CLINICAL TRIALS PROFILE FOR CENTHAQUINE
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Clinical Trials for Centhaquine
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT04045327 ↗ | Efficacy of PMZ-2010 (Centhaquine) a Resuscitative Agent for Hypovolemic Shock | Completed | Pharmazz, Inc. | Phase 3 | This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-III efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock. Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary Name (INN) recently approved by WHO is centhaquine) has been found to be an effective resuscitative agent in rat, rabbit and swine models of hemorrhagic shock, it decreased blood lactate, increased mean arterial pressure, cardiac output, and decreased mortality. An increase in cardiac output during resuscitation is mainly attributed to an increase in stroke volume. Centhaquine acts on the venous α2B-adrenergic receptors and enhances venous return to the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic receptors to reduce sympathetic activity and systemic vascular resistance. |
| NCT04056065 ↗ | PMZ-2010 (Centhaquine) as a Resuscitative Agent for Hypovolemic Shock | Completed | Pharmazz, Inc. | Phase 2 | This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-II efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock. Centhaquine is highly safe and well tolerated. Toxicological studies showed high safety margin in preclinical studies. Its safety and tolerability has been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731). |
| NCT05241067 ↗ | Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in COVID-19 Patients With ARDS | Not yet recruiting | Pharmazz, Inc. | Phase 2 | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus causing coronavirus disease 2019 (COVID-19), which has been a global pandemic since March 2020. According to WHO, more than 289 million cases have been confirmed worldwide, with just over 5.4 million reported deaths as of January 2022. SARS-CoV-2 variants continue to emerge, with the omicron variant causing the increased surge in cases. Currently, Johns Hopkins University of Medicine reports a case fatality rate of 1.5% for the United States. COVID-19 infections may be asymptomatic in some cases, while most cases cause mild to moderate illness with respiratory and flu-like symptoms. However, a significant number of COVID-19 cases develop severe life-threatening illness involving severe pneumonia and acute respiratory distress syndrome (ARDS), requiring admission to the intensive care unit (ICU) Although there have been breakthroughs in the treatment for COVID-19, most of these are directed at mild-to-moderate disease rather than patients with severe disease on mechanical ventilators. There is still a need for novel and effective treatment options in severe COVID-19 illness with continued vaccine hesitancy, decreased social distancing, and new emerging variants. Centhaquine is a first-in-class resuscitative agent for the hypovolemic shock that is approved for marketing in India. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647). Clinical phase II (CTRI/2017/03/008184) and phase III (CTRI/2019/01/017196) results indicate that centhaquine is a novel first-in-class, highly effective resuscitative agent for hypovolemic shock. Centhaquine provided hemodynamic stability and significantly improved acute respiratory distress syndrome (ARDS) and multiple organ dysfunction score (MODS) in clinical trials conducted in India. A total of 155 patients with hypovolemic shock have been studied (combined phase II and III). Centhaquine is safe and reduced the mortality from 10.71% in patients receiving standard treatment to 2.20% in patients that received centhaquine (odds ratio 5.340; 95% CI 1.270-26.50; P=0.0271). In a phase 3 study of hypovolemic shock, ARDS and MODS were secondary endpoints, and centhaquine reduced both with a significant p-value. |
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