Covid 19 Research using Clinical Trials (Home Page)
ClazakizumabWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1162 | Thromboprophylaxis Wiki | 0.71 |
| drug149 | Best standard of care Wiki | 0.71 |
| drug244 | Candesartan Wiki | 0.71 |
| drug646 | Lopinavir/Ritonavir Wiki | 0.71 |
| drug1358 | non-RAS blocking antihypertensives Wiki | 0.71 |
| drug971 | Rivaroxaban Wiki | 0.71 |
| drug1374 | placebo for clazakizumab Wiki | 0.71 |
| drug267 | Chloroquine or Hydroxychloroquine Wiki | 0.50 |
| drug850 | Placebo Wiki | 0.06 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007239 | Infection NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.03 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 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 evaluationSecondary Outcomes
Description: The scale described in the primary endpoint is used
Measure: Time to improvement on WHO Scale Time: Inclusion to day 29, daily evaluationDescription: 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 evaluationDescription: 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 evaluationDescription: 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 evaluationMeasure: 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 evaluationMeasure: 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 evaluationMeasure: 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 evaluationMeasure: 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 29Description: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 evaluationDescription: 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 evaluation2 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 daysSecondary Outcomes
Measure: Cumulative Incidence of Intubation Time: 14 daysMeasure: 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 daysDescription: Number of participants alive at day 60, end of study.
Measure: Patient Survival Time: 60 daysMeasure: 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