Back to resultsPhase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation (CDK6COV)
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Palbociclib
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, moderate, hospitalized, Palbociclib, CDK4/6 inhibition
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
b. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
c. 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Universitätsklinikum Brandenburg an der Havel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Palbociclib
Arm Description
125 mg of palbociclib once daily for 21 consecutive days
Outcomes
Primary Outcome Measures
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
Secondary Outcome Measures
Time to freedom from oxygenation, measured in days after the first treatment dose.
Time to transfer to ICU
Course of neutrophil cell count during treatment
Course of D-dimer during treatment
Rate of thrombotic events during treatment
Course of O2 saturation during treatment
Rate of persisting symptoms after 3, 6, 9 and 12 months
Dose reduction rate
Rate of (S)AEs at day 21
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371275
Brief Title
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
Acronym
CDK6COV
Official Title
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study was withdrawn due to challenges in patient enrollment
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
biotx.ai GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, moderate, hospitalized, Palbociclib, CDK4/6 inhibition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palbociclib
Arm Type
Experimental
Arm Description
125 mg of palbociclib once daily for 21 consecutive days
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Intervention Description
125 mg of palbociclib once daily for 21 consecutive days
Primary Outcome Measure Information:
Title
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Time to freedom from oxygenation, measured in days after the first treatment dose.
Time Frame
90 days
Title
Time to transfer to ICU
Time Frame
90 days
Title
Course of neutrophil cell count during treatment
Time Frame
21 days
Title
Course of D-dimer during treatment
Time Frame
21 days
Title
Rate of thrombotic events during treatment
Time Frame
21 days
Title
Course of O2 saturation during treatment
Time Frame
21 days
Title
Rate of persisting symptoms after 3, 6, 9 and 12 months
Time Frame
Through completion of safety follow-up up to 12 month
Title
Dose reduction rate
Time Frame
21 days
Title
Rate of (S)AEs at day 21
Time Frame
at day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
b. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
c. 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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Reinwald, PD Dr. med.
Organizational Affiliation
Universitätsklinikum Brandenburg an der Havel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Brandenburg an der Havel
City
Brandenburg an der Havel
ZIP/Postal Code
14770
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
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