COVID-19 InfectionPhase 2NCT04456049
Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
A Phase 2 study testing Enzalutamide in people with COVID-19 Infection, run by Ricardo Pereira Mestre at 1 site in Switzerland.
Trial summary
High risk outpatient adult males with a confirmed SARS-CoV-2 infection will be included in the study. Patients will be randomized to receive Enzalutamide with standard of care (SOC) or SOC alone. Enzalutamide will be administered daily p.o. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Aug 2020to 9 Jun 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented COVID-19 infection (confirmed by NPS positive PCR for SARS-CoV-2) with mild symptoms not requiring hospitalization
- First NPS ≤4 days (96 hours) since onset of symptoms
- Randomization ≤72 hours since first NPS
- Adult Males aged ≥ 50 years
- Indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, COPD)
- WHO performance status 0-1
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- Adequate hematologic values: haemoglobin ≥ 100 g/L, neutrophils ≥ 1.0 x 10(9)/L, platelets ≥ 150 x 10(9)/L.
- Adequate hepatic function: ALT and AST ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN (exception if Gilbert's syndrome ≤ 2.5 x ULN)
- Adequate renal function: calculated creatinine clearance ≥ 50 mL/min according to the formula of Cockcroft-Gault
- Patient is able to swallow the trial drugs and to comply with trial requirements
- Patient agrees not to father a child during participation in the trial and for 3 months thereafter
Who cannot join
- Female sex
- Moderate to severe COVID-19 symptoms requiring hospitalization
- Patients requiring inpatient treatment
- Concurrent antiviral drugs or ongoing interventional clinical trial or any off label drug for COVID-19
- Patients with ongoing prostate cancer treatment
- Clinically significant cardiovascular disease including:
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- Myocardial infarction within 6 months prior to registration,
- Uncontrolled angina within 3 months prior to registration,
- Congestive heart failure NYHA class III or VI
- QTc interval > 480 ms
- History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- History of Mobitz II second or third degree heart block without a permanent pacemaker in place
- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg
- Deep venous thrombosis or pulmonary embolism within 6 months
- History of cerebrovascular disease
- Severe concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrolment.
- Known history of HIV, hepatitis B, hepatitis C
- Known history of seizures or any conditions that may predispose to seizure. History of loss of consciousness or ischemic cerebrovascular attack within 12 months prior to registration
- Concurrent anticoagulation with rivaroxaban or warfarin. Concomitant and continuous use of systemic corticosteroids exceeding 10 mg/day of prednisone or a dose equivalent corticosteroid within 14 days before registration.
- Known hypersensitivity to Enzalutamide or hypersensitivity to any of its components
- Any concomitant drugs contraindicated for use with Enzalutamide according to the Swissmedic approved product information
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, 6500
About this study
Official title: COVID_ENZA Trial: Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
High risk outpatient adult males with a confirmed SARS-CoV-2 infection will be included in the study.
Patients will be randomized to receive Enzalutamide with standard of care (SOC) or SOC alone. Enzalutamide will be administered daily p.o. from Day 1 to Day 28 or until confirmed negativization of Nasopharyngeal swap (NPS) Polymerase chain reaction (PCR) (2 consecutive negative samples), whichever occurs first.
- Conditions
- COVID-19 Infection
- Being tested
- Enzalutamide
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called XTANDI
40 mg oral tablets once daily for a maximum of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide (Xtandi®) | Experimental | Interventional treatment Receives: Drug: Enzalutamide |
| Standard of care (SOC) | Active comparator | Supportive treatment Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
efficacy of Enzalutamide in decreasing the nasopharyngeal swap SARS-CoV-2 viral load until negativization
Measured: 28 days
Secondary outcomes (2)
Tollerability of Enzalutamide by identifying Adverse Events
Evaluation of Enzalutamide tolerability in terms of incidence and severity grade of side effects
Measured: 28 days
Disease progression by unresolved SARS-CoV-2 viral expression after treatment
Efficacy of Enzalutamide in controlling disease progression of SARS-CoV-2 viral load
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start24 Aug 2020
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo Pereira Mestre
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Institute of Southern Switzerland, Institute of Oncology Research, Institute for Research in Biomedicine
- Responsible party
- Sponsor-investigator, Ricardo Pereira Mestre, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456049
- Sponsor's protocol ID
- COVID_ENZA
- Status last verified
- Aug 2022
- First submitted
- 1 Jul 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID_ENZA Trial: Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
- ClinicalTrials.gov ID
- NCT04456049
- Acronym / sponsor ID
- COVID_ENZA
- Conditions
- COVID-19 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ricardo Pereira MestreUniversity, hospital or other
- Collaborators
- Oncology Institute of Southern Switzerland, Institute of Oncology Research, Institute for Research in Biomedicine
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 2 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.
High risk outpatient adult males with a confirmed SARS-CoV-2 infection will be included in the study.
Patients will be randomized to receive Enzalutamide with standard of care (SOC) or SOC alone. Enzalutamide will be administered daily p.o. from Day 1 to Day 28 or until confirmed negativization of Nasopharyngeal swap (NPS) Polymerase chain reaction (PCR) (2 consecutive negative samples), whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide (Xtandi®) | Experimental | Drug: EnzalutamideInterventional treatment |
| Standard of care (SOC) | Active comparator | Drug: EnzalutamideSupportive treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documented COVID-19 infection (confirmed by NPS positive PCR for SARS-CoV-2) with mild symptoms not requiring hospitalization
- First NPS ≤4 days (96 hours) since onset of symptoms
- Randomization ≤72 hours since first NPS
- Adult Males aged ≥ 50 years
- Indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, COPD)
Key exclusion criteria (22 listed)
- Female sex
- Moderate to severe COVID-19 symptoms requiring hospitalization
- Patients requiring inpatient treatment
- Concurrent antiviral drugs or ongoing interventional clinical trial or any off label drug for COVID-19
- Patients with ongoing prostate cancer treatment
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 |
|---|---|---|
| EnzalutamideAlso: XTANDI40 mg oral tablets once daily for a maximum of 28 days. | Drug | Enzalutamide (Xtandi®), Standard of care (SOC) |
Primary outcome
Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
Time frame: 28 days
efficacy of Enzalutamide in decreasing the nasopharyngeal swap SARS-CoV-2 viral load until negativization
2 secondary outcomes
Tollerability of Enzalutamide by identifying Adverse Events
Time frame: 28 days
Disease progression by unresolved SARS-CoV-2 viral expression after treatment
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with COVID-19 Infection, run by Ricardo Pereira Mestre at 1 site in Switzerland.
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 11 inclusion and 22 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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: Low accrual). 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?
Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2022; AzTrials last refreshed its copy on 5 Nov 2026.