will be reported.

  22. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 16 ]
    A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized
  • Has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by real time-polymerase chain reaction (PCR) or any other commercial or public health assay, at any time before randomization
  • Evidence of infiltrates by chest X-ray, chest computed tomography (CT) or chest auscultation (rales, crackles)
  • Informed consent must be obtained from the participant indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • SEVERE OR CRITICAL COVID-19 DISEASE: Severe disease: requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device. Critical disease: Requires supplemental oxygen delivered by nonrebreather mask or high-flow nasal cannula or use of non-invasive or invasive ventilation or requiring treatment in an intensive care unit.

AND at least one of the following: requiring supplemental oxygen delivered at a flow greater than or equal to (>=) 6 liter per minute (L/min) to sustain a peripheral capillary oxygen saturation (SpO2) greater than (>) 93 percent (%) regardless of device/route used, OR partial pressure of oxygen in arterial per percentage of inspired oxygen (PaO2/FiO2) ratio < 300 millimeter of mercury (mmHg) while on invasive mechanical ventilation

Exclusion Criteria:

  • On invasive mechanical ventilation for >24 hours at time of screening
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned dose of study intervention. Note: the investigator must ensure that the participant is not enrolled in another COVID-19 study with an investigational intervention (apart from the exception specified below) prior to completion of Day 28 of the current study. Exception: participation in a single arm study or compassionate use study is allowed if it is conducted with one of the agents with demonstrated in vitro-effect against SARSCoV- 2, as mentioned in the center of disease control and prevention (CDC) guidelines
  • Currently active, clinically significant cardiovascular abnormalities, such as left ventricular ejection fraction <40% documented by cardiac echo within the previous 12 months, signs of pulmonary embolus, hemodynamic significant pericardial effusion, myocarditis, or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification AND/OR Evidence of active cardiac ischemia or history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months prior to randomization
  • Has a history of severe chronic obstructive pulmonary disease (COPD) or other severe chronic condition (that is, asthma, cystic fibrosis, fibrotic lung disease) for which the degree of severity is defined as systemic steroid dependent or that requires home oxygen supplementation, supportive non-invasive ventilation, is status/post lung volume reduction surgery (LVRS), or has known forced expiratory volume (FEV) less than (<) 50%
  • On renal replacement therapy (defined as peritoneal dialysis or hemodialysis)
  • Screening laboratory test result as follows: absolute neutrophil count (ANC) <2.0*10^3 cells/microliter; Platelet count <100*10^3 cells/microliter; estimated glomerular filtration rate (eGFR) <=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2); Bilirubin >2* upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; alanine aminotransferase/ aspartate aminotransferase (ALT/AST) >5*ULN; Prothrombin time (PT)/international normalized ratio (INR) >1.5*ULN or activated partial thromboplastin time (aPTT) >1.5*ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
  • Pregnant or breastfeeding, unless in the opinion of the investigator, the benefit outweighs the risks
  • Has active hepatitis B or C infection or human immunodeficiency virus infection or acquired immune deficiency syndrome (HIV/AIDS) based on medical history and/or concomitant medication
  • Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB based on medical history and/or concomitant medication
  • Evidence of active bacterial (including but not limited to bacterial pneumonia), fungal, viral or opportunistic infection (other than SARS-CoV-2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380961


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
University of Illinois College of Medicine at Peoria Not yet recruiting
Peoria, Illinois, United States, 61637
United States, Kentucky
Kentuckiana Pulmonary Associates Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70012
United States, Michigan
Wayne State University/Detroit Medical Center Not yet recruiting
Detroit, Michigan, United States, 48201-2153
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Beaumont Health Systems Recruiting
Royal Oak, Michigan, United States, 48073
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, Montana
Mercury Street Medical Group, PLLC Recruiting
Butte, Montana, United States, 59701
United States, New Jersey
Saint Michael's Medical Center - Infectious Disease Recruiting
Newark, New Jersey, United States, 07102
United States, New York
SUNY Upstate Medical University Not yet recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
East Carolina University Not yet recruiting
Greenville, North Carolina, United States, 27834
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium
Additional Information:
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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT04380961    
Other Study ID Numbers: CR108820
CNTO136COV2001 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases