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Tyrosine Kinase Inhibitor

Imatinib for COVID-19

Phase 3
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalized patients ≥ 18 years of age
Be older than 18 years old
Must not have
Patients with significant liver or renal dysfunction function at screen as defined as: Direct bilirubin > 2.5 mg/dL, AST, ALT, or alkaline phosphatase > 5 x upper limit of normal, eGFR ≤ 30 mL/min or requiring renal replacement therapy
Patients with significant hematologic disorder at screen as defined as: Absolute neutrophil count (ANC) < 500/μL, Platelet < 20,000/μL, Hemoglobin < 7 g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 and day 60 post baseline
Awards & highlights
Pivotal Trial

Summary

This trial is testing if a drug called imatinib is safe and effective for treating people hospitalized with COVID-19. The trial is randomized, which means that people are assigned by chance to either receive imatinib or a placebo (a medicine with no active ingredient). Neither the participants nor the researchers will know who is receiving imatinib or the placebo until the trial is over.

Who is the study for?
This trial is for hospitalized adults over 18 with a positive COVID-19 test. They must understand and sign consent, or have a representative do so if they're too unwell. Excluded are pregnant/breastfeeding women, those in other drug trials (except certain emergency use treatments), people allergic to Imatinib, and those with severe heart, liver, kidney or blood disorders.
What is being tested?
The study tests the safety and effectiveness of Imatinib compared to a placebo in treating COVID-19 in hospitalized adults. It's randomized (participants are randomly assigned) and double-blind (neither participants nor researchers know who gets what treatment).
What are the potential side effects?
While not specified here, common side effects of Imatinib may include nausea, vomiting, muscle cramps or pain, fatigue, skin rash; there could also be more serious risks like liver problems or severe fluid retention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and currently in the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My liver and kidney functions are within normal limits.
Select...
My blood counts are within a healthy range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 and day 60 post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 and day 60 post baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of patients with a two-point change using the 8-category ordinal scale
Secondary study objectives
All-Cause mortality
Discontinuation due to adverse events
Duration of ECMO or invasive mechanical ventilation
+6 more

Side effects data

From 2022 Phase 3 trial • 330 Patients • NCT03112603
34%
Anaemia
21%
Pyrexia
20%
Hypertension
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Diarrhoea
15%
Fatigue
15%
Pneumonia
15%
Neutropenia
15%
Cough
13%
Thrombocytopenia
12%
Arthralgia
12%
Nausea
12%
Aspartate aminotransferase increased
12%
Upper respiratory tract infection
12%
Gamma-glutamyltransferase increased
12%
Platelet count decreased
12%
Dyspnoea
11%
Back pain
10%
Nasopharyngitis
10%
Influenza
10%
Myalgia
10%
Hypertriglyceridaemia
10%
Headache
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Hyperglycaemia
8%
Oedema peripheral
8%
Conjunctivitis
8%
Constipation
8%
Hypercholesterolaemia
8%
Urinary tract infection
8%
Insomnia
7%
Blood creatine phosphokinase increased
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Amylase increased
7%
Dry eye
6%
Pain in extremity
6%
Leukopenia
6%
Lipase increased
5%
COVID-19
5%
Hyperuricaemia
5%
Hypomagnesaemia
5%
BK virus infection
5%
Fibrin D dimer increased
5%
Cytomegalovirus infection reactivation
5%
Rhinorrhoea
4%
Bronchitis
4%
Abdominal pain
4%
Tremor
3%
Lower respiratory tract infection
2%
Dyspepsia
2%
Pneumonia bacterial
2%
Sepsis
2%
Bronchopulmonary aspergillosis
2%
Herpes zoster
2%
Asthenia
2%
Osteonecrosis
2%
Hypophosphataemia
2%
COVID-19 pneumonia
2%
Pneumothorax
2%
Pulmonary embolism
2%
Cataract
2%
Febrile neutropenia
1%
Respiratory failure
1%
Anal abscess
1%
Anastomotic complication
1%
Pneumococcal infection
1%
Tracheitis
1%
Haemorrhage intracranial
1%
Bacteraemia
1%
Pancreatitis acute
1%
Meningitis viral
1%
Muscular weakness
1%
Epilepsy
1%
Oral candidiasis
1%
Pseudomonal sepsis
1%
Respiratory syncytial virus infection
1%
Catheter site haemorrhage
1%
Bacterial translocation
1%
Respiratory tract infection
1%
Deep vein thrombosis
1%
Tendon disorder
1%
Tachypnoea
1%
Decreased appetite
1%
Cytomegalovirus infection
1%
Enterococcal infection
1%
Lower respiratory tract infection fungal
1%
Adenovirus reactivation
1%
Systemic infection
1%
Fungal infection
1%
Pneumonia cytomegaloviral
1%
Respiratory tract infection viral
1%
Basal cell carcinoma
1%
Spinal cord compression
1%
Cytomegalovirus test positive
1%
Meningitis cryptococcal
1%
Mycobacterial infection
1%
Infusion related reaction
1%
Syncope
1%
Septic shock
1%
White blood cell count decreased
1%
Measles
1%
Dehydration
1%
Vulvovaginal inflammation
1%
Squamous cell carcinoma of skin
1%
Stomatitis
1%
Respiratory tract infection fungal
1%
Depressed level of consciousness
1%
Escherichia sepsis
1%
Loss of personal independence in daily activities
1%
Spinal compression fracture
1%
Acute respiratory distress syndrome
1%
Erysipelas
1%
Pneumocystis jirovecii pneumonia
1%
General physical health deterioration
1%
Post transplant lymphoproliferative disorder
1%
Hypotension
1%
Generalised oedema
1%
Multiple organ dysfunction syndrome
1%
Brain abscess
1%
Acute kidney injury
1%
Renal impairment
1%
Alveolar proteinosis
1%
Hypoxia
1%
Organising pneumonia
1%
Pleuritic pain
1%
Pneumonitis
1%
Pulmonary oedema
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Pruritus
1%
Gastrointestinal ulcer
1%
Atrial flutter
1%
Cardiac failure congestive
1%
Haematemesis
1%
Melaena
1%
Splenic haemorrhage
1%
Corneal erosion
1%
Corneal perforation
1%
Angle closure glaucoma
1%
Ileus
1%
Pyelonephritis
1%
Respiratory tract infection bacterial
1%
SARS-CoV-2 test positive
1%
Skin squamous cell carcinoma recurrent
1%
Squamous cell carcinoma
1%
Completed suicide
1%
Confusional state
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ImatinibExperimental Treatment1 Intervention
Imatinib oral 400 mg daily for 14 days.
Group II: PlaceboActive Control1 Intervention
Placebo oral for 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,288 Total Patients Enrolled

Media Library

Imatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04394416 — Phase 3
Coronavirus Research Study Groups: Imatinib, Placebo
Coronavirus Clinical Trial 2023: Imatinib Highlights & Side Effects. Trial Name: NCT04394416 — Phase 3
Imatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04394416 — Phase 3
~38 spots leftby Nov 2025
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