A Phase 2 interventional study of Normal Saline and Centhaquine in Acute Respiratory Distress Syndrome (ARDS), sponsored by Pharmazz, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pharmazz, Inc. · Phase 2, Interventional, and Treatment
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.
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):
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Pharmazz, Inc. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A subject will be eligible for inclusion in the study if he/she fulfills the following criteria:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo (Dose: equal volume saline) + Standard of care
Drug: Normal Saline
Centhaquine (Dose: 0.01 mg/kg) + Standard of care
Drug: Centhaquine
Placebo (Dose: equal volume saline) + Standard of care
Also known as: Vehicle
Centhaquine (Dose: 0.01 mg/kg) + Standard of care
Also known as: PMZ-2010
Improvement of PaO2/FiO2 ratio ≥200 mmHg or relative increase by 50 mmHg from baseline
The study's primary objective is to determine the clinical effect of centhaquine in patients with moderate to severe ARDS.
Time frame: 3 days
28-day all-cause mortality
Incidence of 28-day all-cause mortality
Time frame: 28 days
60-day all-cause mortality
Incidence of 60-day all-cause mortality
Time frame: 60 days
Time to clinical improvement on WHO 8-point ordinal scale
Time to clinical improvement on WHO 8-point ordinal scale (ranging from 1-Ambulatory to 8-Death)
Time frame: 60 days
Hospital free days
Hospital free days \[Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28\]
Time frame: 28 days
ICU free days
• ICU free days \[Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28\]
Time frame: 28 days
Ventilator free days (VFDs)
Ventilator free days (VFDs) in hospital \[Time frame: The number of days beginning with the day of the episode counted as "Day 1 through Day 28, during which the patient is being cared for in the hospital\]
Time frame: 28 days
Days alive free of renal replacement therapy
• Days alive free of renal replacement therapy \[Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28\]
Time frame: 28 days
Days alive free of vasopressor(s)
Days alive free of vasopressor(s) \[Time frame: The number of days beginning with the day of randomization counted as "Day 1" through Day 28\]
Time frame: 28 days
A ≥ 50% reduction in vasopressor(s) (norepinephrine equivalents; NEE) dose.
The proportion of patients who have a ≥ 50% reduction of vasopressor(s) (norepinephrine equivalent; NEE) dose from the time of randomization \[Time frame: 24 hours, 48 hours, 72 hours from the time of randomization\].
Time frame: 3 days
Change in blood lactate
Change in blood lactate \[Time frame: Day 1 through Day 3\]
Time frame: 3 days
Change in Sequential Organ Failure Assessment (SOFA) Score
• Change in Sequential Organ Failure Assessment (SOFA) score \[Time frame: baseline through Day 9 or at the time of hospital discharge, whichever is earlier.\]
Time frame: 9 days
Adverse events (AEs) and serious adverse events (SAEs)
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame: 28 days
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Centhaquine
Respiratory Distress Syndrome →
Pharmazz, Inc.