A Multi-Centric, Randomized, Double-Blind, Placebo-controlled, Phase-III Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent to be Used as an Adjuvant to Standard Treatment of Hypovolemic Shock

NCT05251181 Phase 3 NOT_YET_RECRUITING

This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. It is a state of cellular and tissue hypoxia due to reduced oxygen delivery and/or increased oxygen consumption or inadequate oxygen utilization. Shock most commonly occurs when there is circulatory failure leading to reduced tissue perfusion. There are four types of shock: distributive, cardiogenic, hypovolemic, and obstructive. However, these are not exclusive, and many patients with circulatory failure have a combination of more than one form of shock (multifactorial shock).

Details

Lead sponsor	Pharmazz, Inc.
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	430
Start date	2026-02
Completion	2027-10

Conditions

• Hypovolemic Shock

Interventions

• Normal Saline
• Centhaquine

Primary outcomes

• Proportion of subjects with all-cause mortality [Time frame: Day 0 through day 28]. — Day 0 through day 28
  Incidence of mortality