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Enzalutamide Treatment in COVID-19 (COVIDENZA)

Primary Purpose

COVID-19, Corona Virus Infection

Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Enzalutamide Pill
Sponsored by
Andreas Josefsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Enzalutamide, Randomized clinical trial, COVID-19, Sars-CoV2

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive COVID-19 test
  • Mild to severe symptoms of COVID-19
  • Hospitalization
  • WHO performance status 0-3
  • Age above or equal to 50 years
  • Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
  • Estimated expected survival of 1 year (excluding symptoms due to COVID-19)

Exclusion Criteria:

  • Severe allergy to Enzalutamide
  • Pregnant or breast-feeding women
  • Need of immediate mechanical ventilation
  • Current medication includes enzalutamide treatment
  • Stroke or Transitory Ischemic attack in medical history
  • Treatment for HIV
  • Treatment with tamoxifen
  • Treatment with immunosuppressive agents
  • Severe immunosuppressive disease
  • Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
  • Previous seizure in medical history
  • Other serious illness or medical condition
  • Unstable cardiovascular disease

Sites / Locations

  • Anders Bjartell
  • Ryhovs Hospital
  • Sahlgrenska University Hospital
  • Linköping University Hospital
  • Sundsvall Region Hosptial
  • Umeå Univerisity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enzalutamide+Standard of Care

Standard of Care

Arm Description

Up to 5 days with 4x40 mg enzalutamide tablets orally once daily

Standard of care

Outcomes

Primary Outcome Measures

Time to worsening of disease
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Time to improvement of disease
Time to discharge from hospital assessed by the 7-point ordinal scale

Secondary Outcome Measures

Adverse events
Safety evaluation, as measured by AEs
Duration of supplemental oxygen (days)
Total days of extra oxygen
Admission to ICU
Frequence of admission to ICU
Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6
Changes of laboratory parameters: Hb
Virus load assessment day 0, 2, 4 and 6
PCR based SARS-CoV-2 measurement from upper respiratory tract
Hospital stay (days)
Total number of days evaluated at 30 days and 6 months
Re-admission to hospital due to rebound COVID-19
If admitted to hospital due to COVID-19 disease after discharge from hospital
Mortality at 6 months
Death due to any cause
Laboratory assessment of CRP concentration day 0, 2, 4 and 6
Changes of laboratory parameters: CRP
Laboratory assessment of liver function day 0, 2, 4 and 6
Changes of laboratory parameters: ALAT, ASTA and/or ALP
Laboratory assessment of creatinine concentration day 0, 2, 4 and 6
Changes of laboratory parameters: Createnin
Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6
Changes of laboratory parameters: D-dimer
Laboratory assessment of platelets concentration day 0, 2, 4 and 6
Changes of laboratory parameters: TPK
Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6
Changes of laboratory parameters: IL-6
Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6
Changes of laboratory parameters: Differentiate count of leucocytes
Pharmacokinetic interaction of enzalutamide with steroids
Maximum Plasma Concentration [Cmax] of steroids in blood

Full Information

First Posted
June 8, 2020
Last Updated
May 30, 2022
Sponsor
Andreas Josefsson
Collaborators
Umeå University, Sahlgrenska University Hospital, Sweden, University Hospital, Umeå, Uppsala University Hospital, Skane University Hospital, Jonkoping County Hospital, Sundsvall Hospital, Helsingborgs Hospital, Göteborg University, Astellas Pharma Europe Ltd., Norrlands University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04475601
Brief Title
Enzalutamide Treatment in COVID-19
Acronym
COVIDENZA
Official Title
A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
By sponsor, based on DSMB recommendations
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
May 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andreas Josefsson
Collaborators
Umeå University, Sahlgrenska University Hospital, Sweden, University Hospital, Umeå, Uppsala University Hospital, Skane University Hospital, Jonkoping County Hospital, Sundsvall Hospital, Helsingborgs Hospital, Göteborg University, Astellas Pharma Europe Ltd., Norrlands University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Corona Virus Infection
Keywords
Enzalutamide, Randomized clinical trial, COVID-19, Sars-CoV2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized (2:1), open, multicentre, clinical controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide+Standard of Care
Arm Type
Experimental
Arm Description
Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Enzalutamide Pill
Intervention Description
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
Primary Outcome Measure Information:
Title
Time to worsening of disease
Description
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Time Frame
Up to 30 days after inclusion
Title
Time to improvement of disease
Description
Time to discharge from hospital assessed by the 7-point ordinal scale
Time Frame
Up to 30 days after inclusion
Secondary Outcome Measure Information:
Title
Adverse events
Description
Safety evaluation, as measured by AEs
Time Frame
Up to 6 months
Title
Duration of supplemental oxygen (days)
Description
Total days of extra oxygen
Time Frame
Up to 30 days
Title
Admission to ICU
Description
Frequence of admission to ICU
Time Frame
Up to 30 days and up to 6 months
Title
Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: Hb
Time Frame
Up to 30 days
Title
Virus load assessment day 0, 2, 4 and 6
Description
PCR based SARS-CoV-2 measurement from upper respiratory tract
Time Frame
UP to 7 days
Title
Hospital stay (days)
Description
Total number of days evaluated at 30 days and 6 months
Time Frame
Up to30 days and 6 months
Title
Re-admission to hospital due to rebound COVID-19
Description
If admitted to hospital due to COVID-19 disease after discharge from hospital
Time Frame
Evaluated for 30 days and after 6 months
Title
Mortality at 6 months
Description
Death due to any cause
Time Frame
up to 30 days and up to 6 months respectively
Title
Laboratory assessment of CRP concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: CRP
Time Frame
Up to 30 days
Title
Laboratory assessment of liver function day 0, 2, 4 and 6
Description
Changes of laboratory parameters: ALAT, ASTA and/or ALP
Time Frame
Up to 30 days
Title
Laboratory assessment of creatinine concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: Createnin
Time Frame
Up to 30 days
Title
Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: D-dimer
Time Frame
Up to 30 days
Title
Laboratory assessment of platelets concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: TPK
Time Frame
Up to 30 days
Title
Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: IL-6
Time Frame
Up to 30 days
Title
Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6
Description
Changes of laboratory parameters: Differentiate count of leucocytes
Time Frame
Up to 30 days
Title
Pharmacokinetic interaction of enzalutamide with steroids
Description
Maximum Plasma Concentration [Cmax] of steroids in blood
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive COVID-19 test Mild to severe symptoms of COVID-19 Hospitalization WHO performance status 0-3 Age above or equal to 50 years Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information. Estimated expected survival of 1 year (excluding symptoms due to COVID-19) Exclusion Criteria: Severe allergy to Enzalutamide Pregnant or breast-feeding women Need of immediate mechanical ventilation Current medication includes enzalutamide treatment Stroke or Transitory Ischemic attack in medical history Treatment for HIV Treatment with tamoxifen Treatment with immunosuppressive agents Severe immunosuppressive disease Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants) Previous seizure in medical history Other serious illness or medical condition Unstable cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Josefsson, MdPhD
Organizational Affiliation
Norrlands University Hospital, Region Västerbotten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anders Bjartell
City
Malmö
State/Province
Skåne
Country
Sweden
Facility Name
Ryhovs Hospital
City
Jönköping
State/Province
Småland
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Sundsvall Region Hosptial
City
Sundsvall
Country
Sweden
Facility Name
Umeå Univerisity Hospital
City
Umeå
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws
Citations:
PubMed Identifier
33726804
Citation
Welen K, Overby AK, Ahlm C, Freyhult E, Robinsson D, Henningsson AJ, Stranne J, Bremell D, Angelin M, Lindquist E, Buckland R, Carlsson CT, Pauksens K, Bill-Axelsson A, Akre O, Ryden C, Wagenius M, Bjartell A, Nilsson AC, Styrke J, Repo J, Balkhed AO, Niward K, Gisslen M, Josefsson A. COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Mar 16;22(1):209. doi: 10.1186/s13063-021-05137-4.
Results Reference
derived
Links:
URL
https://doi.org/10.1016/j.eururo.2021.12.013
Description
Publication of the results

Learn more about this trial

Enzalutamide Treatment in COVID-19

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