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

COVID-19 Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05371275
Study type Interventional
Source biotx.ai GmbH
Contact
Status Withdrawn
Phase Phase 2
Start date April 21, 2022
Completion date December 2022
View Details
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