Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B342- Coronavirus infection, unspecified
Conditions
Interventions
Intervention1: Imatinib 8 mg/mL: 25 mL of study drug administered as an IV infusion over two hours (12.5mL/hour)twice daily for 10 days.
Control Intervention1: Placebo: 25 mL of study drug administere
Sponsors
Exvastat Limited
Exvastat Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients aged ââ?°Â¥18 years; Women of childbearing potential must have a negative serum pregnancy test to confirm eligibility, Provision of signed written informed consent from the patient or patientââ?¬•s legally acceptable representative, SARS-CoV-2 infection confirmed by RT-PCR laboratory test (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19), Meet Berlin definition for moderate ââ?¬â?? severe ARDS: ââ?¬Â¢Bilateral opacities ââ?¬â? not fully explained by effusions, lobar/lung collapse, or nodules ââ?¬Â¢Respiratory failure not fully explained by cardiac failure or fluid overload. ââ?¬Â¢PaO2/FIO2 ââ?°Â¤200 mmHg with PEEP ââ?°Â¥5 cmH2O; Patient requires intubation or is currently intubated and has been for ââ?°Â¤48 hours.
Exclusion criteria
Exclusion criteria: Persistent septic shock ( >24 hours) with a Mean Arterial Pressure (MAP) â�¤65 mm Hg and serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation and vasopressor use (norepinephrine >0.2 �¼g/kg/min) for >6 hours, major trauma in the past 5 days, Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year,Pre-existing severe cardiopulmonary disease including, but not limited to, interstitial lung disease; severe COPD (GOLD Stage IV or FEV1 12 (Appendix 1),White blood count 10x upper limit of normal (ULN) or bilirubin >3x ULN, Women who are pregnant or breast-feeding; Use of drugs with strong CYP3A4 induction potential, such as carbamazepine, efavirenz, enzalutamide, phenobarbital, phenytoin, hypericum, mitotane, nevirapine, primidone, rifabutin and rifampicin;Inability of the ICU staff to initiate administration of study treatment within 48 hours of intubation; Enrolled in a concomitant clinical trial of an investigational medicinal product, In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of IV imatinib compared to placebo in reducing ARDS severity in patients with critical COVID-19 receiving standard of care.Timepoint: Change (from baseline) in Oxygen Saturation Index (OSI) at Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate if IV imatinib compared to placebo has an early effect on ARDS severity in patients with critical COVID-19 receiving standard of care. To evaluate the effect of IV imatinib compared to placebo on clinical outcomes in patients with critical COVID-19 receiving standard of care.Timepoint: Change(from baseline)in OSI at Day3 and Day5,Mortality rate at Day29 and Day60.Change(from baseline) in WHO9-point ordinal Scale for Clinical Improvement to Day10 and Day29 (All/Survivors),Duration of mechanical ventilation (days)to Day29 and Day60 (All/Survivors),Duration of stay in ICU/hospital(days) to Day29 and Day60(All/Survivors),Time to first successful extubation (hours):From randomization to Day29,Number of days free of mechanical ventilation and survival (VFDsurv)at Day29 and Day60 | — |
Countries
India
Contacts
Public ContactDr Ramesh K S
Syngene International Ltd
Outcome results
None listed