Status:
WITHDRAWN
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
Lead Sponsor:
biotx.ai GmbH
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 thu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05371275
Start Date
April 21 2022
End Date
December 1 2022
Last Update
November 7 2022
Active Locations (1)
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1
Universitätsklinikum Brandenburg an der Havel
Brandenburg, Germany, 14770