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

NCT04380961 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR108820CNTO136COV20012020-003056-32
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 16

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.

Conditions

Critical Confirmed Coronavirus Disease (COVID)-19

Outcome Measures

Primary Outcomes (1)

• Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal Clinical Recovery Scale (CRS): Primary Analysis Set

  Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxygen (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 (IMV) or extracorporeal membrane oxygenation (ECMO) (category 5); death (category 6). Higher scores indicated greater worsening.

  Up to Day 28

Secondary Outcomes (27)

• Percentage of Participants With an Improvement of At Least 2 Categories Compared to Baseline on 6-point Ordinal CRS

  Day 28

• Percentage of Participants With All-cause Mortality Up to 28 Days

  Up to 28 days

• Time to Sustained Improvement of at Least 2 Categories on 6-point Ordinal CRS: Intent-to-Treat (ITT) Set

  Up to Day 28

• Percentage of Participants With an Improvement of at Least 2 Categories Compared to Baseline on 6-point Ordinal CRS: ITT Set

  Day 28

• Percentage of Participants With All-cause Mortality: ITT Set

  Day 28

Study Arms (2)

Sirukumab

EXPERIMENTAL

Participants will receive single intravenously (IV) dose infusion of sirukumab on Day 1 along with standard of care treatment.

Drug: Sirukumab; Other: Standard of Care (SOC)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Other: Standard of Care (SOC)

Interventions

Sirukumab DRUG

Participants will receive single dose infusion of sirukumab on Day 1.

Also known as: CNTO136

Sirukumab

Placebo DRUG

Participants will receive placebo IV single dose infusion on Day 1.

Placebo

Standard of Care (SOC) OTHER

SOC treatment will be determined by the investigator based on local practice and consists of supportive care.

Placebo; Sirukumab

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized
• Has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by real time-polymerase chain reaction (PCR) at any time before randomization
• Evidence of infiltrates by chest X-ray, chest computed tomography (CT), lung ultrasound, 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
• Critical COVID-19 disease, defined as: 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 corresponding to category 4 on the 6-point ordinal recovery scale, that is: requires one of the above modalities to sustain a peripheral capillary oxygen saturation (SpO2) greater than (\>) 93 percent (%) with a fraction of inspired oxygen (FiO2) of 50% or higher. Note, the use of other devices may fit with category 4 if the FiO2 is 50% or higher.
• OR, corresponding to category 5 on the 6-point ordinal recovery scale, that is partial pressure of oxygen in arterial per percentage of inspired oxygen (PaO2/FiO2) ratio \< 300 millimeter of mercury (mmHg) while on invasive mechanical ventilation or veno-venous extracorporeal membrane oxygenation (ECMO) for less than 48 hours prior to screening

You may not qualify if:

• On invasive mechanical ventilation or on veno-venous ECMO for \>48 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, a non-blinded controlled study, expanded access, compassionate use program or any other program that is not a blinded study is allowed if it is conducted with one of the following: agents with demonstrated in vitro-effect against SARSCoV- 2, as mentioned in the center of disease control and prevention (CDC) guidelines and convalescent plasma
• Current confirmed or high suspicion for 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 Current evidence of active cardiac ischemia
• Has a history of respiratory condition (that is, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, fibrotic lung disease) that requires home oxygen supplementation, supportive non-invasive ventilation or, is status/post lung volume reduction surgery (LVRS). Exception: Participants with sleep apnea using supportive non-invasive ventilation (continuous positive airway pressure \[CPAP\]) at screening may be included
• On renal replacement therapy (defined as peritoneal dialysis or hemodialysis)
• Screening laboratory test result as follows: absolute neutrophil count (ANC) \<1.0\*10\^3 cells/microliter; Platelet count \<50\*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) \>5\*ULN; Prothrombin time (PT)/international normalized ratio (INR) \>1.5\*ULN or activated partial thromboplastin time (aPTT) \>1.5\*ULN related to known coagulopathy or bleeding disorder (the participant can receive anticoagulant therapies for underlying conditions, or as systematic thromboprophylaxis due to COVID-19, or as part of the treatment of complications of COVID-19, but cannot participate in a clinical study with anticoagulants for COVID-19)
• Pregnant or breastfeeding, unless in the opinion of the investigator, the benefit outweighs the risks
• Has active hepatitis B or C infection or has human immunodeficiency virus infection or acquired immune deficiency syndrome (HIV/AIDS) based on medical history and/or concomitant medication
• Known active or latent 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)
• Currently active clinically significant (example, causing hemodynamic instability and/or causing hypoxemia) and uncontrolled arrhythmia

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (16)

MemorialCare Research Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, 33308, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Illinois College of Medicine at Peoria

Peoria, Illinois, 61637, United States

Location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70012, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Beaumont Health Systems

Royal Oak, Michigan, 48073, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Saint Michaels Medical Center - Infectious Disease

Newark, New Jersey, 07102, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, 76104, United States

Location

Related Publications (1)

• Thys K, Loza MJ, Lynn L, Callewaert K, Varma L, Crabbe M, Van Wesenbeeck L, Van Landuyt E, De Meyer S, Aerssens J, Verbrugge I. Pharmacodynamic, prognostic, and predictive biomarkers in severe and critical COVID-19 patients treated with sirukumab. Sci Rep. 2024 Oct 3;14(1):22981. doi: 10.1038/s41598-024-74196-9.

  PMID: 39362933 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sirukumab; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director 1 Study Responsible Physician
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: April 24, 2020
• Primary Completion: April 9, 2021
• Study Completion: June 24, 2021
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

US (16)