COVID-19Phase 2CDK6COVNCT05371275
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
A Phase 2 study testing Palbociclib in people with COVID-19, run by biotx.ai GmbH at 1 site in Germany.
Trial summary
This is a one-site, interventional, prospective, single-arm, open-label, controlled phase-IIa trial evaluating the safety and efficacy of palbociclib in hospitalized, moderate COVID- 19 cases. 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?
- Palbociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2022to Dec 2022
- 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
- age >= 18 years
- positive PCR COVID-19 test (max. 72h old)
- known vaccination status
- ANC >= 1,000/mm3 and platelets >= 50,000/mm3
- willingness to participate (written informed consent)
- established risk factors for a severe course of COVID-19-disease, for example: adipositas, cardiovascular disease including arterial hypertension, advanced age > 60, chronic lung disease including asthma, diabetis type I or II, chronic kidney disease, chronic liver disease
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- Oxygen supply: ≤ 2 liters/minute
- Women of childbearing potential (WOCBP): must have a negative pregnancy test (ß- HCG urine or serum test) a. WOCBP is considered as i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile.
- Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Use of highly effective contraception method
- All potentially fertile participants, or their male partners, must use an adequate, medically approved method of contraception or agree to abstinence during and at least 3 weeks (females) and 14 weeks (males) after treatment with Palbociclib.
- For females, highly effective birth control should be used, i.e., combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, or intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomized partner. As there is no information available on the interaction of palbociclib with oral contraceptives, a double-barrier contraception is necessary in this case.
- Males must agree to use a condom for at least 14 weeks after the treatment phase.
Who cannot join
- age < 18 year
- ECOG >= 3
- ANC < 1,000/mm3 and platelets < 50,000/mm3
- intensive care patient
- treatment with any other CDK4/6 Inhibitor
- pregnant or breast-feeding women
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- patients receiving immunosuppressants for other diseases (e.g. rheumatoid arthritis)
- known malignancy in the past 5 years other than basal cell carcinoma
- baseline O2-Saturation < 92%
- participation in any other medical device or medicinal product study within the previous month
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Brandenburg an der Havel
Brandenburg an der Havel, 14770
About this study
This is a one-site, interventional, prospective, single-arm, open-label, controlled phase-IIa trial evaluating the safety and efficacy of palbociclib in hospitalized, moderate COVID- 19 cases.
Read the detailed description
The study will include hospitalized, moderate COVID-19 cases that have a risk of respiratory failure.
The study will generally consist of:
- A short screening phase (1 day) before enrollment and thus treatment decision.
- A 21 day treatment phase with one "cycle" of palbociclib
- An up to day 90 Safety Follow-Up Phase
The first three patients will be enrolled and treated one by one; the independent safety data review committee (ISRC) will review each patient after D21 before enrollment of the subsequent patient is permitted.
- Conditions
- COVID-19
- Being tested
- Palbociclib
- Keywords
- COVID-19, moderate, hospitalized, Palbociclib, CDK4/6 inhibition
- Medical subject headings
- COVID-19, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
125 mg of palbociclib once daily for 21 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib | Experimental | 125 mg of palbociclib once daily for 21 consecutive days Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
Measured: 21 days
Secondary outcomes (9)
Time to freedom from oxygenation, measured in days after the first treatment dose.
Measured: 90 days
Time to transfer to ICU
Measured: 90 days
Course of neutrophil cell count during treatment
Measured: 21 days
Course of D-dimer during treatment
Measured: 21 days
Rate of thrombotic events during treatment
Measured: 21 days
Course of O2 saturation during treatment
Measured: 21 days
Rate of persisting symptoms after 3, 6, 9 and 12 months
Measured: Through completion of safety follow-up up to 12 month
Dose reduction rate
Measured: 21 days
Rate of (S)AEs at day 21
Measured: at day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start21 Apr 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Study was withdrawn due to challenges in patient enrollment
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- biotx.ai GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Reinwald, PD Dr. med., Principal investigator, Universitätsklinikum Brandenburg an der Havel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371275
- Sponsor's protocol ID
- BXAI-001
- Other IDs
- 2021-006770-24
- Acronym
- CDK6COV
- Status last verified
- Nov 2022
- First submitted
- 26 Apr 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
- ClinicalTrials.gov ID
- NCT05371275
- Acronym / sponsor ID
- CDK6COV / BXAI-001
- Conditions
- COVID-19
- Keywords
- COVID-19, moderate, hospitalized, Palbociclib, CDK4/6 inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to challenges in patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- biotx.ai GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 May 2022 (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.
This is a one-site, interventional, prospective, single-arm, open-label, controlled phase-IIa trial evaluating the safety and efficacy of palbociclib in hospitalized, moderate COVID- 19 cases.
Detailed description
The study will include hospitalized, moderate COVID-19 cases that have a risk of respiratory failure.
The study will generally consist of:
- A short screening phase (1 day) before enrollment and thus treatment decision.
- A 21 day treatment phase with one "cycle" of palbociclib
- An up to day 90 Safety Follow-Up Phase
The first three patients will be enrolled and treated one by one; the independent safety data review committee (ISRC) will review each patient after D21 before enrollment of the subsequent patient is permitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib | Experimental | Drug: Palbociclib125 mg of palbociclib once daily for 21 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- age >= 18 years
- positive PCR COVID-19 test (max. 72h old)
- known vaccination status
- ANC >= 1,000/mm3 and platelets >= 50,000/mm3
- willingness to participate (written informed consent)
Key exclusion criteria (10 listed)
- age < 18 year
- ECOG >= 3
- ANC < 1,000/mm3 and platelets < 50,000/mm3
- intensive care patient
- treatment with any other CDK4/6 Inhibitor
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 |
|---|---|---|
| Palbociclib125 mg of palbociclib once daily for 21 consecutive days | Drug | Palbociclib |
Primary outcome
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
Time frame: 21 days
9 secondary outcomes
Time to freedom from oxygenation, measured in days after the first treatment dose.
Time frame: 90 days
Time to transfer to ICU
Time frame: 90 days
Course of neutrophil cell count during treatment
Time frame: 21 days
Course of D-dimer during treatment
Time frame: 21 days
Rate of thrombotic events during treatment
Time frame: 21 days
Course of O2 saturation during treatment
Time frame: 21 days
Rate of persisting symptoms after 3, 6, 9 and 12 months
Time frame: Through completion of safety follow-up up to 12 month
Dose reduction rate
Time frame: 21 days
Rate of (S)AEs at day 21
Time frame: at day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
Mark Reinwald, PD Dr. med. principal investigator
Universitätsklinikum Brandenburg an der Havel
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 Palbociclib in people with COVID-19, run by biotx.ai GmbH at 1 site in Germany.
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 10 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: withdrawn, as of the sponsor's last update on 7 Nov 2022. 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 Germany. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment (time frame: 21 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 7 Nov 2022.