Covid 19 Research using Clinical Trials (Home Page)
Zilucoplan®Wiki
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There is one clinical trial.
Clinical Trials
1 A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Complement C5 Inhibition With Zilucoplan® in Improving Oxygenation and short-and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure
The study is a randomized controlled, open-label trial comparing subcutaneous Zilucoplan® with standard of care to standard of care alone. In the active group, Zilucoplan® will be administered subcutaneously once daily for 14 days or till discharge from the hospital, whichever comes first. The hypothesis of the proposed intervention is that Zilucoplan® (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. This hypothesis is based on experiments performed in mice showing that C5a blockade can prevent mortality and prevent ARDS in mice with post-viral acute lung injury. Eligible patients include patients with confirmed COVID-19 infection suffering from hypoxic respiratory failure defined as O2 saturation below 93% on minimal 2l/min O2 therapy and/or ratio PaO2/FiO2 below 350.
NCT04382755 COVID-19 Drug: Zilucoplan® Drug: Placebo MeSH:Respiratory Insufficiency
Primary Outcomes
Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio
Measure: Mean change in oxygenation Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio
Measure: Median change in oxygenation Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)Secondary Outcomes
Measure: number of AE's (Adverse Events) Time: during hospital admission (up to 28 days)Measure: number of SAE's (Serious Adverse Events) Time: during hospital admission (up to 28 days)]
Description: 6-point ordinal scale defined as Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: mean change in 6-point ordinal scale change Time: between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call).Description: defined as independence from supplemental oxygen
Measure: Time since randomization until improvement in oxygenation Time: during hospital admission (up to 28 days)Description: defined as SpO2 < 93% breathing room air or the dependence on supplemental oxygen
Measure: Number of days with hypoxia Time: during hospital admission (up to 28 days)Measure: Number of days of supplemental oxygen use Time: during hospital admission (up to 28 days)
Measure: Time to absence of fever (defined as 37.1°C or more) for more than 48h without antipyretic Time: during hospital admission (up to 28 days)
Description: defined as 37.1°C or more
Measure: Number of days with fever Time: during hospital admission (up to 28 days)Measure: Time to halving of CRP levels to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Time to halving of ferritin levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Incidence of AE's Time: during hospital admission (up to 28 days)
Measure: Incidence of SAE's Time: at 10-20 weeks follow-up
Measure: Incidence of SUSAR's (Suspected Unexpected Serious Adverse Reaction) Time: during hospital admission (up to 28 days)
Measure: Incidence of SAR's (Serious Adverse Reaction) Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay in survivors Time: during hospital admission (up to 28 days)
Description: Clinical sign score: 0( best) - 18 (worse)
Measure: Mean change in clinical sign score between day 1 and day 6 Time: day 1, day 6 or on discharge, whichever is firstDescription: Clinical sign score: 0( best) - 18 (worse)
Measure: Mean change in clinical sign score between day 1and day 15 (or on discharge, whichever is first) Time: day 1, day 15 or on discharge, whichever is firstDescription: Clinical sign score: 0( best) - 18 (worse)
Measure: Mean change in clinical sign score between day 1 and day 28 (or on discharge, whichever is first) Time: day 1, day 28 or on discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score between day 1 and day 6 (or on discharge, whichever is first) Time: day 1, day 6 or on discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score between day 1 and day 15 or on discharge, whichever is first) Time: day 1, day 15 or on discharge, whichever is firstDescription: NEWS2 score: 0 (best) - 24 (worse)
Measure: Mean change NEWS2 (National Early Warning) score between day 1 and day 6 Time: day 1, day 6 or on discharge, whichever is firstDescription: NEWS2 score: 0 (best) - 24 (worse)
Measure: Mean change NEWS2 (National Early Warning) score between day 1 and day 15 Time: day 1, day 15 or on discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale at randomization, day 6 and 15 (or discharge, whichever comes first) and day 28 (phone call) Time: day 1, day 6, day 15 (or discharge, whichever comes first)Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: 6-point Ordinal Scale at 6 and 15 days (or discharge whichever comes first) and day 28 (phone call), in relation to serum D-dimers and complement C5a levels at randomization Time: day 1, day 6, day 15 (or discharge, whichever comes first)Measure: Incidence of nosocomial bacterial or invasive fungal infection for 28 days (phone call) after enrolment in trial Time: day 28
Description: defined by Hs (Hemophagocytic Syndrome) score
Measure: incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum D-dimers and complement C5a at randomization Time: day 1, day 6, day 15 (or discharge, whichever comes first)Measure: Time since randomization until first use of high-flow oxygen devices in non-ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time since randomization until first use of non-invasive mechanical ventilation in non-ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time since randomization until first use of invasive mechanical ventilation in non-ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time since to first use of salvage systemic steroids in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Number of ventilator-free days Time: day 1, day 28 or discharge whichever comes first
Measure: Duration of invasive and non-invasive mechanical ventilation in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Duration of ICU stay in patients that enrolled in trial on invasive or non-invasive mechanical ventilation for less than 24h prior to or after randomization Time: during hospital admission (up to 28 days)
Description: criteria-defined ARDS (according to the American-European Consensus Conference (AECC) diagnostic criteria for ARDS: acute onset; ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) of 200mmHg or less, regardless of positive end-expiratory pressure; bilateral infiltrates seen on frontal chest radiograph; and pulmonary artery wedge pressure of 18 mm Hg or less when measured, or no clinical evidence of left atrial hypertension)
Measure: Time since randomization to progression to ARDS (Acute Respiratory Distress Syndrome) in ventilated patients Time: during hospital admission (up to 28 days)Measure: Time to progression to ARDS in ventilated patients according to D-dimers at randomization Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to complement C5a at randomization Time: during hospital admission (up to 28 days)
Measure: All-cause mortality rate (excluding group that entered during ventilation) Time: at day 28
Measure: All-cause mortality rate (including group that entered during ventilation) Time: at day 28
Measure: Percentage of patients in clinical status on 6-point Ordinal Scale Time: at 12-22 weeks follow-up
Description: Clinical sign score: 0( best) - 18 (worse)
Measure: Mean change in clinical sign score between day 1 and follow up 12-22 weeks Time: day 1, follow-up 12-22 weeksMeasure: Incidence of lung function abnormalities at follow Time: at 12-22 weeks follow-up
Measure: Incidence of lung fibrosis on chest CT scan Time: at 12-22 weeks follow-up
Measure: All cause mortality for the entire study population Time: at follow up 12-22 weeks