A Phase 2 interventional study of Imatinib Mesylate and Placebo in Acute Respiratory Distress Syndrome, COVID-19 Acute Respiratory Distress Syndrome and Covid19, sponsored by Exvastat Ltd.. Withdrawn at 8 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by Exvastat Ltd. · Phase 2, Interventional, and Treatment
Among 15 studies in Respiratory Distress Syndrome with a site in India — 2 open to participants now, 3 under way, 1 of them phase 3. Respiratory Distress Syndrome · India.
Among the 15 studies in Respiratory Distress Syndrome with a site in India, this one is the only one that started in 2021, is one of 2 in phase 2, and was the 12th registered.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
Browse Respiratory Distress Syndrome studies →2 of the 15 studies in Respiratory Distress Syndrome with a site in India are open now. Recruiting first, the newest first:
TS Misra Medical College · Sites in India
Ages 18+
AstraZeneca · Sites in India, United States, Argentina and 36 more countries
Ages 18+
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 194 Respiratory Distress Syndrome studies recruiting now, 118 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 51 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 3
First in 2009; this study’s year is marked. 1 started in 2021.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 78 across the 8 interventional studies, 120 across the 7 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 15 have an industry lead sponsor. The 10 most frequent:
Exvastat Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Exvastat Ltd. has 1 study filed under Respiratory Distress Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Respiratory Distress Syndrome with a site in India that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07269743TS Misra Medical CollegeAEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS) | 2026-12-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 15 studies in Respiratory Distress Syndrome with a site in India, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The COVID-19 pandemic has led to an increase in the number of patients admitted to intensive care units (ICU) with acute respiratory distress syndrome (ARDS). ARDS is a severe, life-threatening medical condition characterised by inflammation and fluid in the lungs. There is no proven therapy to reduce fluid leak, also known as pulmonary oedema, in ARDS. However, recent studies have discovered that imatinib prevents fluid leak in the lungs in inflammatory conditions, while leaving the immune response intact.
Adding imatinib into the standard care package may, therefore, decrease mortality and reduce the duration of mechanical ventilation compared with standard care alone, in critically-ill patients with COVID-19.
To help determine the impact of imatinib in these patients we present a randomised, double-blind, multi-centre, 2-arm, parallel-group, placebo-controlled clinical study of intravenous imatinib in 84 mechanically-ventilated, adult subjects with COVID-19-related ARDS.
Study participants (patients who have consented into the study) will receive the study drug (imatinib or placebo) twice daily for a period of 10 days. The effect of the intervention will be tested by measuring the change from baseline in the Oxygen Saturation Index (OSI) at day 10. OSI is a non-invasive means of measuring oxygenation and is an independent predictor of mortality in patients with ARDS, serving thus as a relevant endpoint from which to assess the efficacy of imatinib.
Other measurements will include regular blood tests as part of safety assessments.
Time on ventilation and morbidity and mortality will be recorded as secondary outcome measures.
Blood tests will also allow the investigation of the pharmacokinetic properties of imatinib, as well as biomarkers of inflammation.
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.
Meet Berlin definition for moderate - severe ARDS
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous Imatinib Mesylate solution- 200mg as an 8mg/ml solution, administered twice daily (400mg total daily dose). Each dose administered in a 25ml solution over a two-hour infusion period.
Drug: Imatinib Mesylate
Intravenous Placebo matched solution- administered 25ml solution, twice daily over a two-hour infusion period
Drug: Placebo
An isotonic sterile solution of imatinib.
Also known as: Impentri
An isotonic sterile solution
Change from baseline in Oxygen Saturation Index (OSI) at Day 10
Oxygen saturation is a calculation derived from \[mean airway pressure × FiO2 × 100\] / SpO2.
Time frame: From Baseline to Day 10
Change from Baseline in Oxygen Saturation Index (OSI) at Day 3 and Day 5
Oxygen saturation measured by pulse oximetry
Time frame: From Baseline to Day 3 and from baseline to Day 5
Mortality rate at Day 29 and Day 60
Mortality at Day 29 and Day 60
Time frame: Day 29 and Day 60
Change from baseline in WHO 9-point ordinal scale for clinical improvement to Day 10 and Day 29
The WHO Ordinal Scale for Clinical Improvement (0 to 8, where a higher value indicates worse outcome). It measures illness severity over time using the following categories: Uninfected, Ambulatory (no limitation of activities), Ambulatory (limitation of activities), Hospitalized (no O2 therapy), Hospitalized (O2 by nasal prongs or mask), Hospitalized (O2 by NIV or HFNO), Hospitalized (intubation and invasive mechanical ventilation), Hospitalized (ventilation and additional organ support \[vasopressors, CVVH, ECMO\]), Death.
Time frame: The WHO ordinal scale will be recorded Days 1-10 and Day 29
Duration of mechanical ventilation (Days) to Day 29 and Day 60
Number of days requiring to be on mechanical ventilation
Time frame: To Day 29 and to Day 60
Duration of stay in ICU (Days) to Day 29 and Day 60
Number of days within the ICU
Time frame: To Day 29 and to Day 60
Time to first successful extubation (Hours) to Day 29
Number of hours to extubation (removal of the endotracheal tube)
Time frame: To Day 29
Number of days free of mechanical ventilation and survival (VFDsurv) at Day 29 and Day 60
Amongst survivors, the number of days free from mechanical ventilation
Time frame: At Day 29 and Day 60
Safety- Type, frequency, severity, and relationship to study treatment of any AEs, SAEs or AEs leading to discontinuation of study treatment from Day 1 to Day 29 (final follow up visit)
Safety adverse events and serious adverse event collection
Time frame: Day 1 to Day 29
Incidence of related Treatment-Emergent Adverse Events- Tolerability
Tolerability
Time frame: Day 1 to Day 29
Pharmacokinetic- Imatinib plasma concentration
Imatinib plasma concentration- Multivariate hierarchical analysis will be performed on various factors (age, sex, weight, height,appha-1-acid glycoprotein, haemoglobin, ALAT, CRP, eGFR, albumin, smoking, and concomitant drugs) to explore sources of variability in patient outcome. Significant predictors will be used as covariates to improve the performance of the PK model.
Time frame: 4 samples collected Day 1, and single samples collected Days 3 and 5
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2021; primary completion for Aug 2022, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imatinib
Respiratory Distress Syndrome →
Exvastat Ltd.