Status:
NOT_YET_RECRUITING
Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in Patients With ARDS
Lead Sponsor:
Pharmazz, Inc.
Conditions:
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Acute respiratory distress syndrome (ARDS) is a life-threatening condition with a diffuse, inflammatory form of lung injury, causing pulmonary infiltration and respiratory failure leading to poor oxyg...
Detailed Description
This is a multicentric, randomized, double-blind, placebo-controlled phase-II clinical study to assess the safety and efficacy of centhaquine as an adjuvant to the standard of care in patients with mo...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in the study if he/she fulfills the following criteria:
- Adult male or female aged 18 years or older
- Hospitalized in the ICU diagnosed with moderate to severe ARDS having a PaO2/FiO2 ratio of \< 200 mmHg or the SPO2/FiO2 ratio of ≤ 235( if SPO2 ≤ 97 %) with PEEP ≥ 5 cm H20 include the patient receiving invasive /non-invasive ventilation (NIV/CPAP).
- The first dose of the study drug should be administered within 48 hours of confirming moderate to severe ARDS.
- Requires vasopressor support
- Written informed consent
Exclusion
- A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
- Receiving or expected to receive extracorporeal membrane oxygenation or high-frequency oscillatory ventilation
- Confirmed pregnancy
- Breast feeding
- Participating in another interventional study
- Requires or having the renal replacement therapy
- Hepatic failure (Child-Pugh scores B and C)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05241067
Start Date
December 1 2025
End Date
December 31 2026
Last Update
October 17 2025
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