COVID-19Phase 3NCT04422678
The Safety & Efficacy of Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia
A Phase 3 study testing Imatinib Mesylate in people with COVID-19, run by Alexandria University.
Trial summary
A randomized controlled pilot study on the safety \& efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Imatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PCR positive for SARS-COV-2
- Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines
- Informed consent explained \& signed by patient or his 1st degree relatives or legally authorized representative.
Who cannot join
- Pregnant women (or) breast feeding women
- Patients younger than 18 years of age
- Patients with known allergy to imatinib
- Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN).
- Creatinine clearance (CrCl) < 30 mL/minute.
- Patient already on mechanical ventilation at time of screening.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study
A randomized controlled pilot study on the safety \& efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.
Read the detailed description
As the coronavirus disease (COVID-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. A highly elevated levels of cytokines in COVID-19 patients requiring ICU admission, has suggested that a "cytokine storm" was associated with disease severity. Data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. This data is especially derived from imatinib, the most studied Abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. Based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with SARS-CoV-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.
- Conditions
- COVID-19
- Being tested
- Imatinib Mesylate, Standard of Care
- Keywords
- SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm
- Medical subject headings
- COVID-19, Pneumonia, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Also called Imatinib
Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
Standard of CareDrug
Also called Standard
Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Standard Dose | Experimental | Imatinib 400 mg oral tablet once daily for 21 days
In addition for the treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). Receives: Drug: Imatinib Mesylate |
| Imatinib Low Dose | Experimental | Imatinib 200 mg oral tablet once daily for 21 days.
In addition to the treatment for COVID-19 Pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). Receives: Drug: Imatinib Mesylate |
| Control | Active comparator | Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Disease Progression
Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
Measured: 30 Days
Secondary outcomes (7)
Improvement in Hypoxic Index
Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
Measured: From inclusion to 30 days follow up
Hospital Length of Stay
Hospital Length of stay
Measured: From inclusion to 30 days follow up
Days on invasive mechanical ventilation
Days on mechanical ventilation for patients needing intubation \& invasive mechanical ventilation
Measured: From inclusion to 30 days follow up
Inflammatory Markers
Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
Measured: From inclusion to 30 days
Viral clearance
Rate of viral clearance as monitored by SARS-COV-2 PCR
Measured: From inclusion to 30 days
Radiological assessment
Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
Measured: From inclusion to 30 days
Safety of Imatinib
Rate of serious adverse events (SAEs)
Measured: From inclusion to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Responsible party
- Sponsor
- Investigators
- Hany ASSAAD, MD, PhD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422678
- Sponsor's protocol ID
- Alex CCM 2020/5
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study
- ClinicalTrials.gov ID
- NCT04422678
- Acronym / sponsor ID
- Alex CCM 2020/5
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Pneumonia, ARDS, Cytokine Storm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled pilot study on the safety \& efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.
Detailed description
As the coronavirus disease (COVID-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. A highly elevated levels of cytokines in COVID-19 patients requiring ICU admission, has suggested that a "cytokine storm" was associated with disease severity. Data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. This data is especially derived from imatinib, the most studied Abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. Based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with SARS-CoV-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imatinib Standard Dose | Experimental | Drug: Imatinib MesylateImatinib 400 mg oral tablet once daily for 21 days In addition for the treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). |
| Imatinib Low Dose | Experimental | Drug: Imatinib MesylateImatinib 200 mg oral tablet once daily for 21 days. In addition to the treatment for COVID-19 Pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). |
| Control | Active comparator | Drug: Standard of CareTreatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with PCR positive for SARS-COV-2
- Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines
- Informed consent explained \& signed by patient or his 1st degree relatives or legally authorized representative.
Key exclusion criteria (6 listed)
- Pregnant women (or) breast feeding women
- Patients younger than 18 years of age
- Patients with known allergy to imatinib
- Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN).
- Creatinine clearance (CrCl) < 30 mL/minute.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib MesylateAlso: ImatinibAdding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia. | Drug | Imatinib Low Dose, Imatinib Standard Dose |
| Standard of CareAlso: StandardStandard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health. | Drug | Control |
Primary outcome
Primary endpoint: Disease Progression
Time frame: 30 Days
Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
7 secondary outcomes
Improvement in Hypoxic Index
Time frame: From inclusion to 30 days follow up
Hospital Length of Stay
Time frame: From inclusion to 30 days follow up
Days on invasive mechanical ventilation
Time frame: From inclusion to 30 days follow up
Inflammatory Markers
Time frame: From inclusion to 30 days
Viral clearance
Time frame: From inclusion to 30 days
Radiological assessment
Time frame: From inclusion to 30 days
Safety of Imatinib
Time frame: From inclusion to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hany ASSAAD, MD, PhD principal investigator
University of Alexandria
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib Mesylate in people with COVID-19, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASSAAD, MD, PhD (00201223125575, samir.assaadkhalil@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: Disease Progression (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.