Trial Outcomes & Findings for Trial of Imatinib for Hospitalized Adults With COVID-19 (NCT NCT04394416)
NCT ID: NCT04394416
Last Updated: 2026-03-25
Results Overview
The primary endpoint is all-cause mortality at Day 28 after the start of imatinib/placebo.
TERMINATED
PHASE3
21 participants
Day 28 after the start of imatinib/placebo.
2026-03-25
Participant Flow
Participant milestones
| Measure |
Imatinib
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Imatinib
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
2
|
2
|
Baseline Characteristics
Trial of Imatinib for Hospitalized Adults With COVID-19
Baseline characteristics by cohort
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=138 Participants
|
5 Participants
n=62 Participants
|
9 Participants
n=123 Participants
|
|
Age, Continuous
|
63 years
n=138 Participants
|
61 years
n=62 Participants
|
61 years
n=123 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
9 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=138 Participants
|
5 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=138 Participants
|
11 participants
n=62 Participants
|
21 participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Day 28 after the start of imatinib/placebo.The primary endpoint is all-cause mortality at Day 28 after the start of imatinib/placebo.
Outcome measures
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
To Evaluate the Efficacy and Safety of Oral Administration of Imatinib Combined With BCC vs. Placebo Plus BCC in Hospitalized Patients With COVID-19
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 29 to Day 60 after the start of imatinib/placeboAll-cause mortality post baseline
Outcome measures
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
All-Cause Mortality
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14 from baselinePopulation: No participants were measured/analyzed and no data are available for analysis for this outcome measure. The planned ordinal scale required for assessment of this outcome measure was omitted and the PI did not complete the assessment nor collect information before study termination. The study was terminated early prior to implementation of this endpoint. Due to the pending termination/IRB closure, the protocol was not updated to remove this measure to reduce administrative burden.
The proportion of participants with two-point improvement at Day 14 from baseline using the 8-category ordinal scale. The ordinal scale is an evaluation of the status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 days post baselineDuration of hospitalization
Outcome measures
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Hospitalization
|
19.3 days
Standard Deviation 9.15
|
17.3 days
Standard Deviation 12.91
|
SECONDARY outcome
Timeframe: Up to 60 days post baselinePopulation: A total of 10 participants were on ventilation or ECMO on Day 1. Of the 10 participants, 5 were taken off ventilation or ECMO and 5 were not. Therefore, only 3 participants in Arm 1 and 2 participants in Arm 2 were able to contribute days data to calculate the mean and SD.
For subjects who are on ECMO or mechanical ventilation at Day 1
Outcome measures
| Measure |
Imatinib
n=3 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=2 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Duration of ECMO or Invasive Mechanical Ventilation
|
17.3 days
Standard Deviation 8.62
|
10.5 days
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: Up to 60 days post baselineFor subjects who are in ICU at Day 1
Outcome measures
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Duration of ICU Stay
|
14 days
Standard Deviation 5.26
|
9.26 days
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: Day 14Population: No participants were measured or analyzed for this outcome measure. The study was terminated early, prior to collection of this endpoint. In addition, a case report form was not developed to capture the proportion of patients with a negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by quantitative RT-PCR on Days 14 and 28. As a result, these data were not collected, and no data are available for analysis for this outcome measure.
Proportion of patients with a negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by quantitative RT PCR on days 14 and 28
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 28Population: No participants were measured or analyzed for this outcome measure. The study was terminated early, prior to collection of this endpoint. In addition, a case report form was not developed to capture the proportion of patients with a negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by quantitative RT-PCR on Days 14 and 28. As a result, these data were not collected, and no data are available for analysis for this outcome measure.
Proportion of patients with a negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by quantitative RT PCR on days 14 and 28
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 days post baselinePercentage of subjects with serious adverse events
Outcome measures
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Serious Adverse Events (SAEs)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 60 days post baselinePercentage of subjects who discontinue study drug due to adverse events
Outcome measures
| Measure |
Imatinib
n=10 Participants
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 Participants
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Discontinuation Due to Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 60 days post baselinePopulation: No participants were measured/analyzed and no data are available for analysis for this outcome measure. The planned form required for assessment of this outcome measure was omitted/not created and the PI did not complete the assessment nor collect information before study termination. The study was terminated early prior to implementation of this endpoint. Due to the pending termination/IRB closure, the protocol was not updated to remove this measure to reduce administrative burden.
Time to a 2-point clinical improvement difference over baseline
Outcome measures
Outcome data not reported
Adverse Events
Imatinib
Placebo
Serious adverse events
| Measure |
Imatinib
n=10 participants at risk
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 participants at risk
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Nervous system disorders
Intracranial hemorrhage
|
10.0%
1/10 • Number of events 2 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/10 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Gastrointestinal disorders
Organ Failure
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • 1 year, 3 months
|
9.1%
1/11 • Number of events 2 • 1 year, 3 months
|
Other adverse events
| Measure |
Imatinib
n=10 participants at risk
Imatinib oral 400 mg daily for 14 days.
Imatinib: Therapeutic
|
Placebo
n=11 participants at risk
Placebo oral for 14 days
Placebo oral tablet: Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
8/10 • Number of events 20 • 1 year, 3 months
|
54.5%
6/11 • Number of events 18 • 1 year, 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia / Thrombocytosis
|
60.0%
6/10 • Number of events 10 • 1 year, 3 months
|
27.3%
3/11 • Number of events 4 • 1 year, 3 months
|
|
Blood and lymphatic system disorders
Coagulopathy / ↑PT/PTT/INR / low fibrinogen
|
30.0%
3/10 • Number of events 5 • 1 year, 3 months
|
9.1%
1/11 • Number of events 3 • 1 year, 3 months
|
|
Blood and lymphatic system disorders
Leukocytosis / Leukopenia / Neutropenia
|
30.0%
3/10 • Number of events 5 • 1 year, 3 months
|
27.3%
3/11 • Number of events 4 • 1 year, 3 months
|
|
Cardiac disorders
Atrial fibrillation / flutter
|
40.0%
4/10 • Number of events 6 • 1 year, 3 months
|
18.2%
2/11 • Number of events 2 • 1 year, 3 months
|
|
Cardiac disorders
Sinus tachycardia
|
30.0%
3/10 • Number of events 4 • 1 year, 3 months
|
18.2%
2/11 • Number of events 2 • 1 year, 3 months
|
|
Cardiac disorders
Cardiac and respiratory arrest
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Gastrointestinal disorders
Abdominal pain / suprapubic
|
30.0%
3/10 • Number of events 3 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 3 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 5 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Gastrointestinal disorders
Gastrointestinal bleeding / melena
|
20.0%
2/10 • Number of events 2 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
2/10 • Number of events 2 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Hepatobiliary disorders
Elevated ALT / AST / Alkaline Phosphatase
|
0.00%
0/10 • 1 year, 3 months
|
45.5%
5/11 • Number of events 11 • 1 year, 3 months
|
|
Hepatobiliary disorders
Chronic Acalculous Cholecystitis
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Renal and urinary disorders
Acute kidney injury / Acute on chronic
|
40.0%
4/10 • Number of events 5 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/10 • 1 year, 3 months
|
18.2%
2/11 • Number of events 2 • 1 year, 3 months
|
|
Renal and urinary disorders
Urinary tract infection / cystitis / bacteriuria
|
30.0%
3/10 • Number of events 4 • 1 year, 3 months
|
18.2%
2/11 • Number of events 3 • 1 year, 3 months
|
|
Renal and urinary disorders
Urinary frequency / urgency / retention
|
30.0%
3/10 • Number of events 3 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Nervous system disorders
Altered mental status / encephalopathy / confusion
|
30.0%
3/10 • Number of events 3 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Nervous system disorders
Resting tremor
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Eye disorders
Blurred vision / vision changes
|
20.0%
2/10 • Number of events 2 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
General disorders
Edema (generalized / facial / BLE / bilateral lower extremities / forehead / Bipedal)
|
60.0%
6/10 • Number of events 10 • 1 year, 3 months
|
54.5%
6/11 • Number of events 13 • 1 year, 3 months
|
|
General disorders
Fever / CRS (Fever / Hypotension / Tachycardia)
|
60.0%
6/10 • Number of events 12 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
General disorders
Shock (distributive / undifferentiated / hemorrhagic / metabolic / respiratory)
|
30.0%
3/10 • Number of events 4 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea / Shortness of breath / Orthopnea / PND / ARDS / Hypoxic Respiratory Failure / Refractory Hy
|
40.0%
4/10 • Number of events 5 • 1 year, 3 months
|
45.5%
5/11 • Number of events 7 • 1 year, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough / Productive cough / Mucus plugging
|
30.0%
3/10 • Number of events 4 • 1 year, 3 months
|
18.2%
2/11 • Number of events 2 • 1 year, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax / Pleural effusions
|
20.0%
2/10 • Number of events 2 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Skin and subcutaneous tissue disorders
Rash / Skin lesion / Ecchimosis
|
30.0%
3/10 • Number of events 3 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain / Sacrum pain / Joint pain / Myalgia / Pain at amputation site
|
40.0%
4/10 • Number of events 5 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Infections and infestations
Bacteremia (incl. Enterococcus, Staph)
|
20.0%
2/10 • Number of events 3 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Infections and infestations
E. Coli UTI
|
0.00%
0/10 • 1 year, 3 months
|
18.2%
2/11 • Number of events 2 • 1 year, 3 months
|
|
Infections and infestations
Herpes virus simplex
|
0.00%
0/10 • 1 year, 3 months
|
9.1%
1/11 • Number of events 1 • 1 year, 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia / Steroid-induced hyperglycemia
|
30.0%
3/10 • Number of events 4 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Injury, poisoning and procedural complications
Intubation
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Injury, poisoning and procedural complications
Acute hemorrhage
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
General disorders
Multi-organ failure
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
General disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • 1 year, 3 months
|
0.00%
0/11 • 1 year, 3 months
|
|
Vascular disorders
Deep vein thrombosis / Non-occlusive DVT
|
0.00%
0/10 • 1 year, 3 months
|
9.1%
1/11 • Number of events 2 • 1 year, 3 months
|
Additional Information
Andrea Levine, MD
University of Maryland Greenebaum Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place