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In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a double-blinded randomized multi-center trial designed as a phase II dose-finding three arm trial with seamless adaptive transition to a phase III efficacy trial. For phase II, patients were randomized 1:1:1 ratio to three study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo.
Based on interim analysis, the low dose arm was dropped and the phase III portion of the study continued to enroll patients randomized 1:1 to high dose clazakizumab or placebo.
Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a 1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU site will serve as the central data management site for other centers who undertake this protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60 patients at outside sites are expected to enroll.
The limited understanding of the clinical behavior of patients infected with SARS-CoV-2 (the viral organism responsible for COVID-19 disease) is evolving on a daily basis. Reports from China indicate that a subset of patients with the worst clinical outcomes may manifest cytokine storm syndrome. Hypotheses that excess cytokines may trigger a secondary hemophagocytic lymphhistiocytosis (sHLH) have been proposed. Indeed, cytokine profiles consistent with this picture were observed in Chinese patients with severe pulmonary involvement. Specifically, elevated ferritin and interleukin-6 (IL-6) were associated with fatalities among the infected patients. A role for targeted anti-inflammatory and anti-cytokine therapies in the treatment of pulmonary hyperinflammation has been proposed.
Clazakizumab is a genetically engineered humanized IgG1 monoclonal antibody (mAb) that binds with high affinity to human IL-6. This investigational agent is currently being studied as a treatment for chronic active antibody mediated rejection of renal allografts.
In this study investigators propose to administer clazakizumab to patients with life-threatening pulmonary failure secondary to COVID-19 disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clazakizumab 25 mg | Experimental |
| |
| Clazakizumab 12.5 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clazakizumab 25 mg | Drug | The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Free Survival | Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days. | 28 days |
| Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Patient Survival | Overall Patient Survival is defined as the total number of patients per group who were alive at 28 days | 28 days |
| Overall Patient Survival | Overall patient survival is defined as total number of patients per group who were alive at 60 days. |
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Inclusion Criteria:
In order to be eligible to participate in this study, the patients must meet all of the following criteria:
At least 18 years of age
Confirmed COVID-19 disease (by Cobas SARS-CoV-2 real time RT-PCR using nasopharyngeal swab sample, or equivalent test available to be performed by the NYU Langone clinical laboratory). Effort will be made to have the confirmatory test result <72 hours prior to enrollment however given overall clinical demand this may not be feasible in all cases.
Respiratory failure manifesting as: Acute Respiratory Distress Syndrome (defined by a P/F ratio of <200), OR SpO2 < 90% on 4L (actual or expected given higher O2 requirement) OR increasing O2 requirements over 24 hours, PLUS 2 or more of the following predictors for severe disease:
CRP > 35 mg/L Ferritin > 500 ng/mL D-dimer > 1000 mg/mL Neutrophil-Lymphocyte Ratio > 4 LDH > 200 U/L Increase in troponin in patient w/out known cardiac disease
Has a consent designee willing to provide informed consent on behalf of the patient (this assumes that a mechanically ventilated patients lacks capacity to consent on his/her own behalf. Should it be deemed that the patient has capacity to consent, consent may be obtained from the patient.)
Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period of 5 months following the study drug administration. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:
Men must be willing to use a double-barrier contraception from enrollment until at 5 months after the last dose of study drug, if not abstinent.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Lonze, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| The Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35583232 | Derived | Lonze BE, Spiegler P, Wesson RN, Alachkar N, Petkova E, Weldon EP, Dieter RA, Li Y, Quinn M, Mattoo A, Soomro I, Cohen SM, Leung S, Deterville CL, Landrum BM, Ali MI, Cohen DJ, Singer AL, Sen A, Chong E, Hochman JS, Troxel AB, Montgomery RA. A Randomized Double-Blinded Placebo Controlled Trial of Clazakizumab for the Treatment of COVID-19 Pneumonia With Hyperinflammation. Crit Care Med. 2022 Sep 1;50(9):1348-1359. doi: 10.1097/CCM.0000000000005591. Epub 2022 May 17. |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Upon reasonable request by an investigator who proposes to use the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clazakizumab 25 mg | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2020 |
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This is a randomized, double-blind, placebo-controlled, adaptive seamless Phase II/III design (ASD). We propose the administration of an investigational drug in patients with high predicted short-term mortality secondary to COVID-19 disease. 80 patients were randomly assigned in a 1:1:1 ratio to three study arms that will receive clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Interim analyses occurred every 7 days since the enrollment of the first 30 patients. Based on week 4 interim analysis the DSMB has recommendation discontinuing the low-dose 12.5 mg of clazakizumab arm. The DSMB has advised continuing enrollment in the placebo and high-dose 25mg of clazakizumab arms in a 1:1 randomization.
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This study is double-blind and therefore neither the Investigator, the subject, the Sponsor and its representatives, nor other designated study site personnel involved in running of the study will be aware of the identification of the investigational drug administered to each subject.
|
| Clazakizumab 12.5 mg | Drug | The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. |
|
| Placebo | Other | The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
|
| 60 days |
| Number of Participants With Change in Clinical Status | Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead | 28 days |
| Number of Participants With a Change in Clinical Status | Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead | 60 days |
| Number of Clazakizumab-expected Adverse Events | 60 days |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| FG001 | Clazakizumab 12.5 mg | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. |
| FG002 | Placebo | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clazakizumab 25 mg | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. |
| BG001 | Clazakizumab 12.5 mg | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. |
| BG002 | Placebo | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventilator Free Survival | Ventilator Free Survival is defined as the total number of patients who were alive and ventilator free at 28 days. | Posted | Count of Participants | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Serious Adverse Events Associated With High and Low Dose of Clazakizumab | Posted | Number | Serious Adverse Events | 60 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Patient Survival | Overall Patient Survival is defined as the total number of patients per group who were alive at 28 days | Posted | Count of Participants | Participants | 28 days |
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Patient Survival | Overall patient survival is defined as total number of patients per group who were alive at 60 days. | Posted | Count of Participants | Participants | 60 days |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change in Clinical Status | Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead | Posted | Count of Participants | Participants | 28 days |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Change in Clinical Status | Change in clinical status defined by an improvement in status by at least 2 score points on WHO 11-point ordinal scale, where 0 = uninfected; no viral RNA detected, 1 = asymptomatic; viral RNA detected, 2 = symptomatic; independent, 3 = symptomatic; assistance needed, 4 = hospitalized; no oxygen therapy, 5 = hospitalized; oxygen by mask or nasal prongs, 6 = hospitalized; oxygen by NIV or high flow, 7 = intubation and mechanical ventilation, pO2/FiO2 >/= 150 or SpO2/FiO2 >/= 200, 8 = mechanical ventilation pO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors, 9 = mechanical ventilation pO2/FiO2 < 150 and vasopressors, dialysis, or ECMO, and 10 = Dead | Posted | Count of Participants | Participants | 60 days |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Clazakizumab-expected Adverse Events | Posted | Number | Adverse Events | 60 days |
|
60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clazakizumab 25 mg | Clazakizumab 25 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3. | 22 | 78 | 24 | 78 | 76 | 78 |
| EG001 | Clazakizumab 12.5 mg | Clazakizumab 12.5 mg: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3. | 6 | 26 | 6 | 26 | 24 | 26 |
| EG002 | Placebo | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. | 28 | 74 | 33 | 74 | 72 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| alanine aminotransferase increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| aspartate aminotransferase increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| gastric hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| hypermagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypotension | General disorders | Non-systematic Assessment |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| infections | Infections and infestations | Non-systematic Assessment |
| ||
| intracranial hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| lower respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| lymphocyte count increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| multi-organ failure | General disorders | Non-systematic Assessment |
| ||
| muscle weakness | Nervous system disorders | Non-systematic Assessment |
| ||
| platelet count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| visceral arterial ischemia | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| alanine aminotransferase increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| alkaline phosphatase increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| alopecia | General disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Ankle fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Aphonia | Nervous system disorders | Non-systematic Assessment |
| ||
| aspartate minotransferase increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Non-systematic Assessment |
| ||
| blood bicarbonate decreased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| blood bilirubin increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Blurred vision | Nervous system disorders | Non-systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| bronchopulmonary hemorrahge | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| cardiac troponin increased | Cardiac disorders | Non-systematic Assessment |
| ||
| chest pain-cardiac | Cardiac disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| cognitive disturbance | Nervous system disorders | Non-systematic Assessment |
| ||
| Confusion | Nervous system disorders | Non-systematic Assessment |
| ||
| creatinine increased | Renal and urinary disorders | Non-systematic Assessment |
| ||
| cystitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| cytomegalovirus infection | Infections and infestations | Non-systematic Assessment |
| ||
| dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| delirium | Nervous system disorders | Non-systematic Assessment |
| ||
| depressed level of consciousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| disseminated intravascular coagulation | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| dysphagia | Nervous system disorders | Non-systematic Assessment |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| encephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| eosinophilia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| epistaxis | General disorders | Non-systematic Assessment |
| ||
| fall | General disorders | Non-systematic Assessment |
| ||
| fever | General disorders | Non-systematic Assessment |
| ||
| fibrinogen decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| fungemia | Infections and infestations | Non-systematic Assessment |
| ||
| gastric hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| hearing impaired | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| hematoma | General disorders | Non-systematic Assessment |
| ||
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| hepatic necrosis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| hepatobiliary disoders, other | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| herpes simplex reactivation | Infections and infestations | Non-systematic Assessment |
| ||
| hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hyperlipidemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypermagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hyperphosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypertension | General disorders | Non-systematic Assessment |
| ||
| hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| hypotension | General disorders | Non-systematic Assessment |
| ||
| hypothermia | General disorders | Non-systematic Assessment |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| inr increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| intracranial hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| lethargy | Nervous system disorders | Non-systematic Assessment |
| ||
| lower gastrointestinal hemorrahge | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| lower respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| lymphocyte count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| maculopapular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| muscle weakness | Nervous system disorders | Non-systematic Assessment |
| ||
| nasal congestion | General disorders | Non-systematic Assessment |
| ||
| neutrophil count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| non-cardiac chest pain | General disorders | Non-systematic Assessment |
| ||
| oral hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| pericardial effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| peripheral ischemia | Vascular disorders | Non-systematic Assessment |
| ||
| peripheral motor neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Platelet Count Decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| presyncope | Nervous system disorders | Non-systematic Assessment |
| ||
| proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| renal calculi | Renal and urinary disorders | Non-systematic Assessment |
| ||
| retroperitoneal hemhorrahge | General disorders | Non-systematic Assessment |
| ||
| right ventricular dysfunction | Cardiac disorders | Non-systematic Assessment |
| ||
| seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| skin & subcutaneous tissue disorders | Infections and infestations | Non-systematic Assessment |
| ||
| skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| skin ulceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| soft tissue infection | Infections and infestations | Non-systematic Assessment |
| ||
| soft tissue necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| sore throat | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| subcutaneous emphysema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| tachypnic | Cardiac disorders | Non-systematic Assessment |
| ||
| thromboembolic event | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| thrush | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| tracheal hemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| triglycerides increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| upper gastrointestinal hemorrahge | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| weight loss | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| multi-organ failure | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Lonze, MD, PhD | NYU Langone Health | 212-263-3865 | bonnie.lonze@nyulangone.org |
| Feb 4, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604955 | clazakizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
|
|
Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
|
|
| OG002 | Placebo | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
|
|
| OG002 | Placebo | Placebo: The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3. |
|
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|