Multicentric, Randomized Study to Assess Safety and Efficacy of Centhaquine in Patients With ARDS

April 9, 2026 updated by: Pharmazz, Inc.

A Multicentric, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Centhaquine as an Adjuvant to the Standard of Care in Patients With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS)

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 oxygenation. It is a rapidly progressive form of respiratory failure and accounts for approximately 10% of admissions to the intensive care unit (ICU) and has a high mortality (40%) in severe cases. Globally, approximately 3 million ARDS cases are reported each year, with around 200,000 cases seen in the United States.

The etiology of ARDS could be pulmonary or extra-pulmonary. Patients with ARDS have symptoms like difficulty in breathing, shortness of breath, and cyanosis, and they may require assisted breathing/ventilatory support/extracorporeal membrane oxygenation. About 25% of ARDS patients need mechanical ventilation to support breathing; however, a ventilator-induced lung injury (VILI) is known to further exacerbate ARDS in many of them. In recent decades, numerous efforts have been made to develop therapies for treating/managing ARDS. Unfortunately, they have been largely unsuccessful or inconclusive, and at present, no effective pharmacological therapy for ARDS is available. Hence, development of better therapeutics for ARDS is an unmet need.

Centhaquine is a first-in-class resuscitative agent for hypovolemic shock 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). Results from multicentric, randomized, double-blind, parallel, controlled clinical phase II (CTRI/2017/03/008184) and phase III (CTRI/2019/01/017196) studies conducted in India indicate that centhaquine is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. A total of 155 patients with hypovolemic shock have been studied in the combined phase II and III trials, while a multicentric phase IV study (NCT05956418) in 400 patients with hypovolemic shock is currently being conducted in India. The outcomes of the completed trials indicate that centhaquine is safe and reduces mortality significantly (P=0.0271) compared to standard treatment of hypovolemic shock. In the phase II and III studies, ARDS and MODS were evaluated as secondary endpoints. Centhaquine provided hemodynamic stability and significantly reduced ARDS and multiple organ dysfunction score (MODS) in patients enrolled in these trials, which suggests that centhaquine has potential beyond treating hypovolemic shock and could be useful for ARDS treatment. Centhaquine is likely to provide hemodynamic stability, improve tissue oxygenation, reduce pulmonary edema, reduce ARDS score, and reduce MODS in patients with ARDS.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 moderate to severe ARDS. Approximately 10 study centers in the United States will participate in the study. For an individual patient, the duration of the study will be 60 days, including 3 study visits: visit 1/Day 1 (screening/randomization/baseline/treatment visit), visit 2/Day 28, and visit 3/End of Study (Day 60). At visit 1, approximately 80 eligible patients will be randomized 1:1 into 2 treatment groups of 40 each after meeting the eligibility criteria. A total of 40 patients will be enrolled in the centhaquine group (Group 1) and a total of 40 patients in the control group (Group 2):

  • Group 1 (Active Group): Centhaquine (Dose: 0.01 mg/kg) + Standard of care
  • Group 2 (Control group): Equal volume of Normal Saline + Standard of care In both treatment groups, patients will be provided with the standard of care. Centhaquine or Equal volume of Normal Saline will be administered intravenously after randomization to patients meeting the eligibility criteria. In the centhaquine group, centhaquine (0.01 mg/kg) dose will be administered as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. An additional dose of centhaquine will be administered on Day 2 if oxygenation and/or vasopressor support is required, but not before 24 hours of the previous dose (maximum 2 doses at an interval of 24 hours can be administered). In the control group, equal volume of normal saline will be administered as an intravenous (IV) infusion over 1 hour post-randomization. Conditions of administration will remain the same as for the centhaquine group. All subjects will be closely monitored during and after infusion. Vital signs will be monitored every 10 minutes during infusion. In the event of worsening hemodynamics or respiratory status, the infusion will be discontinued. Each subject will be monitored closely and followed up throughout his/her hospitalization. Moreover, he/she will be assessed for safety and efficacy parameters over 60 days from randomization.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A subject will be eligible for inclusion in the study if he/she fulfills the following criteria:

  1. Adult male or female aged 18 years or older
  2. 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).
  3. The first dose of the study drug should be administered within 48 hours of confirming moderate to severe ARDS.
  4. Requires vasopressor support
  5. Written informed consent

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:

  1. Receiving or expected to receive extracorporeal membrane oxygenation or high-frequency oscillatory ventilation
  2. Confirmed pregnancy
  3. Breast feeding
  4. Participating in another interventional study
  5. Requires or having the renal replacement therapy
  6. Hepatic failure (Child-Pugh scores B and C)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal saline
Placebo (Dose: equal volume saline) + Standard of care
Drug: Normal Saline
Placebo (Dose: equal volume saline) + Standard of care
Other Names:
  • Vehicle
Active Comparator: Centhaquine
Centhaquine (Dose: 0.01 mg/kg) + Standard of care
Drug: Centhaquine
Centhaquine (Dose: 0.01 mg/kg) + Standard of care
Other Names:
  • PMZ-2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of PaO2/FiO2 ratio ≥200 mmHg or relative increase by 50 mmHg from baseline
Time Frame: 3 days
The study's primary objective is to determine the clinical effect of centhaquine in patients with moderate to severe ARDS.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day all-cause mortality
Time Frame: 28 days
Incidence of 28-day all-cause mortality
28 days
Ventilator free days (VFDs)
Time Frame: 28 days
Ventilator free days (VFDs) in hospital [Time frame: The number of days beginning with the day of the episode counted as "Day 1 through Day 28, during which the patient is being cared for in the hospital]
28 days
Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 28 days
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
28 days
60-day all-cause mortality
Time Frame: 60 days
Incidence of 60-day all-cause mortality
60 days
Time to clinical improvement on WHO 8-point ordinal scale
Time Frame: 60 days
Time to clinical improvement on WHO 8-point ordinal scale (ranging from 1-Ambulatory to 8-Death)
60 days
Hospital free days
Time Frame: 28 days
Hospital free days [Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28]
28 days
ICU free days
Time Frame: 28 days
• ICU free days [Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28]
28 days
Days alive free of renal replacement therapy
Time Frame: 28 days
• Days alive free of renal replacement therapy [Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28]
28 days
Days alive free of vasopressor(s)
Time Frame: 28 days
Days alive free of vasopressor(s) [Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28]
28 days
A ≥ 50% reduction in vasopressor(s) (norepinephrine equivalents; NEE) dose.
Time Frame: 3 days
The proportion of patients who have a ≥ 50% reduction of vasopressor(s) (norepinephrine equivalent; NEE) dose from the time of randomization [Time frame: 24 hours, 48 hours, 72 hours from the time of randomization].
3 days
Change in blood lactate
Time Frame: 3 days
Change in blood lactate [Time frame: Day 1 through Day 3]
3 days
Change in Sequential Organ Failure Assessment (SOFA) Score
Time Frame: 9 days
• Change in Sequential Organ Failure Assessment (SOFA) score [Time frame: baseline through Day 9 or at the time of hospital discharge, whichever is earlier.]
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmazz, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Centhaquine/ARDS /CT-2.2/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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