COVID-19Phase 2COVIDENZANCT04475601
Enzalutamide Treatment in COVID-19
A Phase 2 study testing Enzalutamide Pill in people with COVID-19 and Corona Virus Infection, run by Andreas Josefsson at 6 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COVID-19, Corona Virus Infection
- What is being tested?
- Enzalutamide Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesSweden
- Study dates
- 15 Jul 2020to 29 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Sahlgrenska University Hospital
Gothenburg
Ryhovs Hospital
Jönköping, Småland
Linköping University Hospital
Linköping
Anders Bjartell
Malmö, Skåne County
Sundsvall Region Hosptial
Sundsvall
Umeå Univerisity Hospital
Umeå
About this study
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)
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.
- Conditions
- COVID-19, Corona Virus Infection
- Being tested
- Enzalutamide Pill
- Keywords
- Enzalutamide, Randomized clinical trial, COVID-19, Sars-CoV2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide PillDrug
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide+Standard of Care | Experimental | Up to 5 days with 4x40 mg enzalutamide tablets orally once daily Receives: Drug: Enzalutamide Pill |
| Standard of Care | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to worsening of disease
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Measured: Up to 30 days after inclusion
Time to improvement of disease
Time to discharge from hospital assessed by the 7-point ordinal scale
Measured: Up to 30 days after inclusion
Secondary outcomes (16)
Adverse events
Safety evaluation, as measured by AEs
Measured: Up to 6 months
Duration of supplemental oxygen (days)
Total days of extra oxygen
Measured: Up to 30 days
Admission to ICU
Frequence of admission to ICU
Measured: Up to 30 days and up to 6 months
Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6
Changes of laboratory parameters: Hb
Measured: Up to 30 days
Virus load assessment day 0, 2, 4 and 6
PCR based SARS-CoV-2 measurement from upper respiratory tract
Measured: UP to 7 days
Hospital stay (days)
Total number of days evaluated at 30 days and 6 months
Measured: Up to30 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
Measured: Evaluated for 30 days and after 6 months
Mortality at 6 months
Death due to any cause
Measured: up to 30 days and up to 6 months respectively
Laboratory assessment of CRP concentration day 0, 2, 4 and 6
Changes of laboratory parameters: CRP
Measured: Up to 30 days
Laboratory assessment of liver function day 0, 2, 4 and 6
Changes of laboratory parameters: ALAT, ASTA and/or ALP
Measured: Up to 30 days
Laboratory assessment of creatinine concentration day 0, 2, 4 and 6
Changes of laboratory parameters: Createnin
Measured: Up to 30 days
Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6
Changes of laboratory parameters: D-dimer
Measured: Up to 30 days
Laboratory assessment of platelets concentration day 0, 2, 4 and 6
Changes of laboratory parameters: TPK
Measured: Up to 30 days
Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6
Changes of laboratory parameters: IL-6
Measured: Up to 30 days
Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6
Changes of laboratory parameters: Differentiate count of leucocytes
Measured: Up to 30 days
Pharmacokinetic interaction of enzalutamide with steroids
Maximum Plasma Concentration [Cmax] of steroids in blood
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start15 Jul 2020
- Primary completion24 Mar 2021
- Study completion29 May 2021
Why it stopped: By sponsor, based on DSMB recommendations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized (2:1), open, multicentre, clinical controlled trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Josefsson
- Sponsor type
- Other government
- Collaborators
- Umeå University, Sahlgrenska University Hospital, 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
- Responsible party
- Sponsor-investigator, Andreas Josefsson, Region Västerbotten
- Investigators
- Andreas Josefsson, MdPhD, Principal investigator, Norrlands University Hospital, Region Västerbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475601
- Sponsor's protocol ID
- COVIDENZA
- Acronym
- COVIDENZA
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws
Publications
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.
PubMed 33726804
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04475601
- Acronym / sponsor ID
- COVIDENZA / COVIDENZA
- Conditions
- COVID-19, Corona Virus Infection
- Keywords
- Enzalutamide, Randomized clinical trial, COVID-19, Sars-CoV2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: By sponsor, based on DSMB recommendations
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Andreas JosefssonOther government
- Collaborators
- Umeå University, Sahlgrenska University Hospital, 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
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 29 May 2021 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized (2:1), open, multicentre, clinical controlled trial
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide+Standard of Care | Experimental | Drug: Enzalutamide PillUp to 5 days with 4x40 mg enzalutamide tablets orally once daily |
| Standard of Care | No intervention | –Standard of care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Positive COVID-19 test
- Mild to severe symptoms of COVID-19
- Hospitalization
- WHO performance status 0-3
- Age above or equal to 50 years
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzalutamide PillThe once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital | Drug | Enzalutamide+Standard of Care |
Primary outcome
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
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
16 secondary outcomes
Adverse events
Time frame: Up to 6 months
Duration of supplemental oxygen (days)
Time frame: Up to 30 days
Admission to ICU
Time frame: 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
Virus load assessment day 0, 2, 4 and 6
Time frame: UP to 7 days
Hospital stay (days)
Time frame: 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
Mortality at 6 months
Time frame: 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
Laboratory assessment of liver function day 0, 2, 4 and 6
Time frame: Up to 30 days
Laboratory assessment of creatinine concentration day 0, 2, 4 and 6
Time frame: Up to 30 days
Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6
Time frame: Up to 30 days
Laboratory assessment of platelets concentration day 0, 2, 4 and 6
Time frame: Up to 30 days
Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6
Time frame: Up to 30 days
Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6
Time frame: Up to 30 days
Pharmacokinetic interaction of enzalutamide with steroids
Time frame: Up to 30 days
Results and safety
The study was stopped early (reason given: By sponsor, based on DSMB recommendations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 33726804Welen 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.
- Publication of the resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Josefsson, MdPhD principal investigator
Norrlands University Hospital, Region Västerbotten
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide Pill in people with COVID-19 and Corona Virus Infection, run by Andreas Josefsson at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: By sponsor, based on DSMB recommendations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to worsening of disease (time frame: Up to 30 days after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.