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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
125 mg of palbociclib once daily for 21 consecutive days
Universitätsklinikum Brandenburg an der Havel
Brandenburg, Germany
Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment
Time frame: 21 days
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
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