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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 and day 60 post baseline
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
I am 18 or older and currently in the hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28 and day 60 post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 and day 60 post baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of patients with a two-point change using the 8-category ordinal scale
Secondary outcome measures
All-Cause mortality
Discontinuation due to adverse events
Duration of ECMO or invasive mechanical ventilation
+6 moreSide effects data
From 2022 Phase 3 trial • 330 Patients • NCT0311260334%
Anaemia
21%
Pyrexia
20%
Hypertension
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Diarrhoea
15%
Pneumonia
15%
Neutropenia
15%
Fatigue
15%
Cough
13%
Thrombocytopenia
12%
Nausea
12%
Gamma-glutamyltransferase increased
12%
Aspartate aminotransferase increased
12%
Platelet count decreased
12%
Arthralgia
12%
Dyspnoea
12%
Upper respiratory tract infection
11%
Back pain
10%
Influenza
10%
Headache
10%
Nasopharyngitis
10%
Hypertriglyceridaemia
10%
Myalgia
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Constipation
8%
Oedema peripheral
8%
Hypercholesterolaemia
8%
Conjunctivitis
8%
Insomnia
8%
Urinary tract infection
8%
Hyperglycaemia
7%
Dry eye
7%
Amylase increased
7%
Blood alkaline phosphatase increased
7%
Blood creatine phosphokinase increased
7%
Hyperkalaemia
6%
Leukopenia
6%
Lipase increased
6%
Pain in extremity
5%
COVID-19
5%
BK virus infection
5%
Fibrin D dimer increased
5%
Rhinorrhoea
5%
Hyperuricaemia
5%
Cytomegalovirus infection reactivation
5%
Hypomagnesaemia
4%
Bronchitis
4%
Tremor
4%
Abdominal pain
3%
Lower respiratory tract infection
2%
Sepsis
2%
Febrile neutropenia
2%
Bronchopulmonary aspergillosis
2%
COVID-19 pneumonia
2%
Herpes zoster
2%
Pneumonia bacterial
2%
Osteonecrosis
2%
Dyspepsia
2%
Cataract
2%
Pulmonary embolism
2%
Pneumothorax
2%
Asthenia
2%
Hypophosphataemia
1%
Generalised oedema
1%
Pancreatitis acute
1%
Oral candidiasis
1%
Mycobacterial infection
1%
Pseudomonal sepsis
1%
Respiratory tract infection fungal
1%
Gastrointestinal ulcer
1%
Ileus
1%
Atrial flutter
1%
Completed suicide
1%
Pulmonary oedema
1%
Hypotension
1%
Splenic haemorrhage
1%
Cardiac failure congestive
1%
Haematemesis
1%
Stomatitis
1%
Catheter site haemorrhage
1%
Angle closure glaucoma
1%
Bacterial translocation
1%
Melaena
1%
Meningitis cryptococcal
1%
General physical health deterioration
1%
Fungal infection
1%
Multiple organ dysfunction syndrome
1%
Squamous cell carcinoma
1%
Confusional state
1%
Brain abscess
1%
Cytomegalovirus infection
1%
Bacteraemia
1%
Systemic infection
1%
Enterococcal infection
1%
Erysipelas
1%
Meningitis viral
1%
Escherichia sepsis
1%
Pyelonephritis
1%
Pneumocystis jirovecii pneumonia
1%
Spinal compression fracture
1%
Respiratory tract infection viral
1%
Pneumonia cytomegaloviral
1%
Septic shock
1%
Lower respiratory tract infection fungal
1%
Respiratory tract infection
1%
Measles
1%
Pneumococcal infection
1%
Infusion related reaction
1%
Cytomegalovirus test positive
1%
Respiratory syncytial virus infection
1%
Respiratory tract infection bacterial
1%
Renal impairment
1%
Tracheitis
1%
Depressed level of consciousness
1%
SARS-CoV-2 test positive
1%
Anastomotic complication
1%
Decreased appetite
1%
Acute kidney injury
1%
Pleuritic pain
1%
Squamous cell carcinoma of skin
1%
White blood cell count decreased
1%
Syncope
1%
Dehydration
1%
Tendon disorder
1%
Skin squamous cell carcinoma recurrent
1%
Organising pneumonia
1%
Epilepsy
1%
Basal cell carcinoma
1%
Alveolar proteinosis
1%
Vulvovaginal inflammation
1%
Hypoxia
1%
Pneumonitis
1%
Post transplant lymphoproliferative disorder
1%
Spinal cord compression
1%
Acute respiratory distress syndrome
1%
Haemorrhage intracranial
1%
Tachypnoea
1%
Deep vein thrombosis
1%
Loss of personal independence in daily activities
1%
Respiratory failure
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Pruritus
1%
Anal abscess
1%
Corneal erosion
1%
Corneal perforation
1%
Adenovirus reactivation
1%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period
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
688 Previous Clinical Trials
374,452 Total Patients Enrolled
4 Trials studying COVID-19
117 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver and kidney functions are within normal limits.I am 18 or older and currently in the hospital.My blood counts are within a healthy range.You are not taking part in any other experimental drug studies. It's okay if you are using certain medications that are not officially approved for your condition, as long as they are considered standard care or have emergency approval. This includes antivirals like remdesivir that have been authorized by the FDA for emergency use.You tested positive for COVID-19 in a respiratory tract sample within the last 7 days.I can understand and am willing to sign the consent form, or my legal representative can do it if I'm too unwell.I do not have any severe illnesses that my doctor thinks would interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Imatinib
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary conditions that Imatinib is meant to treat?
"Acute lymphoblastic leukemia is often treated with Imatinib. However, this medication can also help patients with refractory acute lymphoblastic leukemia (all), muscular dystrophy, and metastatic dermatofibrosarcoma protuberans."
Answered by AI
Has Imatinib been federally sanctioned in the United States?
"Imatinib has received a 3 for safety from our team at Power. A Phase 3 trial means that, not only is there some evidence for the medication's efficacy, but there are also multiple rounds of data affirming its safety."
Answered by AI
How many enrollees does this research project have at full capacity?
"Yes, the most recent update on clinicaltrials.gov suggests that this study is still looking for patients. The trial was initially posted on June 2nd, 2020 and was updated on July 19th, 2020. A total of 204 individuals are needed for the study, which is taking place at a single site."
Answered by AI
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