CDK6COV: Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation

Sponsor

biotx.ai GmbH (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05371275

Collaborator

(none)

Enrollment

Location

Arm

7.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Palbociclib	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation

Actual Study Start Date :

Apr 21, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Palbociclib 125 mg of palbociclib once daily for 21 consecutive days	Drug: Palbociclib 125 mg of palbociclib once daily for 21 consecutive days

Arm

Intervention/Treatment

Experimental: Palbociclib

125 mg of palbociclib once daily for 21 consecutive days

Drug: Palbociclib

125 mg of palbociclib once daily for 21 consecutive days

Outcome Measures

Primary Outcome Measures

Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment [21 days]

Secondary Outcome Measures

Time to freedom from oxygenation, measured in days after the first treatment dose. [90 days]
Time to transfer to ICU [90 days]
Course of neutrophil cell count during treatment [21 days]
Course of D-dimer during treatment [21 days]
Rate of thrombotic events during treatment [21 days]
Course of O2 saturation during treatment [21 days]
Rate of persisting symptoms after 3, 6, 9 and 12 months [Through completion of safety follow-up up to 12 month]
Dose reduction rate [21 days]
Rate of (S)AEs at day 21 [at day 21]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.

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