COVID-19 PneumoniaPhase 2Covid19COVINIBNCT04346147
Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19
A Phase 2 study testing Imatinib tablets, Baricitinib Oral Tablet and Supportive tratment in people with COVID-19 Pneumonia, run by Hospital Universitario de Fuenlabrada at 1 site in Spain.
Trial summary
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak. For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Imatinib tablets, Baricitinib Oral Tablet and Supportive tratment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSpain
- Study dates
- 7 May 2020to Sep 2021
- Phase
- Phase 2
- 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
- Signed informed consent form
- ≥18 years
- Confirmed diagnosis Pneumonia Covid19 + (Pneumonia confirmed radiologically and positive test for detection of SARS-CoV-2 RNA in respiratory samples)
- ECOG functional state 0 or 1
- Less than 10 days from onset of symptoms saw.
- NO contraindication for medication
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- ECG QT < < 440 ms males and < 460 ms females
- Adequate liver, kidney and hematological function (or within the safety range to use these drugs):
- Absolute granulocyte count> 1.5 x 109 / L
- Absolute platelet count> 100 x 109 / L
- Hb> 10 g / dL
- Cr <1.5 mg / dL or Clearance> 50mL / min
- Bilirubin <3 ULN
- AST / ALT ≤ 2.5 times ULN
Who cannot join
- No Covid confirmation
- No pneumonia
- Previous treatment with any of the study drugs
- Concomitant serious medical condition:
- Congestive Heart failure
- Acute myocardial infarction 6 months prior
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- Unstable Angina
- Cardiomyopathy
- Unstable Ventricular Arrhythmia
- Uncontrolled Hypertension
- Uncontrolled psychotic disorders
- Serious active infections
- HIV infections
- Active hepatitis
- Neoplasia in active cancer treatment
- Inability to take oral medication or malabsorption syndrome saw.
- Inability to comply with study and follow-up procedures
- History of only relevant thromboembolic or hemorrhagic episodes in the last 6 months
- Contraindication to any study medication
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Phase II, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Baricitinib, Imatinib or Supportive Treatment in Patients With SARS Cov2 Pneumonia
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak.
For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is the best early treatment option for patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved vaccine for the disease and the treatments being used are not specifically designed for the SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with mechanisms of action that justify their use because they inhibit entry of the virus into virus cells or proteases.
Read more
The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment, administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.
Patients who meet inclusion criteria and do not have any exclusion criteria will be randomized to receive open treatment 1:1:1
Read the detailed description
Identifying treatment options is critical to the SARS-CoV-2 outbreak response. Currently there is no vaccine and treatments used are not specifically designed for this virus; They are drugs used for other pathologies. We have identified possible drugs with a known safety profile, selected the most promising ones and designed 3 combinations to select the one with the best results in clinical improvement of pneumonia due to Covid-19.
-Virus entry inhibitors: broad spectrum antivirals (antimalarials). They block viral infection by increasing endosomal pH necessary for virus / cell fusion, as well as interfering with glycosylation of cellular SARS-CoV receptors. It also has immunomodulatory activity, which can enhance antiviral effect. Latest evidence from the UK RECOVERY and WHO SOLIDARITY trials suggest that antimalarials do not provide clinical benefit in hospitalized patients with COVID-19.
Baricitinib, Janus kinase inhibitor, showing high affinity for AAK1. Disruption of AAK1 (one of the known regulators of viral endocytosis) could block passage of SARS-CoV-2 to cells and also the intracellular assembly of virus particles. Furthermore, it has the capacity to bind cyclin G-associated kinase, another regulator of endocytosis. You can limit systemic inflammatory response and cytokine production by inhibiting the JAK-STAT32 pathway.
Imatinib; Antitumor agent inhibitory activity of some tirsin kinases (TK), especially fusion oncoprotein BCR-ABL1, c-kit and native kinase ABL1. It has shown antiviral properties in early stages of infection against SARS-CoV and MERS-CoV, phylogenetically related to SARS-CoV2. In addition, it has been linked to reduced inflammation and improved endothelial barrier and pulmonary edema.
-Protease inhibitors: lopinavir / ritonavir (HIV treatment); expected interactions with SARS-CoV-2 proteases; The therapeutic effect of ritonavir and lopinavir could be mainly due to its inhibitory effect on coronavirus endopeptidase C30. The RECOVERY clinical trial investigators have also reviewed the data concluding that LPV / r does not provide clinical benefit in hospitalized patients with COVID-19.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Imatinib tablets, Baricitinib Oral Tablet, Supportive tratment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib tabletsDrug
Also called Arm A
Imatinib 400 mg QD oral
Baricitinib Oral TabletDrug
Also called Arm B
Baricitinib 4 mg QD oral
Supportive tratmentOther
Also called Best care
Any therapeutic intervention aimed at the control of clinical deterioration is contemplated without initiating or having previously initiated any drug with potential beneficial effect previously described in vitro or in pre-clinical / clinical models against SARS-CoV-2 prior to patient recruitment.
| Study group | Role | What they receive |
|---|---|---|
| Imatinib 400 mg | Experimental | Imatinib 400 mg 1 tablet 24 hours Receives: Drug: Imatinib tablets |
| Baricitinib 4 mg | Experimental | Baricitinib 4 mg 1 tablet 24 hours Receives: Drug: Baricitinib Oral Tablet |
| Supportive treatment | Experimental | Any therapeutic intervention aimed at the control of clinical deterioration is contemplated without initiating or having previously initiated any drug with potential beneficial effect previously described in vitro or in pre-clinical / clinical models against SARS-CoV-2 prior to patient recruitment. Receives: Other: Supportive tratment |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to clinical improvement
time from inclusion to improvement by 2 points on the "seven-category ordinal scale" or high, whichever comes first
Measured: baseline to day 14
Secondary outcomes (2)
Safety of treatments
number of serious adverse effects and premature discontinuation of treatment
Measured: through study completion, an average of 1 month
Tolerability of treatments
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: during treatment and up to 30 days after the last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start7 May 2020
- Primary completion2 Jun 2021
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Fuenlabrada
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Responsible party
- Sponsor
- Investigators
- David Bernal, Ph MD, Principal investigator, Hospital Universitario de Fuenlabrada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346147
- Sponsor's protocol ID
- 24032020
- Acronym
- Covid19COVINIB
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Phase II, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Baricitinib, Imatinib or Supportive Treatment in Patients With SARS Cov2 Pneumonia
- ClinicalTrials.gov ID
- NCT04346147
- Acronym / sponsor ID
- Covid19COVINIB / 24032020
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hospital Universitario de FuenlabradaUniversity, hospital or other
- Collaborators
- Centro Nacional de Investigaciones Oncologicas CARLOS III
- Study start
- 7 May 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 15 Apr 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.
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak.
For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is the best early treatment option for patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved vaccine for the disease and the treatments being used are not specifically designed for the SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with mechanisms of action that justify their use because they inhibit entry of the virus into virus cells or proteases.
The study aims to compare Imatinib 400mg, Baricitinib 4mg or supportive treatment, administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment.
Patients who meet inclusion criteria and do not have any exclusion criteria will be randomized to receive open treatment 1:1:1
Detailed description
Identifying treatment options is critical to the SARS-CoV-2 outbreak response. Currently there is no vaccine and treatments used are not specifically designed for this virus; They are drugs used for other pathologies. We have identified possible drugs with a known safety profile, selected the most promising ones and designed 3 combinations to select the one with the best results in clinical improvement of pneumonia due to Covid-19.
-Virus entry inhibitors: broad spectrum antivirals (antimalarials). They block viral infection by increasing endosomal pH necessary for virus / cell fusion, as well as interfering with glycosylation of cellular SARS-CoV receptors. It also has immunomodulatory activity, which can enhance antiviral effect. Latest evidence from the UK RECOVERY and WHO SOLIDARITY trials suggest that antimalarials do not provide clinical benefit in hospitalized patients with COVID-19.
Baricitinib, Janus kinase inhibitor, showing high affinity for AAK1. Disruption of AAK1 (one of the known regulators of viral endocytosis) could block passage of SARS-CoV-2 to cells and also the intracellular assembly of virus particles. Furthermore, it has the capacity to bind cyclin G-associated kinase, another regulator of endocytosis. You can limit systemic inflammatory response and cytokine production by inhibiting the JAK-STAT32 pathway.
Imatinib; Antitumor agent inhibitory activity of some tirsin kinases (TK), especially fusion oncoprotein BCR-ABL1, c-kit and native kinase ABL1. It has shown antiviral properties in early stages of infection against SARS-CoV and MERS-CoV, phylogenetically related to SARS-CoV2. In addition, it has been linked to reduced inflammation and improved endothelial barrier and pulmonary edema.
-Protease inhibitors: lopinavir / ritonavir (HIV treatment); expected interactions with SARS-CoV-2 proteases; The therapeutic effect of ritonavir and lopinavir could be mainly due to its inhibitory effect on coronavirus endopeptidase C30. The RECOVERY clinical trial investigators have also reviewed the data concluding that LPV / r does not provide clinical benefit in hospitalized patients with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imatinib 400 mg | Experimental | Drug: Imatinib tabletsImatinib 400 mg 1 tablet 24 hours |
| Baricitinib 4 mg | Experimental | Drug: Baricitinib Oral TabletBaricitinib 4 mg 1 tablet 24 hours |
| Supportive treatment | Experimental | Other: Supportive tratmentAny therapeutic intervention aimed at the control of clinical deterioration is contemplated without initiating or having previously initiated any drug with potential beneficial effect previously described in vitro or in pre-clinical / clinical models against SARS-CoV-2 prior to patient recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent form
- ≥18 years
- Confirmed diagnosis Pneumonia Covid19 + (Pneumonia confirmed radiologically and positive test for detection of SARS-CoV-2 RNA in respiratory samples)
- ECOG functional state 0 or 1
- Less than 10 days from onset of symptoms saw.
Key exclusion criteria (20 listed)
- No Covid confirmation
- No pneumonia
- Previous treatment with any of the study drugs
- Concomitant serious medical condition:
- Inability to take oral medication or malabsorption syndrome saw.
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 tabletsAlso: Arm AImatinib 400 mg QD oral | Drug | Imatinib 400 mg |
| Baricitinib Oral TabletAlso: Arm BBaricitinib 4 mg QD oral | Drug | Baricitinib 4 mg |
| Supportive tratmentAlso: Best careAny therapeutic intervention aimed at the control of clinical deterioration is contemplated without initiating or having previously initiated any drug with potential beneficial effect previously described in vitro or in pre-clinical / clinical models against SARS-CoV-2 prior to patient recruitment. | Other | Supportive treatment |
Primary outcome
time to clinical improvement
Time frame: baseline to day 14
time from inclusion to improvement by 2 points on the "seven-category ordinal scale" or high, whichever comes first
2 secondary outcomes
Safety of treatments
Time frame: through study completion, an average of 1 month
Tolerability of treatments
Time frame: during treatment and up to 30 days after the last treatment dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- 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.
David Bernal, Ph MD principal investigator
Hospital Universitario de Fuenlabrada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib tablets, Baricitinib Oral Tablet and Supportive tratment in people with COVID-19 Pneumonia, run by Hospital Universitario de Fuenlabrada at 1 site in Spain.
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 14 inclusion and 20 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to clinical improvement (time frame: baseline to day 14). 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 3 Aug 2021.