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ClazakizumabWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (14)

Name (Synonyms) Correlation
drug2346 RS blend Wiki 0.41
drug3410 placebo for clazakizumab Wiki 0.41
drug2917 Thromboprophylaxis Wiki 0.41
drug609 Candesartan Wiki 0.41
drug1377 IgG Wiki 0.41
drug2307 Quantra System Wiki 0.41
drug400 Best standard of care Wiki 0.41
drug3375 non-RAS blocking antihypertensives Wiki 0.41
drug660 Chloroquine or Hydroxychloroquine Wiki 0.24
drug1601 Lopinavir/Ritonavir Wiki 0.24
drug1922 Normal saline Wiki 0.18
drug2458 Rivaroxaban Wiki 0.18
drug2122 Placebo Wiki 0.08
drug2311 Questionnaire Wiki 0.08

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D020141 Hemostatic Disorders NIH 0.22
D001778 Blood Coagulation Disorders NIH 0.22
D004211 Disseminated Intravascular Coagulation NIH 0.20
D012769 Shock, NIH 0.17
D007239 Infection NIH 0.06
D003141 Communicable Diseases NIH 0.03
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0001928 Abnormality of coagulation HPO 0.22
HP:0005521 Disseminated intravascular coagulation HPO 0.20

There are 6 clinical trials

Clinical Trials

1 A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.

NCT03744910 Antibody-mediated Rejection Biological: Clazakizumab Drug: Normal saline

Primary Outcomes

Description: The aim of this study is to follow enrolled participants until 221 occurrences of all-cause allograft loss, defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause have been observed. The analysis will be a stratified log rank test of the effect of treatment on all-cause composite allograft loss, with stratification factors of dichotomized baseline eGFR (25-45 mL/min/1.73 m2 versus >45-65 mL/min/1.73 m2), baseline proteinuria, treatment for early (within 6 months of transplant) ABMR rejection episodes (yes/no), and treatment for late (greater than 6 months post transplant) ABMR rejection episodes (yes/no). Surviving subjects without allograft loss will be censored at the time of their last assessment.

Measure: Incidence of all cause composite allograft loss

Time: Five years

2 A Phase II Trial to Evaluate the Safety and Tolerability of Clazakizumab® (Anti-IL- 6 Monoclonal) Compared to Placebo for the Treatment of COVID-19 Infection

This is a single center, randomized, double-blind, placebo-controlled, exploratory phase II study enrolling 60 patients. We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo[0.9% saline]) in patients with COVID-19 disease and signs of pulmonary involvement who have not yet required mechanical ventilation and/or ECMO. If a patient progresses to mechanical ventilation and/or ECMO or develops clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious adverse events(SAEs), within the initial 14 day period after the first dose of the IP, at the discretion of the investigator or treating physician, open-label clazakizumab 25mg IV X 1 dose may be administered. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. The patient will remain blinded as to the identity of the IP administered in the first dose.

NCT04348500 COVID19 Drug: Clazakizumab

Primary Outcomes

Description: Incidence of adverse events that are unusual, unexpected, or assessed as related to the IP

Measure: Evaluate the safety of clazakizumab for the treatment of patients with COVID-19 disease and signs of pulmonary involvement

Time: 14 days

Secondary Outcomes

Description: Number of patients alive at 28 days

Measure: Patient survival at 28 days

Time: 28 days

Description: Number of patients alive at 60 days

Measure: Patient survival at 60 days

Time: 60 days

Description: Number of patients requiring the dose of open-label clazakizumab

Measure: Number of patients requiring the dose of open-label clazakizumab

Time: 14 days

Description: Number of days in ICU compared to placebo

Measure: Reduced duration of intensive care unit stay

Time: 60 days

Description: Number of days in hospital compared to placebo

Measure: Reduced duration of hospital stay

Time: 60 days

Description: Incidence of need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo

Measure: Reduced need for ventilation

Time: 14 days

3 A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)

The Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine, lopinavir/ritonavir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure >120/80mmHg), and substudy C (clazakizumab vs standard of care, for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.

NCT04351724 COVID-19 Drug: Chloroquine or Hydroxychloroquine Drug: Lopinavir/Ritonavir Other: Best standard of care Drug: Rivaroxaban Drug: Thromboprophylaxis Drug: Candesartan Drug: non-RAS blocking antihypertensives Drug: Clazakizumab Drug: placebo for clazakizumab
MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary endpoint is time to clinical improvement which is defined as time from randomization to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomization measured on a seven-category ordinal scale (proposed by WHO). The 7-categories of the World Health Organization proposed scale, as follows: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death. During hospitalization this score will be determined daily (till day 29). If a patient is released from the hospital before day 29, the score will be determined at day 11 and 29 after randomization (depending when the patient was released or by telephone call).

Measure: sustained improvement (>48h) of one point on the WHO Scale

Time: Inclusion to day 29, daily evaluation

Secondary Outcomes

Description: The scale described in the primary endpoint is used

Measure: Time to improvement on WHO Scale

Time: Inclusion to day 29, daily evaluation

Description: The scale described in the primary endpoint is used

Measure: Mean change in the ranking on an ordinal scale from baseline

Time: Inclusion to day 29, daily evaluation

Description: the National Early Warning Score includes respiratory rate, oxygen saturation, use of supplemental oxygen, temperature, systolic blood pressure, heart rate and levels of consciousness (AVPU Scale)

Measure: time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first

Time: Inclusion to day 29, daily evaluation

Description: The scale described in the primary endpoint is used

Measure: change from baseline in National Early Warning Score (NEWS)

Time: Inclusion to day 29, daily evaluation

Measure: Oxygenation free days

Time: Inclusion to day 29, daily evaluation

Description: new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation

Measure: Incidence of new oxygen use during the trial

Time: Inclusion to day 29, daily evaluation

Measure: duration of oxygen use during the trial

Time: Inclusion to day 29, daily evaluation

Description: number of days with requirement of mechanical ventilation

Measure: Ventilator free days until day 29

Time: Inclusion to day 29, daily evaluation

Measure: Incidence of new mechanical ventilation use during the trial

Time: Inclusion to day 29, daily evaluation

Measure: duration of mechanical ventilation use during the trial

Time: Inclusion to day 29, daily evaluation

Description: obtained by polymerase chain reaction in nasal/oropharyngeal swabs, performed at baseline and then three times a week, if possible

Measure: Viral load/viral clearance

Time: Inclusion to day 29, daily evaluation

Measure: Duration of Hospitalization

Time: Inclusion to day 29, daily evaluation

Measure: Mortality

Time: 15-day, 29-day mortality

Description: BMI (kg/m2), within all subjects the impact of obesity on overall mortality will be investigated

Measure: Obesity - mortality

Time: BMI at admission, mortality until day 29

Description: BMI (kg/m2) , within all subjects the impact of obesity on the duration of hospitalization will be investigated

Measure: Obesity - duration of hospitalization

Time: BMI at admission, duration of hospitalization until day 29 or discharge

Description: BMI (kg/m2) , within all subjects the impact of obesity on ICU admission will be investigated

Measure: Obesity - ICU admission

Time: BMI at admission, ICU admission until day 29 or discharge

Description: BMI (kg/m2) new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation

Measure: Obesity - new oxygen use

Time: BMI at admission, new oxygen use until day 29 or discharge

Description: lopinavir and ritonavir both interact with numerous other drugs by inhibiting the cytochrome enzymes 3A4. Using commercially available drug-interaction programs, the number and severity grading of drug-drug-interactions will be documented (for instance uptodate interaction tool, medscape). This is an exploratory analysis of drug-drug interactions with the above mentioned substances. severity grading usually encompass "contraindicated", "serious", "monitor closely", "minor" interaction.

Measure: Drug-drug interactions with lopinavir/ritonavir

Time: Inclusion to day 29, daily evaluation

Description: for sub-study B only: RAS fingerprint measures metabolites involved in the renin-angiotensin-system. The influence of randomized treatment with candesartan (RAS blockade) will be analyzed

Measure: Renin Angiotensin System (RAS) fingerprint

Time: Inclusion to day 29, daily evaluation

4 A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

In this study Investigators 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 single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.

NCT04363502 COVID Drug: Clazakizumab Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Serum CRP (measured in mg/dl) will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response

Measure: Change in C-reactive protein (CRP) level

Time: Up to 3 days

5 A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.

NCT04381052 COVID-19 Drug: Clazakizumab Other: Placebo
MeSH:Infection

Primary Outcomes

Measure: Cumulative incidence of serious adverse events associated with clazakizumab or placebo

Time: 60 days

Secondary Outcomes

Measure: Cumulative Incidence of Intubation

Time: 14 days

Measure: Time to Extubation

Time: 14 days

Measure: Length of Intensive Care Unit (ICU) stay

Time: 14 days

Measure: Number of Patients who Present a Decrease in C-reactive protein (CRP)

Time: 14 days

Measure: Number of Patients with Acute Kidney Injury (AKI)

Time: 14 days

Measure: Number of Patients with a Need for Renal Replacement Therapy (RRT)

Time: 14 days

Measure: Duration of Renal Replacement Therapy (RRT)

Time: 60 days

Description: Number of participants alive at day 28.

Measure: Patient Survival

Time: 28 days

Description: Number of participants alive at day 60, end of study.

Measure: Patient Survival

Time: 60 days

Measure: Number of Patients with Hemodialysis

Time: 60 days

Measure: Number of Patients with Continuous Renal Replacement Therapies (CRRT)

Time: 60 days

Measure: Number of Patients with Peritoneal Dialysis

Time: 60 days

6 A Phase 2 Trial to Evaluate the Safety and Tolerability of Clazakizumab® [Anti-Interleukin (IL)-6 Monoclonal] Compared to Placebo for the Treatment of COVID-19 Infection

The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.

NCT04494724 COVID-19 Infection Drug: Clazakizumab Drug: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Proportion of participants who experience treatment-related adverse events (TEAE) ≥ Grade 3 (CTCAE v5.0) during the first 24 hours after infusion of clazakizumab or placebo

Measure: Primary Endpoint

Time: 24 hours

Secondary Outcomes

Description: Proportion of participants who need mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) after the first dose of clazakizumab or placebo

Measure: Requirement for mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO)

Time: 14 days

Description: Proportion of participants who experience infusion-related reactions during the first 24 hours after infusion of clazakizumab or placebo

Measure: Infusion-related reactions during 24 hours from the time of infusion

Time: 24 hours

Description: Proportion of participants alive at day 28 after the first dose of clazakizumab or placebo

Measure: Patient survival at 28 days

Time: 28 days

Description: Proportion of participants alive at day 60 after the first dose of clazakizumab or placebo

Measure: Patient survival at 60 days

Time: 60 days

Description: Proportion of participants who require an open-label dose of clazakizumab

Measure: Requirement for open-label clazakizumab

Time: 14 days

Description: Number of days in the ICU following the first dose of clazakizumab or placebo

Measure: Time in the intensive care unit (ICU)

Time: 60 days

Description: Number of days in the hospital following the first dose of clazakizumab or placebo

Measure: Time in the hospital

Time: 60 days

Description: Number of days from first dose of clazakizumab or placebo to requiring mechanical ventilation

Measure: Time to mechanical ventilation

Time: 60 days

Description: Difference in WHO Clinical Progression Scale between clazakizumab and placebo

Measure: Clinical status improvement assessed by the World Health Organization (WHO) Clinical Progression Scale at day 14

Time: 14 days

Description: Difference in WHO Clinical Progression Scale between clazakizumab and placebo

Measure: Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28

Time: 28 days

Description: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 14 from baseline between clazakizumab or placebo

Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 14

Time: 14 days

Description: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 28 from baseline between clazakizumab or placebo

Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 28

Time: 28 days

No related HPO nodes (Using clinical trials)