NCT05371275

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

April 26, 2022

Last Update Submit

November 3, 2022

Conditions

COVID-19

Keywords

COVID-19moderatehospitalizedPalbociclibCDK4/6 inhibition

Outcome Measures

Primary Outcomes (1)

  • Rate of treatment-related treatment discontinuation after 21 days of palbociclib treatment

    21 days

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Palbociclib

EXPERIMENTAL

125 mg of palbociclib once daily for 21 consecutive days

Drug: Palbociclib

Interventions

PalbociclibDRUG

125 mg of palbociclib once daily for 21 consecutive days

Palbociclib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Brandenburg an der Havel

Brandenburg, 14770, Germany

Location

MeSH Terms

Conditions

COVID-19Lymphoma, Follicular

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Mark Reinwald, PD Dr. med.

    Universitätsklinikum Brandenburg an der Havel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 12, 2022

Study Start

April 21, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

DE(1)