Enzalutamide Treatment in COVID-19 (COVIDENZA)

May 30, 2022 updated by: Andreas Josefsson

A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Linköping, Sweden
        • Linköping University Hospital
      • Sundsvall, Sweden
        • Sundsvall Region Hosptial
      • Umeå, Sweden
        • Umeå Univerisity Hospital
    • Skåne
      • Malmö, Skåne, Sweden
        • Anders Bjartell
    • Småland
      • Jönköping, Småland, Sweden
        • Ryhovs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enzalutamide+Standard of Care
Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
Drug: Enzalutamide Pill
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
No Intervention: Standard of Care
Standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to worsening of disease
Time Frame: Up to 30 days after inclusion
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Up to 30 days after inclusion
Time to improvement of disease
Time Frame: Up to 30 days after inclusion
Time to discharge from hospital assessed by the 7-point ordinal scale
Up to 30 days after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to 6 months
Safety evaluation, as measured by AEs
Up to 6 months
Duration of supplemental oxygen (days)
Time Frame: Up to 30 days
Total days of extra oxygen
Up to 30 days
Admission to ICU
Time Frame: Up to 30 days and up to 6 months
Frequence of admission to ICU
Up to 30 days and up to 6 months
Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: Hb
Up to 30 days
Virus load assessment day 0, 2, 4 and 6
Time Frame: UP to 7 days
PCR based SARS-CoV-2 measurement from upper respiratory tract
UP to 7 days
Hospital stay (days)
Time Frame: Up to30 days and 6 months
Total number of days evaluated at 30 days and 6 months
Up to30 days and 6 months
Re-admission to hospital due to rebound COVID-19
Time Frame: Evaluated for 30 days and after 6 months
If admitted to hospital due to COVID-19 disease after discharge from hospital
Evaluated for 30 days and after 6 months
Mortality at 6 months
Time Frame: up to 30 days and up to 6 months respectively
Death due to any cause
up to 30 days and up to 6 months respectively
Laboratory assessment of CRP concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: CRP
Up to 30 days
Laboratory assessment of liver function day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: ALAT, ASTA and/or ALP
Up to 30 days
Laboratory assessment of creatinine concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: Createnin
Up to 30 days
Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: D-dimer
Up to 30 days
Laboratory assessment of platelets concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: TPK
Up to 30 days
Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: IL-6
Up to 30 days
Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6
Time Frame: Up to 30 days
Changes of laboratory parameters: Differentiate count of leucocytes
Up to 30 days
Pharmacokinetic interaction of enzalutamide with steroids
Time Frame: Up to 30 days
Maximum Plasma Concentration [Cmax] of steroids in blood
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andreas Josefsson

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Göteborg University
Umeå University
Sahlgrenska University Hospital, Sweden
Sundsvall Hospital
Skane University Hospital
Jonkoping County Hospital
University Hospital, Umeå
Uppsala University Hospital
Astellas Pharma Europe Ltd.
Helsingborgs Hospital
Norrlands University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Josefsson, MdPhD, Norrlands University Hospital, Region Västerbotten

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVIDENZA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Enzalutamide Pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings