Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation
NCT05371275 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-11-07
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.
Conditions
Interventions
- DRUG
-
125 mg of palbociclib once daily for 21 consecutive days
Sponsors & Collaborators
-
biotx.ai GmbH
lead INDUSTRY
Principal Investigators
-
Mark Reinwald, PD Dr. med. · Universitätsklinikum Brandenburg an der Havel
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-21
- Primary Completion
- 2022-10-31
- Completion
- 2022-12-31
Countries
- Germany
Study Locations
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